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Tranexamic Acid in Endoscopic Sinus Surgery Pak Armed Forces Med J 2020; 70 (1): 17-21
17
HHAAEEMMOOSSTTAATTIICC RROOLLEE OOFF TTRRAANNEEXXAAMMIICC AACCIIDD IINN EENNDDOOSSCCOOPPIICC SSIINNUUSS SSUURRGGEERRYY ––
AANN IINNTTEERRVVEENNTTIIOONNAALL SSTTUUDDYY
Farhan Halim, Zaheer Ul Hassan*, Tarique Ahmed Maka**, Kinza Shakil, Adnan Halim***, Aliya Halim***
Combined Military Hospital, Bannu Pakistan, *Combined Military Hospital, Peshawar Pakistan, **Combined Military Hospital, Risalpur
Pakistan, ***Pak Emirates Military Hospital/National University of Medical Sciences (NUMS) Rawalpindi Pakistan
ABSTRACT
Objective: To compare preoperative intravenous tranexamic acid with placebo in terms of operative estimated
blood loss, in patients undergoing endoscopic sinus surgery.
Study Design: Quasi experimental study.
Place and Duration of Study: Department of ENT, CMH Peshawar, from Jan 2017 to Jun 2017.
Methodology: Patients were divided into 2 groups by lottery method. The case group received intravenous
tranexamic acid 15mg/kg body weight in 100 ml of normal saline and the control group received 100 ml of
normal saline only in identical syringes 15 minutes before start of surgery. At the end of surgery intraoperative
hemorrhage was estimated by estimating for blood loss based on the contents of suction container after
subtracting the irrigation fluid and the nasopharyngeal packing measurement via electronic scale (1ml of blood
weighs 1 gram).
Results: In our study, 30 (46.15%) in case group and 37 (56.92%) in control group were between the age of 18-30
years whereas 35 (53.85%) in case group and 28 (43.08%) in control group were between the age of 31-50 years.
Mean ± SD was calculated as 32.0 ± 6.29 in case group and 31.78 ± 6.59 years in control group, 34 (52.31%) in case
group and 29 (44.62%) in control group were males while 31 (47.69%) in case group and 36 (55.38%) in control
group were females. Evaluation of mean blood loss in both groups was done, it shows 104.15 ± 3.44 ml in case
group and 184.32 ±10.14 ml in control group, p-value was 0.0001.
Conclusion: We concluded that preoperative intravenous tranexamic acid significantly reduces operative
estimated blood volume loss when compared to placebo in patients undergoing endoscopic para nasal sinus
surgical procedures.
Keywords: Endoscopic paranasal sinus surgery, preoperative intravenous tranexamic acid, estimated peri-
operative blood volume loss.
INTRODUCTION
Endoscopic sinus surgery is one of the
modern technique of removing pathological
lesions of the nasal cavity and paranasal sinuses
including nasal polyposis and sinusitis. The pro-
cedure is preferred over conventional nasal sur-
gery due to its higher success rate and lesser
chances of complications1. Bleeding during
surgery is a common inevitable complication and
a cause of major concern. Although, the amount
of bleeding during surgeries is low, but taking
into account the limited environment of surgery
and limitation in visibility of surgery site by
endoscope, a small amount of bleeding can
interfere with visibility of surgeon, which will
lead to frequent use of suction and will increase
the risk of manipulation of field leading to more
bleeding and subsequently prolong duration of
surgery. Several methods have been utilized to
prevent bleeding during endoscopic surgeries
such as head elevation, bipolar diathermy,
packing, vasoconstrictor drugs, controlled hypo-
tensive anaesthesia and the use of intravenous
anaesthesia techniques2. One of the popular
methods to deal with hemorrhage is to admi-
nister antifibrinolytic agent such as tranexamic
acid. Tranexamic acid is an anti-fibrin synthetic
agent that binds to the lysine binding sites of
plasminogen and plasmin. After saturation of
binding sites the parting of plasminogen from
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which
permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Correspondence: Dr Tarique Ahmed Maka, ENT Department,
CMH Risalpur, Pakistan (Email: tariqmaka@yahoo.com)
Received: 09 Apr 2019; revised received: 19 Aug 2018; accepted: 26 Aug
2019
Original ArticleOpen Access
Tranexamic Acid in Endoscopic Sinus Surgery Pak Armed Forces Med J 2020; 70 (1): 17-21
18
fibrous fibrillation takes place and thus prevent
fibrinolysis. Any tissue injury can activate enzy-
mes release such as tissue plasminogen activator
that will convert plasminogen to plasmin and
activate fibrinolysis process. Tranexamic acid
can inhibit fibrin degradation by impeding the
activity of this enzyme3. Tranexamic acid pre-
vents plasminogen linking with fibrin to make
plasmin and thus stabilizes the formed clot4. A
study conducted in Tehran, Iran in 2015 showed
that there was significantly lesser blood loss
in tranexamic acid cases as compared to the
placebo5. The rationale of study was to assess the
haemostatic role of tranexamic acid versus
placebo in endoscopic sinus surgery.
