Autologous Fresh Whole Blood and Coagulation Following Cardiopulmonary Bypass in Infants
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Congenital Heart Defects |
Procedure: Autologous fresh whole blood |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment |
Eligibility| Ages Eligible for Study: | 1 Month and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Undergoing non-complex open heart surgery
- Diagnosis of congenital heart disease
- No previous open heart surgery
- Weight 15 kg or less
Contacts and Locations
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00006186 History of Changes |
| Other Study ID Numbers: | NCRR-M01RR00069-0621, M01RR00069 |
| Study First Received: | August 25, 2000 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Center for Research Resources (NCRR):
|
dilutional coagulopathy |
Additional relevant MeSH terms:
|
Heart Defects, Congenital Cardiovascular Abnormalities Cardiovascular Diseases Heart Diseases Congenital Abnormalities |
ClinicalTrials.gov processed this record on June 13, 2013