Autologous Fresh Whole Blood and Coagulation Following Cardiopulmonary Bypass in Infants
2 other identifiers
interventional
N/A
1 country
1
Brief 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.
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2000
CompletedFirst Posted
Study publicly available on registry
August 28, 2000
CompletedJune 24, 2005
December 1, 2003
August 25, 2000
June 23, 2005
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Undergoing non-complex open heart surgery
- Diagnosis of congenital heart disease
- No previous open heart surgery
- Weight 15 kg or less
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital
Denver, Colorado, 80218, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
Study Record Dates
First Submitted
August 25, 2000
First Posted
August 28, 2000
Last Updated
June 24, 2005
Record last verified: 2003-12