A Study Comparing Factor Level and Inhibitor Titer Testing Results Drawn From Central Venous Lines and Venipuncture

Hemophilia A Clinical Trial

— CVL#2  

Official title:

A Study Comparing Factor Level and Inhibitor Titer Testing Results Drawn From Central Venous Lines and Venipuncture

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02402829
• Other study ID #: 14040182
• Status: Terminated
• Start date: November 2014
• Est. completion date: November 28, 2018

Study information

• Verified date: January 2021
• Source: Children's Mercy Hospital Kansas City
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Factor IX Deficiency
• Factor VIII Deficiency
• Hemophilia
• Hemophilia A
• Hemophilia B

Intervention

Procedure:
• Peripheral Vein Blood draw
Drawing blood through a peripheral vein in the arm.

Locations

Country	Name	City	State
United States	Children's Mercy Hospital	Kansas City	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Children's Mercy Hospital Kansas City

Country where clinical trial is conducted

United States, 

Outcome

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