Hemophilia A Clinical Trial
— CVL#2Official title:
A Study Comparing Factor Level and Inhibitor Titer Testing Results Drawn From Central Venous Lines and Venipuncture
NCT number | NCT02402829 |
Other study ID # | 14040182 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | November 2014 |
Est. completion date | November 28, 2018 |
Verified date | January 2021 |
Source | Children's Mercy Hospital Kansas City |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of this research study is to see if factor levels and inhibitor levels in Hemophilia A and B subjects are accurate when they are drawn from a central venous line (CVL) instead of from a peripheral stick.
Status | Terminated |
Enrollment | 3 |
Est. completion date | November 28, 2018 |
Est. primary completion date | November 28, 2018 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 1 Year to 21 Years |
Eligibility | Inclusion Criteria: - Children and adults with hemophilia A or B, ages 1-21 who have CVLs for factor infusion and who are prescribed factor prophylaxis for treatment of their bleeding disorder will be included. - Subjects will be recruited from active patients at federally funded hemophilia treatment centers (HTCs). Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
United States | Children's Mercy Hospital | Kansas City | Missouri |
Lead Sponsor | Collaborator |
---|---|
Children's Mercy Hospital Kansas City |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluate the equivalence between coagulation labs drawn from central venous line to those drawn peripherally. Primary measurements will be done on factor levels resulted as percent of normal, and inhibitor titers resulted in Bethesda Units (BU). | within 15 minutes pre-infusion of a factor replacement product | ||
Primary | Evaluate the equivalence between coagulation labs drawn from central venous line to those drawn peripherally. Primary measurements will be done on factor levels resulted as percent of normal, and inhibitor titers resulted in Bethesda Units (BU). | 15 minutes after the infustion of a factor replacement product |
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