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Journal club
Intravenous and Topical
Tranexamic Acid Alone Are
Superior to Tourniquet Use for
Primary Total Knee Arthroplasty
A Prospective, Randomized
Controlled Trial
ZeYu Huang, MD, PhD*, XiaoWei Xie, MD*, LingLi Li, MNS*, Qiang Huang, MD,
Jun Ma, MD, Bin Shen, MD, PhD, Virginia Byers Kraus, MD, PhD, and FuXing Pei,
MD
-Dr Shalabh Kumar
senior resident
AIIMS (R)
• Level 1 Randomized controlled trial
• Performed at the Department of Orthopedic
Surgery, West China Hospital, West China
Medical School, Sichuan University, ChengDu,
Sichuan Province, People’s Republic of China
• June 2015 to december 2015
Hypothesis
• They hypothesized that tourniquet use is not
necessary when intravenous and topical TXA is
utilized in primary total knee arthroplasty
What is tranexamic acid ?
• Tranexamic acid is an antifibrinolytic agent
- It competitively inhibits activation of plasminogen
thereby reducing conversion of plasminogen to
plasmin (fibrinolysin), an enzyme that degrades fibrin
clots, fibrinogen, and other plasma proteins,
including the procoagulant factors V and VIII.
• It also directly inhibits plasmin activity, but higher
doses are required than are needed to reduce
plasmin formation.
What is tourniquet ?
• Constricting or compressing device used to control
venous and arterial circulation to an extremity for a
period of time.
• Pressureis appliedcircumferentiallyupon the skin underlying
tissues of thelimb
• Pressureis transferred to the
vesselwalls, occludingthem
• Pressure of 135 to 255 mm Hg for upper limbs
• 175 to 305 mm Hg for lower extrimities
• Wide cuffs are more effective at lower
pressure
• 10 cm width in arm & 15 cm in thigh
• Curved tourniquets for conical extrimities
• Perioperative blood loss - one of the major
complications
• Can exceed 1,000 mL, or approximately 20% of the
body’s total blood volume.
• As a routine practice, surgeons apply a tourniquet
during total knee arthroplasty to reduce blood loss and
improve surgical field visualization.
• Disadvantages -
– reduced early knee flexion
– increased perioperative pain
– increased postoperative limb swelling
– frequent wound complications.
• Asymptomatic pulmonary embolism within
one minute of tourniquet release
• Tournquet paralysis
• Compartment syndrome
• Rhabdomylosis
• Post tourniquet syndrome
Materials and Methods
• Randomized control study
• INCLUSIONS
-All patients 18 years of age or older who were
scheduled for a primary total knee
arthroplasty for end-stage osteoarthritis were
eligible for inclusion
• EXCLUSIONS
- revision procedures
- bilateral procedures
- previous knee surgery
- flexion deformity of 30 degree or more
- varus-valgus deformity of 30 degree or more
- anemia (hemoglobin [Hb] level of <12 g/dL for
women and <13 g/dL for men)
- contraindications for the use of TXA (h/o
blood clot events within 6 months)
- Coagulation disorder
- ASA grade IV
Patients randomized into 3 groups;
Group A
tourniquet + i.v tranexamic acid (20mg/kg)
5-10 min before skin incision
1 gm of topical in 50 ml NS
10mg/kg, 3,6,12,24 hrs later
Group B
iv tranexamic acid only (same doses)
Group C
tourniquet only
In Groups A and C, the tourniquet was inflated
to 100 mm Hg above systolic pressure before the
incision and deflated after closure of the incision
Surgical procedure
• under general anesthesia, by 1 surgical team
composed of 2 senior orthopaedic surgeons.
• The operations were done in the standard way, using a
midline skin incision, a standard medial parapatellar
approach, and a measured resection technique.
• Vaccum wound drainage
• No blood salvage system was used; electrocautery and
routine hemostasis were performed during the surgery.
• Surgical time, intraoperative blood loss, and drainage
volume were recorded
• Postoperatively- anesthesia recovery unit for 1
hour, and then to the inpatient unit
• Cold pack for 12 hours
• Intraoperative periarticular injection of
ropivacaine
• Postoperative oral diclofenac sodium (Voltaren;
50 mg twice daily) were administered for pain on
the day of the surgery and 3 times daily
thereafter until hospital discharge
• Physical therapist for all
• Began walking with partial weight-bearing and
wearing a knee brace to protect the surgical
site.
• Mechanical and chemical DVT prophylaxis
• Doppler ultrasound was used to evaluate for
DVT at the time of discharge and at 1, 3, and
6-month follow-up evaluations, or at any time
that DVT was clinically suspected.
