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

NCT02402829 | Terminated

• 1 other identifier: 14040182
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemophilia A; Factor VIII Deficiency; Hemophilia; Hemophilia B; Factor IX Deficiency

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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

Interventions

Peripheral Vein Blood draw PROCEDURE

Drawing blood through a peripheral vein in the arm.

Hemophilia Patients

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Subjects with moderate or severe Hemophilia A or B.

You may qualify if:

• 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).

You may not qualify if:

• None

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead

Study Sites (1)

Children's Mercy Hospital

Kansas City, Missouri, 64081, United States

Location

MeSH Terms

Conditions

Hemophilia A; Hemophilia B

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, X-Linked

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2015
• First Posted: March 30, 2015
• Study Start: November 1, 2014
• Primary Completion: November 28, 2018
• Study Completion: November 28, 2018
• Last Updated: January 6, 2021

Record last verified: 2021-01

Locations

US (1)