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The latest on Tranexamic Acid TXA
The document evaluates the efficacy of tranexamic acid (TXA) for various bleeding conditions, providing insights from studies such as the Crash-2 trial and several meta-analyses. Key findings suggest TXA is beneficial for trauma and gastrointestinal bleeding, while its use in intracranial hemorrhage and postpartum hemorrhage shows minimal patient-oriented benefits. The document concludes with an outline of recommended dosing and indicates scenarios where TXA usage is applicable.
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The latest on Tranexamic Acid TXA
- 1. Tranexamic Acid (TXA)for Everything That Bleeds? Salim R. Rezaie, MD @srrezaie
- 2. Trauma MATTERs 2012 &CRASH-2 2010
- 3. Trauma MATTERs 2012 Overall 48hrMort = NNT 13 Overall 30d Mort = NNT 15
- 4. Trauma MATTERs 2012 Overall48hr Mort = NNT 13 Overall 30d Mort = NNT 15 MTP 48hr Mort NNT = 8 MTP 30d Mort NNT = 7
- 5. Trauma CRASH-2 2010 Overall48hr Mort = NNT 13 Overall 30d Mort = NNT 15 MTP 48hr Mort NNT = 8 MTP 30d Mort NNT = 7 Overall Mort NNT = 67
- 6. Trauma Bottom Line Trauma≤3hr + Thinking MTP TXA 1g over 10min + TXA 1g over 8hrs
- 7. Intracranial Hemorrhage (ICH) 2014Meta-Analysis & TICH-2 2018
- 8. Intracranial Hemorrhage (ICH) 2014Meta-Analysis & TICH-2 2018 No Difference Mortality at 90d Neuro Function at 90d Hematoma Expansion at 48hrs
- 9. Intracranial Hemorrhage (ICH) 2014Meta-Analysis & TICH-2 2018 No Difference Mortality at 90d Neuro Function at 90d Hematoma Expansion at 48hrs Hypothesis Generating Hematoma Expansion at 24hrs Mortality at 7d
- 10. ICH Bottom Line TXANot Recommended No Patient Oriented Benefits
- 11.
- 12. Post-Partum Hemorrhage (PPH) WOMANTrial 2017
- 13. Post-Partum Hemorrhage (PPH) WOMANTrial 2017 Death Due to PPH NNT ≈250
- 14. Post-Partum Hemorrhage (PPH) WOMANTrial 2017 Death Due to PPH NNT ≈250 Death Due to PPH if TXA ≤3hr NNT ≈200
- 15. Post-Partum Hemorrhage (PPH) WOMANTrial 2017 Death Due to PPH NNT ≈250 Death Due to PPH if TXA ≤3hr NNT ≈200 Fragility Index = 0
- 16. PPH Bottom Line TXAMay or May Not Benefit TXA 1g IV
- 17. Gastrointestinal Bleed (GIB) CochraneMeta-Analysis 2014
- 18. Gastrointestinal Bleed (GIB) CochraneMeta-Analysis 2014 8 Trials (1700 pts)
- 19. Gastrointestinal Bleed (GIB) CochraneMeta-Analysis 2014 8 Trials (1700 pts) Mortality NNT = 29
- 20. Gastrointestinal Bleed (GIB) CochraneMeta-Analysis 2014 8 Trials (1700 pts) Mortality NNT = 29 Small Trials
- 21. Upper GIB BottomLine TXA Reduced Mortality ?? Reduced Rebleeding Use Only in Sickest Pts Optimal Dosing Unclear
- 22.
- 23.
