Brief Title
A Study Comparing Factor Level and Inhibitor Titer Testing Results Drawn From Central Venous Lines and Venipuncture
Official Title
A Study Comparing Factor Level and Inhibitor Titer Testing Results Drawn From Central Venous Lines and Venipuncture
Brief Summary
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.
Detailed Description
Patients with hemophilia A and B sometimes require the placement of a central venous line
(CVL). A CVL is a medical device that is placed into a vein that gives easier access to a
vein either for a blood draw or to give factor replacement product.
Patients with hemophilia are usually seen by the hemophilia doctor every year at the annual
comprehensive clinic visit. As part of this visit, the doctor usually orders routine blood
tests, including the factor level and inhibitor titer.The factor level and inhibitor blood
tests are always taken through a "peripheral stick." A peripheral stick means that a small
needle is inserted into a vein in order to obtain a blood sample. The CVL is not used for
these blood draws. This is because the investigators don't know if the infusion of factor
replacement product and heparin (a blood thinning drug used to flush the line after a factor
infusion) can cause the blood sample results to be incorrect. The current practice is to take
blood through a needle stick in the vein because the investigators can be sure that the
results are accurate.
When blood draws are taken through a peripheral stick, it can cause children with hemophilia
to be very anxious because of the pain involved with a needle stick. Also, the needle stick
can sometimes cause a bleed, which may require treatment.
The purpose of this research study is to see if factor levels and inhibitor levels are
accurate when they are drawn from a CVL instead of from a peripheral stick.
Study Type
Observational
Primary Outcome
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).
Condition
Hemophilia A
Intervention
Peripheral Vein Blood draw
Study Arms / Comparison Groups
Hemophilia Patients
Description: Subjects diagnosed with moderate or severe Hemophilia A or B who use a central venous line (CVL) for regular prophylaxis factor infusions and are at the clinic for a standard of care visit. As part of the study all subjects will have blood drawn through their CVL and will also undergo a peripheral vein blood draw.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
3
Start Date
November 2014
Completion Date
November 28, 2018
Primary Completion Date
November 28, 2018
Eligibility Criteria
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
Gender
Male
Ages
1 Year - 21 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02402829
Organization ID
14040182
Responsible Party
Sponsor
Study Sponsor
Children's Mercy Hospital Kansas City
Study Sponsor
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Verification Date
January 2021