Autologous Fresh Whole Blood and Coagulation Following Cardiopulmonary Bypass in Infants
Primary Purpose
Congenital Heart Defects
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Autologous fresh whole blood
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Heart Defects focused on measuring dilutional coagulopathy
Eligibility Criteria
Inclusion Criteria: Undergoing non-complex open heart surgery Diagnosis of congenital heart disease No previous open heart surgery Weight 15 kg or less
Sites / Locations
- Children's Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00006186
First Posted
August 25, 2000
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
1. Study Identification
Unique Protocol Identification Number
NCT00006186
Brief Title
Autologous Fresh Whole Blood and Coagulation Following Cardiopulmonary Bypass in Infants
Study Type
Interventional
2. Study Status
Record Verification Date
December 2003
Overall Recruitment Status
Completed
Study Start Date
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Primary Completion Date
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Study Completion Date
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3. Sponsor/Collaborators
Name of the Sponsor
National Center for Research Resources (NCRR)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Defects
Keywords
dilutional coagulopathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Autologous fresh whole blood
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Undergoing non-complex open heart surgery
Diagnosis of congenital heart disease
No previous open heart surgery
Weight 15 kg or less
Facility Information:
Facility Name
Children's Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
12. IPD Sharing Statement
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Autologous Fresh Whole Blood and Coagulation Following Cardiopulmonary Bypass in Infants
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