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NCT00006186 Clinical Trial

Autologous Fresh Whole Blood and Coagulation Following Cardiopulmonary Bypass in Infants

Congenital Heart Defects Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00006186
Other study ID # NCRR-M01RR00069-0621
Secondary ID M01RR000069
Status Completed
Phase N/A
First received August 25, 2000
Last updated June 23, 2005

Study information
Verified date December 2003
Source National Center for Research Resources (NCRR)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

Dilution of blood caused by cardiopulmonary bypass (the heart-lung machine) during open heart surgery is associated with decreased concentrations in the blood of coagulation factors. This can be extreme in infants because of their small blood volumes and can lead to impairment of the normal blood clotting mechanism and excessive bleeding after the operation. Transfusion of fresh whole blood has been shown to be an effective treatment because fresh blood is rich in coagulation factors. However, it is difficult to obtain truly fresh blood from a blood bank. We hypothesized that fresh blood drawn from the patient and given back after cardiopulmonary bypass would improve the clotting mechanism. In our study, the infants in the treatment group have some of their own fresh blood removed after they are anesthetized for the operation and before they are placed on cardiopulmonary bypass. This blood is then given back to them after completion of cardiopulmonary bypass. Infants in the control group will not have their own blood removed but will undergo cardiopulmonary bypass. We will compare the two groups by drawing blood samples that measure coagulation tests.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 1 Month and older
Eligibility Inclusion Criteria:

- Undergoing non-complex open heart surgery

- Diagnosis of congenital heart disease

- No previous open heart surgery

- Weight 15 kg or less

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Autologous fresh whole blood

Locations
Country Name City State
United States Children's Hospital Denver Colorado

Sponsors (1)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States, 

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