Clinical Trial – DDAVP Inhalant Product and Exercise Intervention – Hemophilia

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Nationwide Children's Hospital is running a clinical trial to test drug called DDAVP inhalant product and behavior called exercise intervention to treat hemophilia. 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. The drug is DDAVP Inhalant Product and the behavior is exercise intervention.
Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Masking Description: The randomization of the participant to a study arm will be done prior to the study visit by the pharmacy at the hospital. The Investigator and study team will know the arm each participant is in before the patient's visit. This information will also be provided to the participant before the visit.
Primary Purpose: Treatment
Official Title: Exercise Versus DDAVP in Patients With Mild Hemophilia A - is One Non-inferior to the Other and do They Work Additively in Improving Hemostasis?
Actual Study Start Date : February 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019
Contacts
Contact: Riten Kumar, MD, MSc 614) 722-3564 riten.kumar@nationwidechildrens.org
Contact: Heidi Ziegler, RN 614-722-3883 heidi.ziegler@nationwidechildrens.org
NCT Number
NCT number: NCT03379974
For enrollment please visit www.clinicaltrials.gov.
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