A Clinical Trial in Higher Risk Geriatric Patients Undergoing OHSP

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cardiometabolics

Criteria

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