Status:
COMPLETED
Exercise Versus DDAVP in Patients With Mild Hemophilia A
Lead Sponsor:
Nationwide Children's Hospital
Collaborating Sponsors:
The Hospital for Sick Children
Conditions:
Hemophilia A
Eligibility:
MALE
13-21 years
Phase:
PHASE4
Brief Summary
Individuals with mild hemophilia A (MHA) bleed infrequently but can in the setting of trauma which often is when participating in sports/exercise. Although both exercise and DDAVP (desmopressin) can r...
Detailed Description
Persons with mild hemophilia A (MHA) (defined as having a FVIII level of \>5% to ≈50%) bleed infrequently but can in the setting of trauma which can often is in the context of participating in sports/...
Eligibility Criteria
Inclusion
- 1\) Patients of ≥13 years of age and ≤21 years of age with MHA (FVIII:C level of ≥6% to ≤50%).
Exclusion
- A currently circulating or a history of inhibitor (0.5 BU on two or more occasions). Inhibitor development is rare in MHA.
- History of FVIII infusion (both standard-acting and extended half-life products) or DDAVP use in preceding 1 week. Patients will be instructed to hold factor use or DDAVP for 1-week prior to participation in study, except for management of acute bleeds, in which case they will be instructed to inform the PI via telephone or e-mail.
- Patients with severe arthropathy (as determined by the principal investigator) interfering with ability to exercise. Severe arthropathy is rare in MHA.
- Patients on beta-blockers, anti-platelet agents or regular non-steroidal anti-inflammatory medications (e.g. Celebrex).
- Patients who are active smokers (cigarettes, marijuana).
- Patients with a history of a recent bleed (in preceding 2 weeks) in any location or a joint/muscle bleed in the lower limbs in the preceding 4 weeks.
- Co-existence of a congenital bleeding disorder other than MHA (e.g. VWD).
- Patients with an active infectious or inflammatory condition. This includes previously identified HIV, active hepatitis B or C as reflected in elevated AST, ALT, RNA positivity for hepatitis B or C. HIV, hepatitis B and C are very rare in the age group (13-21 years) we hope to accrue in the proposed study.
- Patients who for medical reasons should not receive DDAVP \[those with renal or CNS disease (e.g. brain tumor)\] or have previously experienced adverse events with DDAVP (e.g. hypotensive event, seizure).
Key Trial Info
Start Date :
July 31 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 5 2019
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03379974
Start Date
July 31 2018
End Date
December 5 2019
Last Update
February 25 2020
Active Locations (4)
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1
Indiana Hemophilia and Thrombosis Center
Indianapolis, Indiana, United States, 46260
2
Akron Children's Hospital
Akron, Ohio, United States, 44308
3
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
4
Dayton Children's Hospital
Dayton, Ohio, United States, 45404