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Hemostatic Agent

Arm A: DDAVP followed by exercise for Haemophilia A

Phase 4
Waitlist Available
Led By Manuel Carcao
Research Sponsored by The Hospital for Sick Children
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 30 min post intervention #1, 30 min post intervention#2 and 90 minute post intervention#2
Awards & highlights

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 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 Columbus, Ohio), 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.

Eligible Conditions
  • Haemophilia A

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 30 min post intervention #1, 30 min post intervention#2 and 90 minute post intervention#2
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 30 min post intervention #1, 30 min post intervention#2 and 90 minute post intervention#2 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Factor 8 level after exercise
Secondary study objectives
Associations between baseline physical activity scores and Factor 8 levels after exercise
Factor 8 level after sequential administration of exercise followed by IN DDAVP (or vice versa)

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Arm C: Exercise aloneExperimental Treatment1 Intervention
Intervention #1: Exercise Intervention #2: no further intervention (rest)
Group II: Arm A: DDAVP followed by exerciseExperimental Treatment2 Interventions
Intervention #1: DDAVP. The participant will take either 1 or 2 nasal sprays of IN DDAVP. For patients weighing \<50 kg: 150 ug (i.e. 1 spray into one nostril) and patients weighing ≥50 kg: 300 ug (i.e. 2 sprays - one into each nostril). Intervention #2: Exercise
Group III: ARM D: Exercise followed by DDAVPExperimental Treatment2 Interventions
Intervention #1: Exercise Intervention #2: DDAVP. The participant will take either 1 or 2 nasal sprays of IN DDAVP. For patients weighing \<50 kg: 150 ug (i.e. 1 spray into one nostril) and patients weighing ≥50 kg: 300 ug (i.e. 2 sprays - one into each nostril).
Group IV: Arm B: DDAVP aloneActive Control1 Intervention
Intervention #1: DDAVP. The participant will take either 1 or 2 nasal sprays of IN DDAVP. For patients weighing \<50 kg: 150 ug (i.e. 1 spray into one nostril) and patients weighing ≥50 kg: 300 ug (i.e. 2 sprays - one into each nostril). Intervention #2: no further intervention (rest)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Desmopressin
FDA approved
Exercise
2016
Completed Phase 1
~820

Find a Location

Who is running the clinical trial?

The Hospital for Sick ChildrenLead Sponsor
704 Previous Clinical Trials
6,956,847 Total Patients Enrolled
Unity Health TorontoOTHER
554 Previous Clinical Trials
454,261 Total Patients Enrolled
Nationwide Children's HospitalOTHER
347 Previous Clinical Trials
5,229,196 Total Patients Enrolled
~4 spots leftby Sep 2025
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