- 24. Epistaxis Zahed et al2017 124pts on ASA &/or Plavix
- 25. Epistaxis Zahed et al2017 124pts on ASA &/or Plavix No Bleeding at 10min NNT = 2
- 26. Epistaxis Zahed et al2017 124pts on ASA &/or Plavix No Bleeding at 10min NNT = 2 Decreased LOS
- 27. Epistaxis Bottom Line TopicalTXA Decreases Bleeding 500mg TXA Soaked Pledget
- 28. Post-Tonsillectomy Bleeding Meta-Analysis 2012& 1 Case Report 2019
- 29. Post-Tonsillectomy Bleeding Meta-Analysis 2012 OnlyStudies of Prophylactic Effects
- 30. Post-Tonsillectomy Bleeding Meta-Analysis 2012& 1 Case Report 2019 Only Studies of Prophylactic Effects Case Report of Nebulized TXA
- 31. Post-Tonsillectomy Bottom Line Only1 Case Report of Nebulized TXA Nebulized TXA: 250mg in <25kg 500mg in ≥25kg
- 32. Hemoptysis Case Series 2018& RCT 2018
- 33. Hemoptysis Case Series 2018 Resolutionof 50% at <30min
- 34. Hemoptysis RCT 2018 Resolution of50% at <30min RCT NNT = 2 BUT 5d Outcomes
- 35. Hemoptysis Bottom Line 14Cases & 1 RCT Nebulized TXA: 250mg in <25kg 500mg in ≥25kg RCT Evaluated 5d Outcomes
- 36. Nebulized Tranexamic Acid(TXA) TXA -> Nebulizer Nebulized Dosing Options 250mg (<25kg) 500 - 1000mg (≥25kg)
- 37. Tranexamic Acid (TXA)for Everything That Bleeds? TXA Use Yes or No Trauma ≤3hrs + Thinking MTP YES ICH NO PPH +/- GIB +/- Epistaxis YES Post-Tonsillectomy YES Hemoptysis YES
- 38. Tranexamic Acid (TXA)for Everything That Bleeds? TXA Use Yes or No Dosing Trauma ≤3hrs + Thinking MTP YES 1g IV over 10min + 1g IV over 8hr ICH NO --- PPH +/- 1g IV over 10min GIB +/- ??? Epistaxis YES 500mg Soaked Pledget Post-Tonsillectomy YES 250mg Nebulized (<25kg) OR 500 - 1000mg Nebulized (≥25kg) Hemoptysis YES 250mg Nebulized (<25kg) OR 500 - 1000mg Nebulized (≥25kg)
- 39. Thank You Salim R.Rezaie, MD @srrezaie
Editor's Notes
- #2 What’s the latest on TXA for trauma, post-partum hemorrhage (WOMAN), epistaxis, dental bleeding GI bleed, dialysis access points, ICH (TICH2) - 10 – 12min
- #3 MATTERs single center retrospective observational study ≈800pts Primary Outcome: 24hr mortality, 48hr mortality and 30d mortality No difference in 24hr mortality Overall 48hr mortality NNT = 13 Overall 30d Mortality NNT = 15 Massive Transfusion 48hr Mortality NNT = 8 Massive Transfusion 30d Mortality NNT = 7 CRASH-2 multicenter, double-blind, randomized, placebo controlled trial of ≈20k pts Primary Outcome was All-Cause 4week Mortality All-Cause Mortality NNT = 67 No Increase in VTE in Either Study
- #4 MATTERs single center retrospective observational study ≈800pts Primary Outcome: 24hr mortality, 48hr mortality and 30d mortality No difference in 24hr mortality Overall 48hr mortality NNT = 13 Overall 30d Mortality NNT = 15 Massive Transfusion 48hr Mortality NNT = 8 Massive Transfusion 30d Mortality NNT = 7 CRASH-2 multicenter, double-blind, randomized, placebo controlled trial of ≈20k pts Primary Outcome was All-Cause 4week Mortality All-Cause Mortality NNT = 67 No Increase in VTE in Either Study