METHODOLOGY
It was quasi experiment study conducted at
department of ENT and Head & Neck Surgery,
Combined Military Hospital Peshawar, from
January 2017 to December 2017, with prior per-
mission from hospital ethical review committee.
The sample size was calculated using WHO
sample size calculator. By keeping significance
level 0.05, power of test 80%, unexposed popu-
lation proportion 35% and anticipated population
proportion 14%, a sample size of n=130 (65 in
each group) was calculated5. Non-probability,
consecutive sampling was applied for selection
of all the patients. Cases of both gender, ranging
between the ages 18-50 years suffering from
bilateral ethmoidal paranasal polyps, chronic
rhinosinusitis who were unsuccessful from medi-
cal treatment and having no previous history of
sinonasal surgery that complied were included in
the research.
Patients having anemia, bleeding diathesis,
ongoing anticoagulant therapy, thrombotic
events history, myocardial ischemia, cerebro-
vascular thrombosis, diabetic and hypertensive,
or unfit for general anesthesia were excluded
from our research.
Sample population was recruited from
ENT department, Combined Military Hospital
Peshawar. After taking informed consent,
detailed ENT examination was carried out to
select the sample. All patients being worked up
for Functional Endoscopic Sinus Surgery under-
went full examination before surgery, details
of fibreoptic nasal examination were recorded
and imaging involving computed tomography of
paranasal sinuses preoperatively was reported by
a radiologist. Patients were divided into 2 groups
by lottery method. In case group tranexamic acid
15mg/ kg body weight in 100 ml of normal saline
and in the control group 100 ml of normal saline
only in identical syringes were used 15 minutes
before start of surgery. At the end of surgery
intraoperative hemorrhage was estimated by
estimating for blood volume loss based on the
contents of suction container after subtracting the
irrigation fluid and the nasopharyngeal packing
measurement via electronic scale (1ml of blood
weighs 1 gram).
The SPSS version 17 was used for analyzing
data. Descriptive statistics were calculated for all
variables. Quantitative variables were analyzed
as mean ± standard deviation. Qualitative vari-
ables were summarized as percentages and freq-
uencies. Effect modifiers like age & gender were
addressed through stratification. Post stratifi-
cation Independent t-test was applied to link the
variance between the two groups. A p-value ≤0.05
was considered statistically significant.
RESULTS
The mean age in case group was 32.0 ± 6.29
years whereas 31.78 ± 6.59 in the control group.
The difference was insignificant (p=0.197) bet-
ween both groups. Age distribution of the cases
displayed that 30 (46.15%) in case group and 37
(56.92%) in control group were between 18-30
years of age whereas 35 (53.85%) in case group
and 28 (43.08%) in control group were between
31-50 years of age (table-I).
Gender distribution showed 34 (52.31%) in
case group and 29 (44.62%) in control group
were male while 31 (47.69%) in case group and 36
(55.38%) in control group were females (table-I).
The mean blood loss in case group was
104.15 ± 3.44 ml whereas in control group it was
184.32 ± 10.14 ml. The mean blood loss was
Tranexamic Acid in Endoscopic Sinus Surgery Pak Armed Forces Med J 2020; 70 (1): 17-21
19
significantly lower (p<0.001) in case group as
compared to the control (table-II).
The effect modifiers like age & gender
were addressed through stratification. Post
stratification t-test was applied (table-III & IV).
