NCT01318707

Brief Summary

The purpose of this study is to compare the standard collection of whole blood in tiger top tubes for serum collection versus a collection method of added FVIII to whole blood samples in the hemophilia population for routine biomarker assays to ensure reliable assay results.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

December 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2010

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 18, 2011

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

July 24, 2012

Status Verified

July 1, 2012

Enrollment Period

5 months

First QC Date

December 16, 2010

Last Update Submit

July 23, 2012

Conditions

Hemophilia A

Keywords

Severe Hemophilia AHemophilia A PatientsSerum collection vs a method of added FVIII to blood samples

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Severe Hemophilia A

You may qualify if:

  • Severe Hemophilia A

You may not qualify if:

  • If they are not diagnosed with severe hemophilia A.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lombardi Cancer Center

Washington D.C., District of Columbia, 20007, United States

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 Officials

  • Craig Kessler, MD

    Georgetown University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
IRB

Study Record Dates

First Submitted

December 16, 2010

First Posted

March 18, 2011

Study Start

December 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

July 24, 2012

Record last verified: 2012-07

Locations

US(1)