- #5 MATTERs single center retrospective observational study ≈800pts Primary Outcome: 24hr mortality, 48hr mortality and 30d mortality No difference in 24hr mortality Overall 48hr mortality NNT = 13 Overall 30d Mortality NNT = 15 Massive Transfusion 48hr Mortality NNT = 8 Massive Transfusion 30d Mortality NNT = 7 CRASH-2 multicenter, double-blind, randomized, placebo controlled trial of ≈20k pts Primary Outcome was All-Cause 4week Mortality All-Cause Mortality NNT = 67 No Increase in VTE in Either Study
- #6 MATTERs single center retrospective observational study ≈800pts Primary Outcome: 24hr mortality, 48hr mortality and 30d mortality No difference in 24hr mortality Overall 48hr mortality NNT = 13 Overall 30d Mortality NNT = 15 Massive Transfusion 48hr Mortality NNT = 8 Massive Transfusion 30d Mortality NNT = 7 CRASH-2 multicenter, double-blind, randomized, placebo controlled trial of ≈20k pts Primary Outcome was All-Cause 4week Mortality All-Cause Mortality NNT = 67 No Increase in VTE in Either Study
- #7 Clinical Bottom Line: In trauma patients, requiring blood products (i.e. massive transfusion protocol), the use of TXA as a 1g bolus given over 10 minutes, followed by 1g over 8hrs, in ≤3 hours from time of injury, reduces all-cause mortality without an increase in thromboembolic events. This effect seems to be greatest in the subset of patients with severe shock (SBP ≤70mmHg) and when given ≤3 hours from time of injury.
- #8 Meta-Analysis 2014 2 RCTs with ≈500pts Primary Outcomes: Mortality Neuro function, hematoma expansion, adverse events No difference in In-hospital Mortality, Unfavorable functional status or ICH NO serious adverse events TICH-2 multicenter RCT of ≈2300pts Primary Outcome was 90d functional status on mRs No difference in functional status at day 90, hematoma expansion at day 2, or mortality at day 90 Some benefit in hematoma expansion at 24hrs (3.72mL vs 4.90mL), and slightly less mortality at day 7 (9% vs 11%)
- #9 Meta-Analysis 2014 2 RCTs with ≈500pts Primary Outcomes: Mortality Neuro function, hematoma expansion, adverse events No difference in In-hospital Mortality, Unfavorable functional status or ICH NO serious adverse events TICH-2 multicenter RCT of ≈2300pts Primary Outcome was 90d functional status on mRs No difference in functional status at day 90, hematoma expansion at day 2, or mortality at day 90 Some benefit in hematoma expansion at 24hrs (3.72mL vs 4.90mL), and slightly less mortality at day 7 (9% vs 11%)
- #10 Meta-Analysis 2014 2 RCTs with ≈500pts Primary Outcomes: Mortality Neuro function, hematoma expansion, adverse events No difference in In-hospital Mortality, Unfavorable functional status or ICH NO serious adverse events TICH-2 multicenter RCT of ≈2300pts Primary Outcome was 90d functional status on mRs No difference in functional status at day 90, hematoma expansion at day 2, or mortality at day 90 Some benefit in hematoma expansion at 24hrs (3.72mL vs 4.90mL), and slightly less mortality at day 7 (9% vs 11%)
- #11 Clinical Bottom Line: TXA cannot be recommended at this time in clinical practice for spontaneous ICH based on the results of these trials, however some hypothesis generating outcomes included reductions in early death by day 7 and hematoma expansion, and hopefully future research will try and answer these questions.
