A Clinical Trial in Higher Risk Geriatric Patients Undergoing OHSP

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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CMI X-11S

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No