DISCUSSION
Endoscopic sinus surgery (ESS) is regularly
performed technique by ENT specialists due
to the high success rate, low complication and
improvements in imaging devices, and computer
assisted surgical intervention5. However, bleed-
ing during and after ESS is a problem that
concerns surgeons and reducing bleeding is a
significant challenge. Previous studies establis-
hed the satisfactory results of tranexamic acid, on
hemorrhage propensity in patients go through
surgery6,7,8.
We planned this study to estimate the result
of tranexamic acid on amount of blood volume
loss in patients during endoscopic sinus surgery.
We compared our data with a previous
research conducted in Tehran, Iran in 2015
showed that there was considerably lesser blood
volume in tranexamic acid group as compare to
in the placebo group (107.7 ± 45.1 Vs 189.3 ±
51ml)5. Our results are comparable with the
above study.
Eldaba et al evaluated the result of tranexa-
mic acid on the hemorrhage during the endo-
scopic paranasal sinus surgical procedure but this
study was conducted in children population6.
They recorded that solo dose of tranexamic acid
intra venous in children during the endoscopic
sinus surgery much clears excellence of surgical
field, lessens bleeding per operative, and extent
of surgical procedure.
Das et al evaluated the efficacy of single pre-
operative bolus dose of tranexamic acid on blood
volume loss deterrence, red blood cell transfusion
in patients undergoing head and neck cancer
surgery and concluded that tranexamic consider-
ably lessens blood loss and chances of colloid,
Table-I: Age and gender distribution (n=130).
Parameter
Case group (n=65) Control group (n=65)
Cases Percentage Cases Percentage
Age
(years)
18-30 30 46.15 37 56.92
31-50 35 53.85 28 43.08
Total 65 100 65 100
Mean ± SD 32.0 ± 6.29 31.78 ± 6.59
Gender
Male 34 52.31 29 44.62
Female 31 47.69 36 55.38
Total 65 100 65 100
Table-II: Blood volume loss comparison (n=130).
Blood Volume loss
(ml)
Case group (n=65) Control group (n=65)
p-value
Mean ± SD Mean ± SD
104.15 ± 3.44 184.32 ± 10.14 0.001
Table-III: Stratification for blood loss with regards to age.
Blood loss (ml)
Age Group
(years)
Case group (n=65) Control group (n=65)
p-value
Mean ± SD Mean ± SD
18-30 104.23 ± 3.35 184.35 ± 10.38
<0.001
31-50 104.09 ± 3.56 184.29 ± 10.01
Table-IV: Stratification for blood loss with regards to gender.
Blood loss (ml)
Gender
Case group (n=65) Control group (n=65)
p-value
Mean ± SD Mean ± SD
Male 103.65 ± 3.26 183.79 ± 10.48
<0.001
Female 104.71 ± 3.60 184.75 ± 9.99
Tranexamic Acid in Endoscopic Sinus Surgery Pak Armed Forces Med J 2020; 70 (1): 17-21
20
blood, and crystalloid transfusion caused by head
and neck cancer surgery9.
Ker et al carried out a detailed analysis eval-
uating the result of tranexamic acid on trans-
fusion of blood, events of thromboembo-lism,
and mortality in post-operative patients10. They
revealed that out of 129 trials, carried out
between 1972 and 2011, total 10,488 patients were
included. Probability of receiving transfusion
of blood was reduced by using tranexamic acid
(confidence of 95% with interval 0.58 to 0.65;
p<0.001, risk ratio 0.62). This result persisted
as the analysis was restricted to trials using
satisfactory distribution concealment (0.68, 0.62
to 0.74; p<0.001). The result of tranexamic acid on
stroke (1.14, 0.65 to 2.00; p=0.65), pulmonary
embolism (0.61, 0.25 to 1.47; p=0.27), myocardial
infarction (0.68, 0.43 to 1.09; p=0.11) and DVT
(0.86, 0.53 to 1.39; p=0.54), were indeterminate.
The group using the tranexamic acid (0.61, 0.38
to 0.98; p=0.04) showed fewer deaths. Even
though the analysis was limited to trials using
satisfactory concealment there was significant
improbability (0.67, 0.33 to 1.34; p=0.25). Cumu-
lative meta-analysis showing that reliable evi-
dence that tranexamic acid reduces the need for
transfusion, has been available for over 10 years.
These findings support our results but no stroke,
pulmonary embolism, myocardial infarction and
deep vein thrombosis was recorded in our study
and these findings were similar for any mortality.