• Criteria for transfusion included
-symptomatic anemia
- in a patient with an Hb level of 7 to 10 g/dL
- Hb level of <7 g/dL regardless of
accompanying symptoms
Outcome measurements
• Data on patient demographics, medical
history, concomitant medications, length of
hospital stay, and any complications were
collected along with a complete blood-cell
count, hepatic function, blood creatinine level,
blood urea nitrogen (BUN) level, prothrombin
time (PT), activated partial thromboplastin
time (aPTT), and platelet count during the
inpatient hospitalization and at 1week and
1,3,and 6 months postoperatively.
• The complete blood-cell count and levels of
inflammatory markers (C-reactive protein
[CRP] and interleukin-6 [IL-6]) were tested on
postoperative days 1, 2, 3, and 5.
Statical analysis
• Quantitative data
– Applied ANOVA and Tukey post hoc test
• Qualitative data
– Pearson chi square test
– Fischer exact test
Results
• Blood loss
Results
- Pain
• Inflammatory markers
• Patient Satisfaction
At the time of discharge, patients in Group B
had significantly higher satisfaction ratings
than both Groups A and C (100% at least
somewhat satisfied compared with 96% [p =
0.035] and 72% [p < 0.001], respectively)
(Table III).
• At the 6-month follow-up evaluation, there
were no significant differences in satisfaction
among the 3 groups
Complications
• DVT or PE
Neither of them occurred in any patient.
Postoperatively, routine Doppler ultrasound
showed that 13 patients (6 from Group A, 4
from Group B, and 3 from Group C) developed
intramuscular venous thrombosis. The
differences among the groups were not
significant (p = 0.672).
Infection
One patient from Group A and 3 patients
from Group C developed superficial infection,
which was controlled with dressing changes
and oral antibiotics.
Wound secretion
occurred in 15 patients (6 from Group A and
9 from Group C). No wound secretion was
observed in Group B during the entire follow-
up period, and this represented a significant
difference compared with Group
A(p=0.027)andGroupC(p=0.003).
Blistering
was reported in 3 patients from Group C and
no patients in Group A or B.
LIMITATIONS
• short follow-up
• prosthetic fixation and survival outcomes
were outside the scope of this study
• although this study showed a low frequency
of DVT, PE, and other complications, a larger
sample size would be needed to adequately
evaluate for significant group differences in
these adverse events
TAKE HOME MASSAGE
• Tranexamic acid decreases blood loss and post
operative morbidity
• Proper use of tourniquet in respect of time
and pressure

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JOURNAL CLUB ON TOTAL KNEE ARTHROPLASTY

  • 1. Journal club Intravenous and Topical Tranexamic Acid Alone Are Superior to Tourniquet Use for Primary Total Knee Arthroplasty A Prospective, Randomized Controlled Trial ZeYu Huang, MD, PhD*, XiaoWei Xie, MD*, LingLi Li, MNS*, Qiang Huang, MD, Jun Ma, MD, Bin Shen, MD, PhD, Virginia Byers Kraus, MD, PhD, and FuXing Pei, MD -Dr Shalabh Kumar senior resident AIIMS (R)
  • 2. • Level 1 Randomized controlled trial • Performed at the Department of Orthopedic Surgery, West China Hospital, West China Medical School, Sichuan University, ChengDu, Sichuan Province, People’s Republic of China • June 2015 to december 2015
  • 3. Hypothesis • They hypothesized that tourniquet use is not necessary when intravenous and topical TXA is utilized in primary total knee arthroplasty
  • 4.
  • 5.
  • 6. What is tranexamic acid ? • Tranexamic acid is an antifibrinolytic agent - It competitively inhibits activation of plasminogen thereby reducing conversion of plasminogen to plasmin (fibrinolysin), an enzyme that degrades fibrin clots, fibrinogen, and other plasma proteins, including the procoagulant factors V and VIII. • It also directly inhibits plasmin activity, but higher doses are required than are needed to reduce plasmin formation.
  • 7. What is tourniquet ? • Constricting or compressing device used to control venous and arterial circulation to an extremity for a period of time. • Pressureis appliedcircumferentiallyupon the skin underlying tissues of thelimb • Pressureis transferred to the vesselwalls, occludingthem
  • 8. • Pressure of 135 to 255 mm Hg for upper limbs • 175 to 305 mm Hg for lower extrimities • Wide cuffs are more effective at lower pressure • 10 cm width in arm & 15 cm in thigh • Curved tourniquets for conical extrimities
  • 9. • Perioperative blood loss - one of the major complications • Can exceed 1,000 mL, or approximately 20% of the body’s total blood volume. • As a routine practice, surgeons apply a tourniquet during total knee arthroplasty to reduce blood loss and improve surgical field visualization. • Disadvantages - – reduced early knee flexion – increased perioperative pain – increased postoperative limb swelling – frequent wound complications.
