A Study Comparing Factor Level and Inhibitor Titer Testing Results Drawn From Central Venous Lines and Venipuncture (CVL#2)

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.

Study Overview

• Status: Terminated
• Conditions: Hemophilia A; Hemophilia B; Hemophilia; Factor IX Deficiency; Factor VIII Deficiency
• Intervention / Treatment: Procedure: Peripheral Vein Blood draw

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
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Kansas City, Missouri, United States, 64081
      • Children's Mercy Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 21 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Subjects with moderate or severe Hemophilia A or B.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Hemophilia Patients; 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.	Procedure: Peripheral Vein Blood draw; Drawing blood through a peripheral vein in the arm.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Children's Mercy Hospital Kansas City

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (ACTUAL): November 28, 2018
• Study Completion (ACTUAL): November 28, 2018

Study Registration Dates

• First Submitted: January 30, 2015
• First Submitted That Met QC Criteria: March 27, 2015
• First Posted (ESTIMATE): March 30, 2015

Study Record Updates

• Last Update Posted (ACTUAL): January 6, 2021
• Last Update Submitted That Met QC Criteria: January 5, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Blood Coagulation Disorders; Hemophilia A; Hemophilia B
• Other Study ID Numbers: 14040182