Alimian et al evaluated the results of trane-
xamic acid on blood volume loss and improves
quality of surgical field during endoscopic sinus
surgical procedure, they recorded that blood
volume loss in the tranexamic acid cases was
184 ± 64 mL as compare to the the placebo cases,
312 ± 75 mL on average (P b 0.01)11. The median
hemorrhage score in the tranexamic acid cases
was considerably lesser than the placebo cases
[2 (1-3) vs 2.5 (2-4); P b 0.0001]. The surgeons feel
pleased with the quality of surgical field in the
tranexamic acid cases as compare to the placebo
cases [median score: 4 (3-5) vs 3 (1-5), P b 0.001].
They concluded that tranexamic acid efficiently
lessens hemorrhage and improves the quality of
surgical field.
Some other former studies described that
intra-venous injection of tranexamic acid to
patients undergoing head & neck cancer surgery,
oral surgery, liver transplantation, cardiac sur-
gery and spine surgery reduced intra-operative
and post-operative hemorrhage12-18.
Finally, our data and other above mentioned
studies justify the hypothesis that the “use of
intravenous tranexamic acid helps in achieving
hemostasis and improving the surgical field
during endoscopic sinus surgery”. However,
some other multicenter trials are required to
validate our findings.
CONCLUSION
Systemic administration of tranexamic acid
could decrease blood loss and operative time
intraoperatively, increasing the satisfaction of
surgeons. It did not provoke intraoperative
hemodynamic changes, postoperative vomiting
or nausea and coagulation parameters abnorma-
lity. We concluded that preoperative intravenous
tranexamic acid significantly reduces operative
estimated blood volume loss when compared to
placebo in patients undergoing endoscopic para
nasal sinus surgical procedures.
CONFLICT OF INTEREST
This study has no conflict of interest to be
declared by any author.
REFERENCES
1. Miłoński J, Pietkiewicz P, Urbaniak J, Olszewski J. Unilateral
pathological lesions of paranasal sinuses removed by endo-
scopic surgery. Otolaryngol Pol 2014; 68(2): 83-88.
2. Sanjuan de Moreta G, Cardoso-López I, Poletti-Serafini D.
Centripetal endoscopic sinus surgery in chronic rhinosinusitis: a
6-year experience. Am J Rhinol Allergy 2014; 28(1): 349-52.
3. Katzung B. Basic and clinical pharmacology. Norwalk: Appleton
and Lange 30 Nov 2017.
4. Langille MA, Chiarella A, Côté DW, Mulholland G, Sowerby LJ,
Dziegielewski PT, et al. Intravenous tranexamic acid and intra-
operative visualization during functional endoscopic sinus
surgery: a double-blind randomized controlled trial. Int Forum
Allergy Rhinol 2013; 3(4): 315-8.
5. Nuhi S, Tabrizi AG, Zarkhah L, Ashrafi BR. Impact of intra-
venous tranexamic acid on hemorrhage during endoscopic sinus
surgery. Iran J Otorhinolaryngol 2015; 27(82): 349-54.
Tranexamic Acid in Endoscopic Sinus Surgery Pak Armed Forces Med J 2020; 70 (1): 17-21
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6. Eldaba AA, Amr YM, Albirmawy OA. Effects of tranexamic acid
during endoscopic sinsus surgery in children. Saudi J Anaesth
2013; 7(3): 229–33.
7. Ravesloot MJL, Lourijsen E, Avdeeva K, Pundir V, Fokkens W.
Tranexamic acid for the reduction of bleeding during functional
endoscopic sinus surgery. Cochrane Database Sys Rev 2017; 11:
CD012843.
8. Yaniv E, Shvero J, Hadar T. Hemostatic effect of tranexamic acid
in elective nasal surgery. Am J Rhinol 2006; 20(1): 227–39.
9. Das A, Chattopadhyay S, Mandal D, Chhaule S, Mitra T,
Mukherjee A, et al. Does the preoperative administration of
tranexamic acid reduce perioperative blood loss and transfusion
requirements after head neck cancer surgery? A randomized,
controlled trial. Anesth Essays Res 2015; 9(3): 384-90.
10. Ker K. Effect of tranexamic acid on surgical bleeding: systematic
review and cumulative meta-analysis. Br Med J 2012; 344(1):
e3054-60.
