Evaluating haemostatic methods for hemophilia patients with inhibitors
Global Haemostatic Methods to Measure the Treatment Effect Following Administration of Bypassing Agents to Patients With Haemophilia With Inhibitors
Karolinska Institutet · NCT02453542
This study is testing new bleeding management methods for people with hemophilia who have developed inhibitors to see if they work better than traditional treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 7 Years and up |
| Sex | Male |
| Sponsor | Karolinska Institutet (other) |
| Locations | 1 site (Solna, Stockholm County) |
| Trial ID | NCT02453542 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the effectiveness of global haemostatic methods in patients with hemophilia who have developed inhibitors to factor concentrates. It focuses on individuals who require bypassing agents for treatment, as traditional coagulation tests may not accurately monitor their response to therapy. The study will gather data on the utility of these methods in managing bleeding episodes in this challenging patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with hemophilia A or B who have developed inhibitors to factor concentrates.
Not a fit: Patients under the age of 7 or those unable to provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve treatment monitoring and outcomes for hemophilia patients with inhibitors.
How similar studies have performed: While the approach is novel in this specific context, similar studies have explored global haemostatic methods in other patient populations with varying degrees of success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * informed consent * meets the study population description Exclusion Criteria: * no informed consent age\<7 years
Where this trial is running
Solna, Stockholm County
- Karolinska University Hospital — Solna, Stockholm County, Sweden (RECRUITING)
Study contacts
- Principal investigator: Roza Chaireti, MD, PhD — Karolinska Institutet
- Study coordinator: Roza Chaireti, MD, PhD
- Email: roza.chaireti@ki.se
- Phone: +46 738 5170974
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hemophilia, hemophilia, inhibitors, thrombin