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OpenTrials
Completed

NCT Number: NCT00006186

Autologous Fresh Whole Blood and Coagulation Following Cardiopulmonary Bypass in Infants

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.

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Key information

Age range

1 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital

Denver, Colorado, 80218, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Autologous fresh whole blood

Procedure

Sponsors and collaborators

Lead sponsor

National Center for Research Resources (NCRR)

Nih

Registry information

Important dates

First posted
Aug 28, 2000
Registry last updated
Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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