Measuring Treatment Effects of Bypassing Agents in Male Patients Aged 7 and Older with Hemophilia and Inhibitors Using Global Blood Clotting Tests

What this Trial Is About

This research aims to improve treatment monitoring for patients with haemophilia A and B who develop inhibitors to coagulation factors, as well as patients with acquired haemophilia with similar inhibitor issues. The study focuses on evaluating global haemostatic methods to better assess treatment effects, aiming to enhance patient safety and treatment effectiveness. The study is observational and conducted by Karolinska Institutet with patients followed over two years. The study involves collecting blood samples at baseline and before and after administration of bypassing agents used to treat bleeding symptoms or as prophylaxis. Treatments are determined by the patients physicians and include bypassing agents such as factor eight inhibitor bypassing agent FEIBA or recombinant activated factor VII rFVIIa. The study evaluates coagulation markers using methods like thrombin generation Calibrated Automated Thrombogram and overall haemostatic potential. Participants will have blood samples taken at specific time points during the two-year follow-up to measure changes in coagulation markers in relation to clinical symptoms and inhibitor levels. The research team will analyze these markers alongside patients clinical outcomes to assess treatment effects. This monitoring aims to provide more accurate information about treatment safety and effectiveness in patients with haemophilia and inhibitors.

Global Haemostatic Methods Following Administration of Bypassing Agents to Patients With Haemophilia With Inhibitors