Actively Recruiting
Global Haemostatic Methods to Measure the Treatment Effect Following Administration of Bypassing Agents to Patients With Haemophilia With Inhibitors
Led by Karolinska Institutet · Updated on 2025-09-02
20
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Global Haemostatic Methods Following Administration of Bypassing Agents to Patients With Haemophilia With Inhibitors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided informed consent
- Meets the study population description
- Male participants aged 7 years or older
You will not qualify if you...
- No informed consent
- Age younger than 7 years
- Female participants
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 2 years
Participants are followed up to observe changes in coagulation markers after administration of bypassing agents.
Trial Site Locations
Total: 1 location
1
Karolinska University Hospital
Solna, Stockholm County, Sweden, 17176
Actively Recruiting
Research Team
R
Roza Chaireti, MD, PhD
J
Jovan Antovic, MD, Assoc Prof
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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