11. Alimian M, Mohseni M. The effect of intravenous tranexamic
acid on blood loss and surgical field quality during endoscopic
sinus surgery: A placebo-controlled clinical trial. J Clin Anesth
2011; 23(1): 611-15.
12. Tengborn L, Blombäck M, Berntorp E. Tranexamic acid--an old
drug still going strong and making a revival. Thromb Res 2015;
135(2): 231-42.
13. Li G, Sun TW, Luo G, Zhang C. Efficacy of antifibrinolytic
agents on surgical bleeding and transfusion requirements in
spine surgery: a meta-analysis. Eur Spine J 2017; 26(1): 140-54.
14. Zaman SU, Zakir I, Faraz Q, Akhtar S, Nawaz A, Adeel M. Effect
of single-dose intravenous tranexamic acid on postoperative
nasal bleed in septoplasty. Eur Ann Otorhinolaryngol Head
Neck Dis 2019; 19(1): S1879-7296.
15. Qayum M, Ali W, Waheed N. Post partum hemorrhage pre-
vention with tranexamic acid is effective and safe in comparison
to placebo. Pak Armed Forces Med J 2018; 68(4): 908-13.
16. Butt M. Liver transplantation services in pakistan army. Pak
Armed Forces Med J 2018; 68(4): 685-86.
17. Ralley FE, Berta D, Binns V, Howard J, Naudie DD. One intra-
operative dose of tranexamic Acid for patients having primary
hip or knee arthroplasty. Clin Orthop Relat Res 2010; 468(1):
1905-11.
18. Brum MR, Miura MS, Castro SF, Machado GM, Lima LH.
Tranexamic acid in adenotonsillectomy in children: a double-
blind randomized clinical trial. Int J Pediatr Otorhinolaryngol
2012; 76(1): 1401–505.

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Tranexamic Acid Reduces Bleeding in Sinus Surgery

  • 1. Tranexamic Acid in Endoscopic Sinus Surgery Pak Armed Forces Med J 2020; 70 (1): 17-21 17 HHAAEEMMOOSSTTAATTIICC RROOLLEE OOFF TTRRAANNEEXXAAMMIICC AACCIIDD IINN EENNDDOOSSCCOOPPIICC SSIINNUUSS SSUURRGGEERRYY –– AANN IINNTTEERRVVEENNTTIIOONNAALL SSTTUUDDYY Farhan Halim, Zaheer Ul Hassan*, Tarique Ahmed Maka**, Kinza Shakil, Adnan Halim***, Aliya Halim*** Combined Military Hospital, Bannu Pakistan, *Combined Military Hospital, Peshawar Pakistan, **Combined Military Hospital, Risalpur Pakistan, ***Pak Emirates Military Hospital/National University of Medical Sciences (NUMS) Rawalpindi Pakistan ABSTRACT Objective: To compare preoperative intravenous tranexamic acid with placebo in terms of operative estimated blood loss, in patients undergoing endoscopic sinus surgery. Study Design: Quasi experimental study. Place and Duration of Study: Department of ENT, CMH Peshawar, from Jan 2017 to Jun 2017. Methodology: Patients were divided into 2 groups by lottery method. The case group received intravenous tranexamic acid 15mg/kg body weight in 100 ml of normal saline and the control group received 100 ml of normal saline only in identical syringes 15 minutes before start of surgery. At the end of surgery intraoperative hemorrhage was estimated by estimating for blood loss based on the contents of suction container after subtracting the irrigation fluid and the nasopharyngeal packing measurement via electronic scale (1ml of blood weighs 1 gram). Results: In our study, 30 (46.15%) in case group and 37 (56.92%) in control group were between the age of 18-30 years whereas 35 (53.85%) in case group and 28 (43.08%) in control group were between the age of 31-50 years. Mean ± SD was calculated as 32.0 ± 6.29 in case group and 31.78 ± 6.59 years in control group, 34 (52.31%) in case group and 29 (44.62%) in control group were males while 31 (47.69%) in case group and 36 (55.38%) in control group were females. Evaluation of mean blood loss in both groups was done, it shows 104.15 ± 3.44 ml in case group and 184.32 ±10.14 ml in control group, p-value was 0.0001. Conclusion: We concluded that preoperative intravenous tranexamic acid significantly reduces operative estimated blood volume loss when compared to placebo in patients undergoing endoscopic para nasal sinus surgical procedures. Keywords: Endoscopic paranasal sinus surgery, preoperative intravenous tranexamic acid, estimated peri- operative blood volume loss. INTRODUCTION Endoscopic sinus surgery is one of the modern technique of removing pathological lesions of the nasal cavity and paranasal sinuses including nasal polyposis and sinusitis. The pro- cedure is preferred over conventional nasal sur- gery due to its