NCT00500929

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2007

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 13, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

March 25, 2009

Status Verified

March 1, 2009

Enrollment Period

9 months

First QC Date

July 12, 2007

Last Update Submit

March 23, 2009

Conditions

Heart Disease

Keywords

OHSPHigh riskGeriatrics

Outcome Measures

Primary Outcomes (1)

  • ICU Time

    30 to 45 days post-surgery

Interventions

CMI X-11SDRUG

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Shaohua Wang, Dr.

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 12, 2007

First Posted

July 13, 2007

Study Start

July 1, 2007

Primary Completion

April 1, 2008

Study Completion

May 1, 2008

Last Updated

March 25, 2009

Record last verified: 2009-03

Locations

CA(1)