21 Feb What Normalizes Bleeding Time Best After Coumadin Related Brain Bleed?
MedicalResearch.com Interview with:
Thorsten Steiner, MD, PhD
Klinikum Frankfurt Hoechst and Heidelberg University Hospital
Medical Research: What is the background for this study? What are the main findings?
Dr. Steiner: Background of the study is intracranial hemorrhage (ICH) related to vitamin-K antagonists. The mortality rate is about 60%. Main reason for the high mortality rate is hematoma expansion which occurs in about 50% during the acute phase right after the start of symptoms. We performed an investigator initiated randomized controlled trial (RCT) and found that a 4-factor prothrombin complex (PCC) is superior to fresh frozen plasma (FFP) in normalizing the international normalized ratio (INR) and prevents hematoma expansion. This let to more deaths within 48 hours in the FFP-group but had no clinical impact at 3 months – but our study was powered to detect INR normalization and not a clinical endpoint.
Medical Research: What should clinicians and patients take away from your report?
Dr. Steiner: Clinicians should consider using prothrombin complex over FFP in this indication to be applied as early as possible.
Medical Research: What recommendations do you have for future research as a result of this study?
Dr. Steiner: There will probably not be another RCT to proof that the above hemostatic and biological effect will have an impact on clinical outcome. Multimodal treatment approaches are needed to demonstrate clinical improvement in patients with intracranial hemorrhage .
Abstract presented at the 2016 International Stroke Conference
Steiner T, et al “International normalized ratio normalization in patients with Coumadin-related intracranial hemorrhages — Randomized controlled multicenter trial to compare safety and preliminary efficacy of fresh frozen plasma and prothrombin complex” ISC Meeting 2016; Abstract LB14.
Prof. Thorsten Steiner (2016). What Normalizes Bleeding Time Best After Coumadin Related Brain Bleed? MedicalResearch.com