higher success rate and lesser chances of complications1. Bleeding during surgery is a common inevitable complication and a cause of major concern. Although, the amount of bleeding during surgeries is low, but taking into account the limited environment of surgery and limitation in visibility of surgery site by endoscope, a small amount of bleeding can interfere with visibility of surgeon, which will lead to frequent use of suction and will increase the risk of manipulation of field leading to more bleeding and subsequently prolong duration of surgery. Several methods have been utilized to prevent bleeding during endoscopic surgeries such as head elevation, bipolar diathermy, packing, vasoconstrictor drugs, controlled hypo- tensive anaesthesia and the use of intravenous anaesthesia techniques2. One of the popular methods to deal with hemorrhage is to admi- nister antifibrinolytic agent such as tranexamic acid. Tranexamic acid is an anti-fibrin synthetic agent that binds to the lysine binding sites of plasminogen and plasmin. After saturation of binding sites the parting of plasminogen from This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Correspondence: Dr Tarique Ahmed Maka, ENT Department, CMH Risalpur, Pakistan (Email: tariqmaka@yahoo.com) Received: 09 Apr 2019; revised received: 19 Aug 2018; accepted: 26 Aug 2019 Original ArticleOpen Access
  • 2. Tranexamic Acid in Endoscopic Sinus Surgery Pak Armed Forces Med J 2020; 70 (1): 17-21 18 fibrous fibrillation takes place and thus prevent fibrinolysis. Any tissue injury can activate enzy- mes release such as tissue plasminogen activator that will convert plasminogen to plasmin and activate fibrinolysis process. Tranexamic acid can inhibit fibrin degradation by impeding the activity of this enzyme3. Tranexamic acid pre- vents plasminogen linking with fibrin to make plasmin and thus stabilizes the formed clot4. A study conducted in Tehran, Iran in 2015 showed that there was significantly lesser blood loss in tranexamic acid cases as compared to the placebo5. The rationale of study was to assess the haemostatic role of tranexamic acid versus placebo in endoscopic sinus surgery. METHODOLOGY It was quasi experiment study conducted at department of ENT and Head & Neck Surgery, Combined Military Hospital Peshawar, from January 2017 to December 2017, with prior per- mission from hospital ethical review committee. The sample size was calculated using WHO sample size calculator. By keeping significance level 0.05, power of test 80%, unexposed popu- lation proportion 35% and anticipated population proportion 14%, a sample size of n=130 (65 in each group) was calculated5. Non-probability, consecutive sampling was applied for selection of all the patients. Cases of both gender, ranging between the ages 18-50 years suffering from bilateral ethmoidal paranasal polyps, chronic rhinosinusitis who were unsuccessful from medi- cal treatment and having no previous history of sinonasal surgery that complied were included in the research. Patients having anemia, bleeding diathesis, ongoing anticoagulant therapy, thrombotic events history, myocardial ischemia, cerebro- vascular thrombosis, diabetic and hypertensive, or unfit for general anesthesia were excluded from our research. Sample population was recruited from ENT department, Combined Military Hospital Peshawar. After taking informed consent, detailed ENT examination was carried out to select the sample. All patients being worked up for Functional Endoscopic Sinus Surgery under- went full examination before surgery, details of fibreoptic nasal examination were recorded and imaging involving computed tomography of paranasal sinuses preoperatively was reported by a radiologist. Patients were divided into 2 groups by lottery method. In case group tranexamic acid 15mg/ kg body weight in 100 ml of normal saline and in the control group 100 ml of normal saline only in identical syringes were used 15 minutes before start of surgery. At the end of surgery intraoperative hemorrhage was estimated by estimating for blood volume loss based on the contents of suction container after subtracting the irrigation fluid and the nasopharyngeal packing measurement via electronic scale (1ml of blood weighs 1 