- #12 Results of CRASH-3 are coming Early 2020
- #13 WOMAN Trial large RCT originally planned for composite primary outcome of death from PPH and need for hysterectomy up to 42 after delivery, changed to mortality from PPH 20k pts Death due to PPH 1.5% vs 1.9%, NNT ≈250 Death due to PPH when TXA Given ≤3hrs 1.2% vs 1.7%, NNT = 200 Fragility Index = 0…one more patient without benefit would have made study not statistically significant
- #14 WOMAN Trial large RCT originally planned for composite primary outcome of death from PPH and need for hysterectomy up to 42 after delivery, changed to mortality from PPH 20k pts Death due to PPH 1.5% vs 1.9%, NNT ≈250 Death due to PPH when TXA Given ≤3hrs 1.2% vs 1.7%, NNT = 200 Fragility Index = 0…one more patient without benefit would have made study not statistically significant
- #15 WOMAN Trial large RCT originally planned for composite primary outcome of death from PPH and need for hysterectomy up to 42 after delivery, changed to mortality from PPH 20k pts Death due to PPH 1.5% vs 1.9%, NNT ≈250 Death due to PPH when TXA Given ≤3hrs 1.2% vs 1.7%, NNT = 200 Fragility Index = 0…one more patient without benefit would have made study not statistically significant
- #16 WOMAN Trial large RCT originally planned for composite primary outcome of death from PPH and need for hysterectomy up to 42 after delivery, changed to mortality from PPH 20k pts Death due to PPH 1.5% vs 1.9%, NNT ≈250 Death due to PPH when TXA Given ≤3hrs 1.2% vs 1.7%, NNT = 200 Fragility Index = 0…one more patient without benefit would have made study not statistically significant
- #17 Clinical Take Home Point: TXA may or may not be beneficial in preventing death from bleeding in patients with PPH without increasing the risk of VTE. It is difficult to draw definitive conclusions from this trial as the NNT was still large (i.e. ≈250) and the study had a fragility index of 0.
- #18 Cochran review 2014 8 RCTs with a total of 1701 participants with acute UGIB. Primary outcome: Mortality Secondary Outcome: Rebleeding Difficult to assess adverse events and transfusion requirements All-Cause Mortality ( 8 trials with 1700 pts): TXA: 42/851 (4.9%) Placebo: 71/850 (8.4%) RR 0.60 95% I 0.42 – 0.87 P = 0.007
- #19 Cochran review 2014 8 RCTs with a total of 1701 participants with acute UGIB. Primary outcome: Mortality Secondary Outcome: Rebleeding Difficult to assess adverse events and transfusion requirements All-Cause Mortality ( 8 trials with 1700 pts): TXA: 42/851 (4.9%) Placebo: 71/850 (8.4%) RR 0.60 95% I 0.42 – 0.87 P = 0.007
- #20 Cochran review 2014 8 RCTs with a total of 1701 participants with acute UGIB. Primary outcome: Mortality Secondary Outcome: Rebleeding Difficult to assess adverse events and transfusion requirements All-Cause Mortality ( 8 trials with 1700 pts): TXA: 42/851 (4.9%) Placebo: 71/850 (8.4%) RR 0.60 95% I 0.42 – 0.87 P = 0.007
- #21 Cochran review 2014 8 RCTs with a total of 1701 participants with acute UGIB. Primary outcome: Mortality Secondary Outcome: Rebleeding Difficult to assess adverse events and transfusion requirements All-Cause Mortality ( 8 trials with 1700 pts): TXA: 42/851 (4.9%) Placebo: 71/850 (8.4%) RR 0.60 95% I 0.42 – 0.87 P = 0.007
- #22 Clinical Take Home Point: Based on the best available evidence, it appears that TXA in upper GIB may benefit mortality in the sickest patients. (i.e. massive bleeding, hemodynamic compromise, patients requiring blood transfusions, etc…). Further high-quality evidence is required to confirm or refute these findings. Optimal Dosing unclear: One trial administered TXA as IV only, 3 trials administered TXA PO, and remaining trials administered TXA IV followed by PO administration. Total daily dose of TXA ranged from 4 – 8g and ranged from 2 – 7 days, which is not realistic of what happens in an acute emergency setting
