Haemostasis trials

 

BART 2008

Question

Aprotinin vs TXA vs EACA

Type

·      Multi-centre, blinded RCT

Subjects

·      High risk patients undergoing cardiac surgery

Upshot (aprotinin)

·      ↓Major bleeding x0.8, but

·      ↑Mortality 1.5x

·      ↑Renal failure

·      Hence terminated early

 

CRASH-2 2010

Question

TXA in trauma

Type

·      Multi-national, double-blinded placebo-controlled RCT

Drug regimen

·      1g load, 1g infusion 8h

Upshot

·      ↓Death due to bleeding x0.85

·      ↔Blood transfusion

·      ↔Thromboembolism

 

MATTERs 2012

Question

TXA in military trauma

Type

·      Retrospective observational

Upshot

·      ↓Mortality

·      ↓Post-op coagulopathy

·      ↑Thrombotic events

Comment

·      Not a trial

 

BRIDGE 2014

Question

AF on warfarin: peri-op bridging

Type

·      Double-blinded, placebo-controlled RCT

Exclusion

·      Mechanical valve

·      PHx stroke/TIA/arterial embolism

Pre-op Mx

·      Warfarin stopped -5d

·      Dalteparin BD -3, -2, -1d

Post-op Mx

·      Dalteparin BD +12-24h if low-risk, +48-72h if high risk, until INR >2

·      Warfarin re-started +12-24h

Upshot

·      ↔Stroke/TIA/arterial embolism

·      ↔Death

·      ↑Risk major bleeding if bridged

 

ATACAS TXA 2017

Question

TXA in CAGs

Type

·      Multi-national 2x2 factorial placebo-controlled RCT

Subjects

·      High risk patients + elective CABG + not on anti-platelets

·      Load + infusion

Upshot

·      ↔Death

·      ↔Thrombotic events (AMI, stroke, PE, renal failure, bowel infarction)

·      ↓Major bleeding, tamponade, blood transfusion

·      ↑Seizures

 

ATACAS Aspirin 2017

Question

Aspirin in CAGs 1-2h pre-op

Type

·      Multi-national 2x2 factorial placebo-controlled RCT

Subjects

·      High risk patients + elective CABG + not on anti-platelets

Upshot

·      ↔Mortality

·      ↔Bleeding

·      ↔Thrombotic events

·      Hence no need to cease pre-op

 

WOMAN 2017

Question

TXA for PPH

Type

·      Multi-national, double-blinded, placebo-controlled RCT

Upshot

·      ↓Mortality due to bleeding if given within 3 hours

·      ↔Thromboembolism

 

PAUSE 2019

Question

AF on DOAC: peri-op cessation

Type

·      Prospective cohort study (RCT considered unethical)

Subjects

·      AF + DOAC + elective surgery

Exclusion

·      ↓CrCl (drug-dependent)

Pre-op Mx

·      Low risk: stop -1d

·      High risk: stop -2d

·      No bridging

Post-op Mx

·      Low risk: start +1d

·      High risk: start +2-3d with prophylactic heparin

Upshot

·      Simple stop-start is ok

·      Major bleeding 1-2%

·      Stroke 0.2-0.6%

·      PE 0.2%

 

PATCH

Question

Pre-hospital treatment of coagulopathy

Outcome

·      TBC

 

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