Ignite Creation Date:
2024-05-06 @ 10:52 AM
Last Modification Date:
2024-10-26 @ 12:37 PM
Study NCT ID:
NCT03379974
Status:
COMPLETED
Last Update Posted:
2020-02-25
First Post:
2017-12-05
Brief Title:
Exercise Versus DDAVP in Patients With Mild Hemophilia A
Sponsor:
Nationwide Childrens Hospital
Organization:
Nationwide Childrens Hospital
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Individuals with mild hemophilia A MHA bleed infrequently but can in the setting of trauma which often is when participating in sportsexercise Although both exercise and DDAVP desmopressin can raise Factor 8Von Willebrand Factor FVIIIVWF 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 FVIIIC and VWF levels or if one would one negate the effect of the other The aim of this 2 center Sickkids and Nationwide Childrens 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
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 sportsexercise FVIII levels temporarily rise with stress exercise and with DDAVP 1-desamino-8-Darginine vasopressin desmopressin In the case of DDAVP the Hospital for Sick Children SickKids Hemophilia Team and others have shown that FVIII and VWF levels rise by 2-4 fold with DDAVP Consequently many persons with MHA in an attempt to reduce their risk of bleeding take intranasal IN DDAVP prior to sports activitiesexercise IN DDAVP is reasonably expensive 300bottle of Octistim in Canada and 700bottle of Stimate in USA requires fluid restriction and may be associated with nausea vomiting seizures and tachyphylaxis
Recently our group completed a pilotfeasibility study to evaluate the impact of a prescribed moderate intensity aerobic exercise regimen on hemostatic indices in 30 children with hemophilia A HA or B HB all severities and documented a significant improvement in multiple coagulation parameters platelet count FVIIIC and von Willebrand factor VWF with exercise This improvement was particularly pronounced in 13 post-adolescent males with mild-moderate HA In this sub-cohort the investigators noted a mean 23 fold increase in FVIIIC immediately after exercise which remained significantly elevated at 19 fold1 hour after completion of exercise
These changes in hemostatic variables associated with aerobic exercise may be protective against bleeding and may negate the need to administer IN DDAVP immediately prior to sports participation
Although both exercise and DDAVP can raise FVIIIVWF levels it is not clear whether the pathophysiological mechanism in which they do this is the same Consequently it is not known if DDAVP and exercise would augment each others effects in raising FVIIIC and VWF levels or if one would one negate the effect of the other Herein the investigators propose a prospective interventional study of exercise vs IN DDAVP in 40-50 post adolescent 13-21 yr males with MHA to compare their impact on hemostasis and also to investigate the impact of sequentially administering these interventions on hemostatic indices
Recently our group completed a pilotfeasibility study to evaluate the impact of a prescribed moderate intensity aerobic exercise regimen on hemostatic indices in 30 children with hemophilia A HA or B HB all severities and documented a significant improvement in multiple coagulation parameters platelet count FVIIIC and von Willebrand factor VWF with exercise This improvement was particularly pronounced in 13 post-adolescent males with mild-moderate HA In this sub-cohort the investigators noted a mean 23 fold increase in FVIIIC immediately after exercise which remained significantly elevated at 19 fold1 hour after completion of exercise
These changes in hemostatic variables associated with aerobic exercise may be protective against bleeding and may negate the need to administer IN DDAVP immediately prior to sports participation
Although both exercise and DDAVP can raise FVIIIVWF levels it is not clear whether the pathophysiological mechanism in which they do this is the same Consequently it is not known if DDAVP and exercise would augment each others effects in raising FVIIIC and VWF levels or if one would one negate the effect of the other Herein the investigators propose a prospective interventional study of exercise vs IN DDAVP in 40-50 post adolescent 13-21 yr males with MHA to compare their impact on hemostasis and also to investigate the impact of sequentially administering these interventions on hemostatic indices
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None