Exercise Versus DDAVP in Patients With Mild Hemophilia A

Completed · Phase 4

Conditions studied: Hemophilia A

In brief

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 raise Factor 8/Von Willebrand Factor (FVIII/VWF levels), it is not clear whether the pathophysiological mechanism is the same. Consequently it is not known if DDAVP and exercise would have additive effects in raising FVIII:C and VWF levels or if one would one negate the effect of the other. The aim of this 2 center (Sickkids and Nationwide Children's), prospective, cross-over design study is to compare the impact of exercise vs. DDAVP on hemostasis in patients with MHA and also to investigate the impact of sequentially administering these interventions on their hemostatic indices.

Key facts

Study ID

NCT03379974

Run by

Nationwide Children's Hospital

People needed

32

Starts

2018-07-31

Expected to finish

2019-12-05

Last updated by the study team

2020-02-25

Who can join

Age: 13 and older, up to 21. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 1) Patients of ≥13 years of age and ≤21 years of age with MHA (FVIII:C level of ≥6% to ≤50%).

You may not qualify if…

• 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).

Where it is running

• Indiana Hemophilia and Thrombosis Center — Indianapolis, Indiana, United States
• Akron Children's Hospital — Akron, Ohio, United States
• Nationwide Children's Hospital — Columbus, Ohio, United States
• Dayton Children's Hospital — Dayton, Ohio, United States

Full record on ClinicalTrials.gov

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