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Randomized Controlled Trial Multicenter Study
Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial.
Why is this a landmark trial?
Three reasons:
- Clinical significance of the findings: reducing maternal mortality.
- Relevance to much of world's population, in particular to low resource settings where post-partum haemorrhage (PPH) is disproportionately burdensome.
- Quality – a massive, double-blinded randomised controlled trial.
So, what did they do?
They randomised 20,060 women with PPH to receive either 1g of tranexamic acid (100mg/min slow IV) or placebo, across 21 countries and 193 hospitals. Although only 569 (2.8%) patients were from a high resource country (UK).
What did they find?
Mortality due to haemorrhage was reduced by almost 20% (RR 0.81, NNT 267) after receiving tranexamic acid (TXA), and by 30% (RR 0.69) when given within 3 hours of birth.
Hysterectomies were not reduced by TXA use. There was no increased risk of thromboembolic events.
Be smart
While on the surface this suggests we should move to routine use of TXA in managing all PPH, the risk of PPH-death in most high resource countries is relatively low. 99% of all PPH deaths are in low resource countries.
In the WOMAN trial the risk of death in the placebo group was 1.9%. In contrast the latest maternal mortality data from MBRACE-UK (2014-16) reports 0.78 haemorrhage-deaths per 100,000 maternities, which using a conservative 5% PPH incidence (depending on definition), yields a PPH-mortality risk of 0.016% – 100x less than the study population.
Thus in a high resource setting the TXA NNT to avoiding one maternal death is generously at least 20,000 PPH cases.
In high resource settings, TXA use should be considered second-line therapy in managing severe PPH when other measures are inadequate. In low resource settings where maternal PPH mortality Is high, TXA reduces maternal mortality and should be routinely used.
Context is everything.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
A comparison of albumin and saline for fluid resuscitation in the intensive care unit.
ICU resuscitation with either normal saline or 4% albumin results in similar outcomes, in the absence of traumatic brain injury.
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Randomized Controlled Trial Multicenter Study
Perioperative Bridging Anticoagulation in Patients with Atrial Fibrillation.
In patients with atrial fibrillation requiring cessation of warfarin for surgery, bridging anticoagulation does not change the incidence of thromboembolism, although does increase major bleeding.
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Reg Anesth Pain Med · Jul 2013
Multicenter Study Comparative StudyUltrasound guidance reduces the risk of local anesthetic systemic toxicity following peripheral nerve blockade.
The use of ultrasound for peripheral nerve blockade reduces the incidence of systemic local anesthetic toxicity by at least 65%, possibly 80%.
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Anesthesia and analgesia · Aug 2015
Randomized Controlled Trial Multicenter Study Comparative StudyRationale and Design of the Balanced Anesthesia Study: A Prospective Randomized Clinical Trial of Two Levels of Anesthetic Depth on Patient Outcome After Major Surgery.
An association between relatively deep anesthesia, as guided by the bispectral index (BIS), and increased postoperative mortality has been demonstrated in 6 of 8 published observational studies, but association does not necessarily mean causality. Small clinical trials of anesthetic depth have demonstrated increased delirium and postoperative cognitive dysfunction in patients who were relatively deeply anesthetized, but have been inadequately powered to study mortality. A large-scale randomized study is required to determine whether causality exists. ⋯ This randomized controlled trial should definitively answer the question of whether titrating anesthetic depth makes a difference to patient outcome in a vulnerable patient group.