gram). The SPSS version 17 was used for analyzing data. Descriptive statistics were calculated for all variables. Quantitative variables were analyzed as mean ± standard deviation. Qualitative vari- ables were summarized as percentages and freq- uencies. Effect modifiers like age & gender were addressed through stratification. Post stratifi- cation Independent t-test was applied to link the variance between the two groups. A p-value ≤0.05 was considered statistically significant. RESULTS The mean age in case group was 32.0 ± 6.29 years whereas 31.78 ± 6.59 in the control group. The difference was insignificant (p=0.197) bet- ween both groups. Age distribution of the cases displayed that 30 (46.15%) in case group and 37 (56.92%) in control group were between 18-30 years of age whereas 35 (53.85%) in case group and 28 (43.08%) in control group were between 31-50 years of age (table-I). Gender distribution showed 34 (52.31%) in case group and 29 (44.62%) in control group were male while 31 (47.69%) in case group and 36 (55.38%) in control group were females (table-I). The mean blood loss in case group was 104.15 ± 3.44 ml whereas in control group it was 184.32 ± 10.14 ml. The mean blood loss was
  • 3. Tranexamic Acid in Endoscopic Sinus Surgery Pak Armed Forces Med J 2020; 70 (1): 17-21 19 significantly lower (p<0.001) in case group as compared to the control (table-II). The effect modifiers like age & gender were addressed through stratification. Post stratification t-test was applied (table-III & IV). DISCUSSION Endoscopic sinus surgery (ESS) is regularly performed technique by ENT specialists due to the high success rate, low complication and improvements in imaging devices, and computer assisted surgical intervention5. However, bleed- ing during and after ESS is a problem that concerns surgeons and reducing bleeding is a significant challenge. Previous studies establis- hed the satisfactory results of tranexamic acid, on hemorrhage propensity in patients go through surgery6,7,8. We planned this study to estimate the result of tranexamic acid on amount of blood volume loss in patients during endoscopic sinus surgery. We compared our data with a previous research conducted in Tehran, Iran in 2015 showed that there was considerably lesser blood volume in tranexamic acid group as compare to in the placebo group (107.7 ± 45.1 Vs 189.3 ± 51ml)5. Our results are comparable with the above study. Eldaba et al evaluated the result of tranexa- mic acid on the hemorrhage during the endo- scopic paranasal sinus surgical procedure but this study was conducted in children population6. They recorded that solo dose of tranexamic acid intra venous in children during the endoscopic sinus surgery much clears excellence of surgical field, lessens bleeding per operative, and extent of surgical procedure. Das et al evaluated the efficacy of single pre- operative bolus dose of tranexamic acid on blood volume loss deterrence, red blood cell transfusion in patients undergoing head and neck cancer surgery and concluded that tranexamic consider- ably lessens blood loss and chances of colloid, Table-I: Age and gender distribution (n=130). Parameter Case group (n=65) Control group (n=65) Cases Percentage Cases Percentage Age (years) 18-30 30 46.15 37 56.92 31-50 35 53.85 28 43.08 Total 65 100 65 100 Mean ± SD 32.0 ± 6.29 31.78 ± 6.59 Gender Male 34 52.31 29 44.62 Female 31 47.69 36 55.38 Total 65 100 65 100 Table-II: Blood volume loss comparison (n=130). Blood Volume loss (ml) Case group (n=65) Control group (n=65) p-value Mean ± SD Mean ± SD 104.15 ± 3.44 184.32 ± 10.14 0.001 Table-III: Stratification for blood loss with regards to age. Blood loss (ml) Age Group (years) Case group (n=65) Control group (n=65) p-value Mean ± SD Mean ± SD 18-30 104.23 ± 3.35 184.35 ± 10.38 <0.001 31-50 104.09 ± 3.56 184.29 ± 10.01 Table-IV: Stratification for blood loss with regards to gender. Blood loss (ml) Gender Case group (n=65) Control group (n=65) p-value Mean ± SD Mean ± SD Male 103.65 ± 3.26 183.79 ± 10.48 <0.001 Female 104.71 ± 3.60 184.75 ± 9.99
