Key result
Idarucizumab achieved haemostasis in 15 of 17 bleeding patients and allowed 6 to undergo urgent surgery, though 50% of tested patients had prolonged coagulation times at 24 hours.
Why the study?
Does idarucizumab effectively reverse dabigatran-induced coagulopathy and improve clinical outcomes in real-world patients with bleeding or requiring urgent surgery?
Observational (n=23)
No
Does idarucizumab effectively reverse dabigatran-induced coagulopathy and improve clinical outcomes in real-world patients with bleeding or requiring urgent surgery?
In real-world practice, half of patients receiving idarucizumab for dabigatran reversal had prolonged coagulation parameters at 24 hours, particularly those with baseline renal impairment.
Idarucizumab use in bleeding or urgent procedures warrants monitoring for incomplete reversal; leaves open questions on optimal real-world protocols.
BACKGROUND: Idarucizumab is a specific antidote for the direct thrombin inhibitor oral anticoagulant dabigatran etexilate. It has been used with increasing frequency in Australia since it was granted Therapeutic Goods Administration approval in October 2016. AIMS: To assess idarucizumab usage, effect on coagulation parameters and clinical outcomes in patients who received idarucizumab in Western Sydney Local Health District (WSLHD). METHODS: A retrospective audit was conducted of all patients who received idarucizumab in WSLHD between September 2015 and December 2017. RESULTS: Of the 23 patients who received idarucizumab, 17 (74%) had bleeding, and 6 (26%) required urgent surgery/procedure. Thrombin time (TT) or activated partial thromboplastin time (APTT, when TT not available) remained prolonged at 24 h post-idarucizumab infusion in 10 of 20 (50%) patients. Renal impairment at admission was associated with prolonged TT/APTT at 24 h (P = 0.02). Of the six (26%) patients who died during hospital admission, five had raised TT/APTT at 24 h (P = 0.05). Two deaths were due to continued bleeding despite idarucizumab. Only 17% of patients received prohaemostatic treatments, and none received plasma derivatives. Despite assay availability, dabigatran drug level was only measured in eight patients. CONCLUSION: Idarucizumab helped achieve haemostasis in 15 bleeding patients and allowed 6 patients to undergo urgent surgery. Half the patients had prolonged TT/APTT at 24 h post-idarucizumab, which was more likely to occur in patients with impaired renal function.
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Brennan et al. (2018) conducted an observational in Patients on dabigatran requiring reversal for bleeding or urgent surgery (n=23). Idarucizumab was evaluated on Prolonged thrombin time (TT) or activated partial thromboplastin time (APTT) at 24 hours post-infusion. Idarucizumab achieved haemostasis in 15 of 17 bleeding patients and allowed 6 to undergo urgent surgery, though 50% of tested patients had prolonged coagulation times at 24 hours.
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