- #23 Currently, the HALT-IT trial is underway with 12,000 participants 11,035 recruited 02/26/2019 TXA loading dose (1 g IV) vs placebo (sodium chloride 0.9%) given as soon as possible after randomization followed by an IV infusion of 3 g TXA or placebo (sodium chloride 0.9%) over 24 hours Done recruiting May 2019
- #24 Zahed et al 2017 124 pts on aspirin, Plavix, or both Cessation of Bleeding at 10min Anterior Pack: 29% TXA 73% NNT = 2 ED LOS decreased, patient satisfaction higher Also a 2018 Cochrane Meta-Analysis but only one trial from 1995 with topical TXA was found…other studies looked at PO & IV TXA vs placebo
- #25 Zahed et al 2017 124 pts on aspirin, Plavix, or both Cessation of Bleeding at 10min Anterior Pack: 29% TXA 73% NNT = 2 ED LOS decreased, patient satisfaction higher Also a 2018 Cochrane Meta-Analysis but only one trial from 1995 with topical TXA was found…other studies looked at PO & IV TXA vs placebo
- #26 Zahed et al 2017 124 pts on aspirin, Plavix, or both Cessation of Bleeding at 10min Anterior Pack: 29% TXA 73% NNT = 2 ED LOS decreased, patient satisfaction higher Also a 2018 Cochrane Meta-Analysis but only one trial from 1995 with topical TXA was found…other studies looked at PO & IV TXA vs placebo
- #27 Zahed et al 2017 124 pts on aspirin, Plavix, or both Cessation of Bleeding at 10min Anterior Pack: 29% TXA 73% NNT = 2 ED LOS decreased, patient satisfaction higher Also a 2018 Cochrane Meta-Analysis but only one trial from 1995 with topical TXA was found…other studies looked at PO & IV TXA vs placebo
- #29 Systematic Review and Meta-Analysis 2012 7 trials with 2,444 pts None of the studies included applied TXA in the post-operative period (All studies investigated prophylactic effects of TXA in tonsillectomy patients) 1 Case Report 2019 Pediatric patient with nebulized TXA 250mg (<25kg)…but 500mg if patient >25kg
- #30 Systematic Review and Meta-Analysis 2012 7 trials with 2,444 pts None of the studies included applied TXA in the post-operative period (All studies investigated prophylactic effects of TXA in tonsillectomy patients) 1 Case Report 2019 Pediatric patient with nebulized TXA 250mg (<25kg)…but 500mg if patient >25kg
- #31 Systematic Review and Meta-Analysis 2012 7 trials with 2,444 pts None of the studies included applied TXA in the post-operative period (All studies investigated prophylactic effects of TXA in tonsillectomy patients) 1 Case Report 2019 Pediatric patient with nebulized TXA 250mg (<25kg)…but 500mg if patient >25kg
- #33 Case Report 2018 Nebulized TXA Also reviewed 14 cases of hemoptysis 7/14 50% had resolution at <30min RCT 2018 Nebulized TXA vs Placebo 47 pts Resolution of Hemoptysis at 5 days TXA 96% Placebo 50% NNT = 2 Also a 2016 Cochrane review of 2 RCTs but evaluated PO TXA & IV TXA…neither showed reduction in bleeding
- #34 Case Report 2018 Nebulized TXA Also reviewed 14 cases of hemoptysis 7/14 50% had resolution at <30min RCT 2018 Nebulized TXA vs Placebo 47 pts Resolution of Hemoptysis at 5 days TXA 96% Placebo 50% NNT = 2 Also a 2016 Cochrane review of 2 RCTs but evaluated PO TXA & IV TXA…neither showed reduction in bleeding
- #35 Case Report 2018 Nebulized TXA Also reviewed 14 cases of hemoptysis 7/14 50% had resolution at <30min RCT 2018 Nebulized TXA vs Placebo 47 pts Resolution of Hemoptysis at 5 days TXA 96% Placebo 50% NNT = 2 Also a 2016 Cochrane review of 2 RCTs but evaluated PO TXA & IV TXA…neither showed reduction in bleeding
- #40 What’s the latest on TXA for trauma, post-partum hemorrhage (WOMAN), epistaxis, dental bleeding GI bleed, dialysis access points, ICH (TICH2) - 10 – 12min