Individualizing Hemophilia Prophylaxis Using Thromboelastography
Completed · Not applicable
Conditions studied: Hemophilia A
In brief
Currently dosing for prophylaxis is not individualized, and the general approach is to use a dose of 25-40 units/kg given 3 times per week or every other day. One of the issues with weight-based dosing is the possible over-treatment. This is likely due to the fact that laboratory tests are not sensitive enough at the low levels to support decision-making. The Thromboelastograph (TEG®) and Thromboelastometry (ROTEM®) are coagulation devices, which assess the dynamics of clot formation over time and have several characteristics which suggest they may provide important information for individualized prophylaxis treatment for our patients.
Key facts
- Study ID
- NCT02582060
- Run by
- Children's Hospital Los Angeles
- People needed
- 18
- Starts
- 2014-05-20
- Expected to finish
- 2017-12-31
- Last updated by the study team
- 2019-02-18
Who can join
Age: 5 and older, up to 70. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Males, 5-70 years, inclusive
- Plasma FVIII activity <1% documented (Laboratory result or MD documentation of Severe Hemophilia A diagnosis)
- Currently prescribed prophylaxis treatment regimen infusing ≥3 times a week
- Willing to alter their prophylaxis treatment regimen per study protocol
You may not qualify if…
- Bleeding disorder(s) other than Hemophilia A
- Current inhibitor (>0.6BU)
- Thrombocytopenia (platelet count <100,000K/µL since it can alter TEG®/ROTEM® results)
- Creatinine >2x the upper limit of normal (indicating potential platelet dysfunction)
- Prothrombin time >3 seconds above the upper limit of normal (indicating potential liver dysfunction)
- Any concurrent clinically significant major disease, frequent bleeding pattern or history of non-compliance that, in the opinion of the investigator, would make the subject unsuitable for enrollment
- Participation within the past 30 days in any other clinical study involving investigational drugs
- Planned major surgery within 30 days prior to screening or during the study period
- Current use of any medication known to have effects on the coagulation system
Where it is running
- CHLA — Los Angeles, California, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.