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NCT01571934 · ClinicalTrials.gov registry record
Inhibitor Development in Patients With Hemophilia A Undergoing Surgery
A clinical trial, sponsored by Emory University.
- Completed
- Registry status
- 30
- Enrollment target
NCT01571934: Completed study, sponsored by Emory University.
NCT01571934 is a clinical trial that has completed, run by Emory University. The registered enrollment target is 30 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01571934 has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- 30 participants
- Enrollment target
Study Summary
Hemophilia A is a genetic deficiency of factor VIII that causes blood to clot too slowly. The disease is classified based on how much factor VIII is in the blood. People with mild or moderate hemophilia A have low, but detectable, blood levels of factor VIII and bleed with trauma or surgery. At the time of surgery, they need to receive factor VIII replacement by infusion into the vein so that blood can clot normally and abnormal bleeding can be avoided. A complication of hemophilia A is the development of an antibody that binds factor VIII and makes the factor VIII infused for treatment not work properly. This antibody is called an inhibitor. In mild and moderate hemophilia A, inhibitors are not common, but have been reported to occur after intensive factor VIII infusions, as may occur at the time of surgery. This study is designed to observe people with mild and moderate hemophilia A who are having surgery. Information on the surgery, treatments given, bleeding, and infection will be gathered. Also, blood will be drawn to determine how the immune system is reacting to the factor VIII. No specific treatments will be given as part of this study. We will use the information to determine what influences inhibitor development. A better understanding of inhibitor development will help medical providers do things to avoid inhibitor development in this population or researchers to design new treatments.
Primary Outcome
Primary Study Endpoint: Inhibitor development (inhibitor titer \> 0.4 BU/ml) by post-operative (POD) day 90. Three months or 90 days was selected as the primary end point based on data collected in the case-control study where 17/18 cases had developed their inhibitor within 12 weeks of their intensive fVIII treatment and only 1 case developed the inhibitor \>16 weeks after the intensive fVIII treatment.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-11 |
| Est. Completion | 2016-03 |
What the finished NCT01571934 record still lists
NCT01571934 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 30 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01571934 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01571934 about?
NCT01571934 is a clinical study titled "Inhibitor Development in Patients With Hemophilia A Undergoing Surgery". Hemophilia A is a genetic deficiency of factor VIII that causes blood to clot too slowly. The disease is classified based on how much factor VIII is in the blood. People with mild or moderate hemophilia A have low, but detectable, blood levels of factor VIII and bleed with trauma or surgery. At the ...
What is the current status of trial NCT01571934?
This trial is currently completed. The enrollment target is 30 participants. The study started on 2011-11. Estimated completion is 2016-03.
Who is sponsoring clinical trial NCT01571934?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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