1. Effect of tranexamic acid by baseline risk of death in acute bleeding patients: a meta-analysis of individual patient-level data from 28 333 patients
- Author
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Francois-Xavier Ageron, Angele Gayet-Ageron, Katharine Ker, Timothy J. Coats, Haleema Shakur-Still, Ian Roberts, Aasia Kayani, Amber Geer, Bernard Ndungu, Bukola Fawole, Catherine Gilliam, Cecelia Adetayo, Collette Barrow, Danielle Beaumont, Danielle Prowse, David I'Anson, Eni Balogun, Hakim Miah, Imogen Brooks, Julio Onandia, Kiran Javaid, Laura Suncuan, Lauren Frimley, Mia Reid, Monica Arribas, Myriam Benyahia, Olujide Okunade, Phil Edwards, Rizwana Chaudhri, Sergey Kostrov, Sneha Kansagra, Tracey Pepple, Antifibrinolytics Trials Collaboration, Kayani, A., Geer, A., Ndungu, B., Fawole, B., Gilliam, C., Adetayo, C., Barrow, C., Beaumont, D., Prowse, D., I'Anson, D., Balogun, E., Miah, H., Shakur-Still, H., Roberts, I., Brooks, I., Onandia, J., Ker, K., Javaid, K., Suncuan, L., Frimley, L., Reid, M., Arribas, M., Benyahia, M., Okunade, O., Edwards, P., Chaudhri, R., Kostrov, S., Kansagra, S., and Pepple, T.
- Subjects
Adult ,Male ,Risk ,medicine.medical_specialty ,Antifibrinolytic ,medicine.drug_class ,Baseline risk ,Hemorrhage ,Antifibrinolytic Agents/therapeutic use ,03 medical and health sciences ,Young Adult ,0302 clinical medicine ,030202 anesthesiology ,Internal medicine ,medicine ,Coagulopathy ,Humans ,ddc:613 ,Randomized Controlled Trials as Topic ,ddc:618 ,business.industry ,Acute bleeding ,medicine.disease ,Postpartum haemorrhage ,Antifibrinolytic Agents ,3. Good health ,Anesthesiology and Pain Medicine ,Tranexamic Acid ,Patient level data ,Acute Disease ,Female ,Hemorrhage/drug therapy ,Tranexamic Acid/therapeutic use ,antifibrinolytics ,bleeding ,coagulopathy ,mortality ,postpartum haemorrhage ,trauma ,Meta-analysis ,business ,Tranexamic acid ,medicine.drug - Abstract
Background Early administration of the antifibrinolytic drug tranexamic acid reduces death from bleeding in trauma and postpartum haemorrhage. We examined how the effectiveness and safety of antifibrinolytic drugs varies by the baseline risk of death as a result of bleeding. Methods We performed an individual patient-level data meta-analysis of randomised trials including more than 1000 patients that assessed antifibrinolytics in acute severe bleeding. We identified trials performed between January 1, 1946 and July 5, 2018 (PROSPERO, number 42016052155). Results Two randomised trials were selected where 28 333 patients received tranexamic acid treatment within 3 h after the onset of acute bleeding. Baseline characteristics to estimate the risk of death as a result of bleeding were divided into four categories: Low (0–5%), intermediate (6–10%), high (11–20%), and very high (>20%). Most patients had a low baseline risk of death as a result of bleeding (23 008 [81%]). Deaths as a result of bleeding occurred in all baseline risk categories with 240 (1%), 202 (8%), 232 (14%), and 357 (30%) deaths in the low-, intermediate-, high-, and very high-risk categories, respectively. The effectiveness of tranexamic acid did not vary by baseline risk when given within 3 h after bleeding onset (P=0.51 for interaction term). There was no increased risk of vascular occlusive events with tranexamic acid and it did not vary by baseline risk categories (P=0.25). Conclusions Tranexamic acid appears to be safe and effective regardless of baseline risk of death. Because many deaths are in patients at low and intermediate risk, tranexamic acid use should not be restricted to the most severely injured or bleeding patients.
- Published
- 2020