Delayed Rewarming for Neuroprotection in Infants Following Cardiopulmonary Bypass Surgery
Completed · Not applicable
Conditions studied: Post-Op Complication
In brief
This is an unblinded, single center, randomized study of infants with congenital heart disease undergoing cardiopulmonary bypass surgery, randomized to either the delayed rewarming intervention or to the standard of care (strict normothermia).
Key facts
- Study ID
- NCT03036072
- Run by
- Alexa Craig
- People needed
- 25
- Starts
- 2016-05-01
- Expected to finish
- 2019-05-01
- Last updated by the study team
- 2020-07-13
Who can join
Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Diagnosis of congenital heart disease requiring congenital heart surgery on bypass
- Age less than 6 months at the time of surgery
- Intra-operative hypothermia less than or equal to 35°C
You may not qualify if…
- Concern for underlying coagulation disorder such as hemophilia
- Death in the operating room
- Inability to wean of cardiopulmonary bypass at conclusion of surgery
Where it is running
- Maine Medical Center — Portland, Maine, United States
Full record on ClinicalTrials.gov
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