A Study Comparing Factor Level and Inhibitor Titer Testing Results Drawn From Central Venous Lines and Venipuncture (CVL#2)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02402829|
Recruitment Status : Terminated (lack of participation or interest in other sites.)
First Posted : March 30, 2015
Last Update Posted : January 6, 2021
|Condition or disease||Intervention/treatment|
|Hemophilia A Factor VIII Deficiency Hemophilia Hemophilia B Factor IX Deficiency||Procedure: Peripheral Vein Blood draw|
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|
|Actual Enrollment :||3 participants|
|Official Title:||A Study Comparing Factor Level and Inhibitor Titer Testing Results Drawn From Central Venous Lines and Venipuncture|
|Study Start Date :||November 2014|
|Actual Primary Completion Date :||November 28, 2018|
|Actual Study Completion Date :||November 28, 2018|
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.
- 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). [ Time Frame: 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). [ Time Frame: 15 minutes after the infustion of a factor replacement product ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02402829
|United States, Missouri|
|Children's Mercy Hospital|
|Kansas City, Missouri, United States, 64081|