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Autologous Fresh Whole Blood and Coagulation Following Cardiopulmonary Bypass in Infants

NCT00006186 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL

Last updated 2005-06-24

No results posted yet for this study

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.

Conditions

  • Congenital Heart Defects

Interventions

PROCEDURE

Autologous fresh whole blood

Sponsors & Collaborators

  • National Center for Research Resources (NCRR)

    lead NIH

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00006186 on ClinicalTrials.gov