  • 4. Tranexamic Acid in Endoscopic Sinus Surgery Pak Armed Forces Med J 2020; 70 (1): 17-21 20 blood, and crystalloid transfusion caused by head and neck cancer surgery9. Ker et al carried out a detailed analysis eval- uating the result of tranexamic acid on trans- fusion of blood, events of thromboembo-lism, and mortality in post-operative patients10. They revealed that out of 129 trials, carried out between 1972 and 2011, total 10,488 patients were included. Probability of receiving transfusion of blood was reduced by using tranexamic acid (confidence of 95% with interval 0.58 to 0.65; p<0.001, risk ratio 0.62). This result persisted as the analysis was restricted to trials using satisfactory distribution concealment (0.68, 0.62 to 0.74; p<0.001). The result of tranexamic acid on stroke (1.14, 0.65 to 2.00; p=0.65), pulmonary embolism (0.61, 0.25 to 1.47; p=0.27), myocardial infarction (0.68, 0.43 to 1.09; p=0.11) and DVT (0.86, 0.53 to 1.39; p=0.54), were indeterminate. The group using the tranexamic acid (0.61, 0.38 to 0.98; p=0.04) showed fewer deaths. Even though the analysis was limited to trials using satisfactory concealment there was significant improbability (0.67, 0.33 to 1.34; p=0.25). Cumu- lative meta-analysis showing that reliable evi- dence that tranexamic acid reduces the need for transfusion, has been available for over 10 years. These findings support our results but no stroke, pulmonary embolism, myocardial infarction and deep vein thrombosis was recorded in our study and these findings were similar for any mortality. Alimian et al evaluated the results of trane- xamic acid on blood volume loss and improves quality of surgical field during endoscopic sinus surgical procedure, they recorded that blood volume loss in the tranexamic acid cases was 184 ± 64 mL as compare to the the placebo cases, 312 ± 75 mL on average (P b 0.01)11. The median hemorrhage score in the tranexamic acid cases was considerably lesser than the placebo cases [2 (1-3) vs 2.5 (2-4); P b 0.0001]. The surgeons feel pleased with the quality of surgical field in the tranexamic acid cases as compare to the placebo cases [median score: 4 (3-5) vs 3 (1-5), P b 0.001]. They concluded that tranexamic acid efficiently lessens hemorrhage and improves the quality of surgical field. Some other former studies described that intra-venous injection of tranexamic acid to patients undergoing head & neck cancer surgery, oral surgery, liver transplantation, cardiac sur- gery and spine surgery reduced intra-operative and post-operative hemorrhage12-18. Finally, our data and other above mentioned studies justify the hypothesis that the “use of intravenous tranexamic acid helps in achieving hemostasis and improving the surgical field during endoscopic sinus surgery”. However, some other multicenter trials are required to validate our findings. CONCLUSION Systemic administration of tranexamic acid could decrease blood loss and operative time intraoperatively, increasing the satisfaction of surgeons. It did not provoke intraoperative hemodynamic changes, postoperative vomiting or nausea and coagulation parameters abnorma- lity. We concluded that preoperative intravenous tranexamic acid significantly reduces operative estimated blood volume loss when compared to placebo in patients undergoing endoscopic para nasal sinus surgical procedures. CONFLICT OF INTEREST This study has no conflict of interest to be declared by any author. REFERENCES 1. Miłoński J, Pietkiewicz P, Urbaniak J, Olszewski J. Unilateral pathological lesions of paranasal sinuses removed by endo- scopic surgery. Otolaryngol Pol 2014; 68(2): 83-88. 2. Sanjuan de Moreta G, Cardoso-López I, Poletti-Serafini D. Centripetal endoscopic sinus surgery in chronic rhinosinusitis: a 6-year experience. Am J Rhinol Allergy 2014; 28(1): 349-52. 3. Katzung B. Basic and clinical pharmacology. Norwalk: Appleton and Lange 30 Nov 2017. 4. Langille MA, Chiarella A, Côté DW, Mulholland G, Sowerby LJ, Dziegielewski PT, et al. Intravenous tranexamic acid and intra- operative visualization during functional endoscopic sinus surgery: a double-blind randomized controlled trial. Int Forum Allergy Rhinol 2013; 3(4): 315-8. 5. Nuhi S, Tabrizi AG, Zarkhah L, Ashrafi BR. Impact of intra- venous tranexamic acid on hemorrhage during endoscopic sinus surgery. Iran J Otorhinolaryngol 2015; 27(82): 349-54.
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