Autologous Fresh Whole Blood and Coagulation Following Cardiopulmonary Bypass in Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Congenital Heart Defects

Keywords

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dilutional coagulopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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Autologous fresh whole blood

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

1 Month

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Locations

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Children's Hospital

Denver, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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M01RR000069

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCRR-M01RR00069-0621

Identifier Type: -

Identifier Source: org_study_id