A Clinical Trial in Higher Risk Geriatric Patients Undergoing OHSP
Phase 2
Completed
- Conditions
- Heart Disease
- Registration Number
- NCT00500929
- Lead Sponsor
- Cardiometabolics
- Brief Summary
To provide information on parameters needed to design a subsequent Phase III confirmatory trial and to assess the safety and efficacy of the acute use of CMI X-11S in high-risk geriatric patients undergoing open-heart surgical procedures (OHSP) requiring cardio-pulmonary bypass.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
-
Requirement for open-heart (including emergency) surgical procedures requiring cardio-pulmonary bypass:
-
Either:
- Age ≥ 70 to <80 with a Parsonnet Mortality Risk Score of ≥13 (poor risk); OR
- Age ≥ 80
-
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method ICU Time 30 to 45 days post-surgery
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of Alberta
🇨🇦Edmonton, Alberta, Canada