Status:
COMPLETED
Clinical and Genomic Responses to Open Heart Surgery
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Ischemia-reperfusion (IR) Injury
Eligibility:
All Genders
1-17 years
Phase:
PHASE3
Brief Summary
This study will be the first large scale randomized study of remote ischemic preconditioning (RIPC) ever performed and will define the role of this novel therapy as a clinical tool. This study will al...
Detailed Description
Remote ischemic preconditioning (RIPC) is a powerful, innate mechanism of protection against ischemia-reperfusion (IR) injury. During the course of previous investigations, it was shown in animal mode...
Eligibility Criteria
Inclusion
- Subject age birth (\>36 weeks gestation) to 17 years.
- Underlying cardiac anatomy and planned primary repair with no anticipated residual shunting. Repair must necessitate use of cardiopulmonary bypass.
- Informed consent/assent of subject, parent(s) or legal guardian as appropriate.
Exclusion
- Current or recent ischemic insult, defined as vascular occlusion or episode of cardiorespiratory collapse requiring medical intervention occurring within 7 days of enrollment.
- Evidence in any system for organ dysfunction that requires medical intervention.
- Current treatment with systemic anticoagulation therapy or the presence of a bleeding diathesis.
- Presence of important pulmonary or airway disease requiring medical intervention.
- Current or previous (within 10 days of screening) use of systemic corticosteroids.
- Recent (within 7 days of screening) or current documented systemic infection or sepsis.
- Anticipated unavailability of an uninstrumented limb with no anatomic or physiologic abnormality precluding administration of RIPC stimulus using a standard blood pressure cuff.
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00650507
Start Date
March 1 2008
End Date
December 1 2012
Last Update
August 27 2013
Active Locations (1)
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1
Brian W. McCrindle
Toronto, Ontario, Canada