NCT02225483

Brief Summary

The is study will examine whether variation in clinical bleeding frequency and severity among boys with severe Hemophilia A (Factor VIII deficiency) is associated with variations in laboratory measurements of platelet activity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2014

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 25, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2014

Completed
6 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 3, 2017

Status Verified

January 1, 2016

Enrollment Period

1.2 years

First QC Date

August 25, 2014

Last Update Submit

February 2, 2017

Conditions

Hemophilia A

Outcome Measures

Primary Outcomes (2)

  • Procoagulant platelet-derived microparticle formation

    At time of enrollment

  • Platelet aggregation

    Whole blood platelet aggregation responses

    At time of enrollment

Study Arms (1)

Hemophilia A

Boys with Factor VIII coagulant activity less than or equal to 1%.

Eligibility Criteria

Age3 Years - 20 Years
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Boys with severe Hemophilia A, Factor VIII coagulant activity less than or equal to 1%

You may qualify if:

  • documented circulating FVIII level of ≤1%
  • age 3 - 20 years
  • may be on primary or secondary prophylaxis
  • granting of informed consent

You may not qualify if:

  • measurable inhibitor level at the time of enrollment
  • ingestion of aspirin/supplement known to influence platelet function within 14 days of blood sampling, or ibuprofen within 3 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2014

First Posted

August 26, 2014

Study Start

September 1, 2014

Primary Completion

December 1, 2015

Study Completion

December 1, 2016

Last Updated

February 3, 2017

Record last verified: 2016-01

Locations

CA(2)