Autologous Fresh Whole Blood and Coagulation Following Cardiopulmonary Bypass in Infants

June 23, 2005 updated by: National Center for Research Resources (NCRR)
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80218
        • Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Undergoing non-complex open heart surgery
  • Diagnosis of congenital heart disease
  • No previous open heart surgery
  • Weight 15 kg or less

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Center for Research Resources (NCRR)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

August 25, 2000

First Submitted That Met QC Criteria

August 25, 2000

First Posted (Estimate)

August 28, 2000

Study Record Updates

Last Update Posted (Estimate)

June 24, 2005

Last Update Submitted That Met QC Criteria

June 23, 2005

Last Verified

December 1, 2003

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCRR-M01RR00069-0621
  • M01RR000069 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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