  • 10. • Asymptomatic pulmonary embolism within one minute of tourniquet release • Tournquet paralysis • Compartment syndrome • Rhabdomylosis • Post tourniquet syndrome
  • 11. Materials and Methods • Randomized control study • INCLUSIONS -All patients 18 years of age or older who were scheduled for a primary total knee arthroplasty for end-stage osteoarthritis were eligible for inclusion
  • 12. • EXCLUSIONS - revision procedures - bilateral procedures - previous knee surgery - flexion deformity of 30 degree or more - varus-valgus deformity of 30 degree or more - anemia (hemoglobin [Hb] level of <12 g/dL for women and <13 g/dL for men) - contraindications for the use of TXA (h/o blood clot events within 6 months) - Coagulation disorder - ASA grade IV
  • 13.
  • 14. Patients randomized into 3 groups; Group A tourniquet + i.v tranexamic acid (20mg/kg) 5-10 min before skin incision 1 gm of topical in 50 ml NS 10mg/kg, 3,6,12,24 hrs later Group B iv tranexamic acid only (same doses)
  • 15. Group C tourniquet only In Groups A and C, the tourniquet was inflated to 100 mm Hg above systolic pressure before the incision and deflated after closure of the incision
  • 17. • under general anesthesia, by 1 surgical team composed of 2 senior orthopaedic surgeons. • The operations were done in the standard way, using a midline skin incision, a standard medial parapatellar approach, and a measured resection technique. • Vaccum wound drainage • No blood salvage system was used; electrocautery and routine hemostasis were performed during the surgery. • Surgical time, intraoperative blood loss, and drainage volume were recorded
  • 18. • Postoperatively- anesthesia recovery unit for 1 hour, and then to the inpatient unit • Cold pack for 12 hours • Intraoperative periarticular injection of ropivacaine • Postoperative oral diclofenac sodium (Voltaren; 50 mg twice daily) were administered for pain on the day of the surgery and 3 times daily thereafter until hospital discharge
  • 19. • Physical therapist for all • Began walking with partial weight-bearing and wearing a knee brace to protect the surgical site. • Mechanical and chemical DVT prophylaxis
  • 20. • Doppler ultrasound was used to evaluate for DVT at the time of discharge and at 1, 3, and 6-month follow-up evaluations, or at any time that DVT was clinically suspected. • Criteria for transfusion included -symptomatic anemia - in a patient with an Hb level of 7 to 10 g/dL - Hb level of <7 g/dL regardless of accompanying symptoms
  • 21.
  • 22. Outcome measurements • Data on patient demographics, medical history, concomitant medications, length of hospital stay, and any complications were collected along with a complete blood-cell count, hepatic function, blood creatinine level, blood urea nitrogen (BUN) level, prothrombin time (PT), activated partial thromboplastin time (aPTT), and platelet count during the inpatient hospitalization and at 1week and 1,3,and 6 months postoperatively.
  • 23. • The complete blood-cell count and levels of inflammatory markers (C-reactive protein [CRP] and interleukin-6 [IL-6]) were tested on postoperative days 1, 2, 3, and 5.
  • 24. Statical analysis • Quantitative data – Applied ANOVA and Tukey post hoc test • Qualitative data – Pearson chi square test – Fischer exact test
  • 25.
  • 29. • Patient Satisfaction At the time of discharge, patients in Group B had significantly higher satisfaction ratings than both Groups A and C (100% at least somewhat satisfied compared with 96% [p = 0.035] and 72% [p < 0.001], respectively) (Table III). • At the 6-month follow-up evaluation, there were no significant differences in satisfaction among the 3 groups
  • 30. Complications • DVT or PE Neither of them occurred in any patient. Postoperatively, routine Doppler ultrasound showed that 13 patients (6 from Group A, 4 from Group B, and 3 from Group C) developed intramuscular venous thrombosis. The differences among the groups were not significant (p = 0.672).
  • 31. Infection One patient from Group A and 3 patients from Group C developed superficial infection, which was controlled with dressing changes and oral antibiotics.
  • 32. Wound secretion occurred in 15 patients (6 from Group A and 9 from Group C). No wound secretion was observed in Group B during the entire follow- up period, and this represented a significant difference compared with Group A(p=0.027)andGroupC(p=0.003). Blistering was reported in 3 patients from Group C and no patients in Group A or B.
  • 33. LIMITATIONS • short follow-up • prosthetic fixation and survival outcomes were outside the scope of this study • although this study showed a low frequency of DVT, PE, and other complications, a larger sample size would be needed to adequately evaluate for significant group differences in these adverse events
  • 34. TAKE HOME MASSAGE • Tranexamic acid decreases blood loss and post operative morbidity • Proper use of tourniquet in respect of time and pressure