DDAVP vs. Exercise in Patients With Mild Hemophilia A

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.

Conditions

• Mild Haemophilia A Without Inhibitor

Interventions

DRUG

DDAVP

The participant will take either 1 or 2 nasal sprays of IN DDAVP (known as Octostim® in Canada). After receiving IN DDAVP, the participant will rest for 30 minutes.

BEHAVIORAL

Exercise

The participant will exercise on a stationary cycle-ergometer using the previously-validated, progressively-incremental Godfrey protocol. Per the Godfrey protocol, the participant starts cycling on the calibrated cycle-ergometer with an initial exercise load dependent on their height. The workload is increased every minute in standard increments also based on the participant's height. All participants will exercise until they complete 3-minutes of cycling at 85% of their maximum predicted heart rate or exhaustion (whichever is first). Upon completion of planned exercise, work load is decreased to zero watts and participants will continue cycling at this cool-down rate for an additional 3-minutes, before getting off the ergometer.

Sponsors & Collaborators

• Canadian Hemophilia Society

  collaborator OTHER

• Unity Health Toronto

  collaborator OTHER

• Nationwide Children's Hospital

  collaborator OTHER

• The Hospital for Sick Children

  lead OTHER

Principal Investigators

• Manuel Carcao · Staff Haematologist

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

13 Years

Max Age

21 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-07-04

Primary Completion

2018-08-31

Completion

2018-08-31

Countries

• Canada

Study Locations