NCT00778492

Brief Summary

Study Objective is to correlate the results of preoperative platelet mapping derived from modified TEG with clinically significant postoperative bleeding and consumption of blood products.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

October 22, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 23, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

October 23, 2008

Status Verified

October 1, 2008

Enrollment Period

5 months

First QC Date

October 22, 2008

Last Update Submit

October 22, 2008

Conditions

Bleeding

Keywords

ThrombelastogramMicrovascular bleedingantiplatelet medicationcardiac surgeryconsumption of blood productspreoperative platelet mapping derived from modified TEGpostoperative bleeding

Outcome Measures

Primary Outcomes (1)

  • Re-sternotomy d/t Bleeding

    Hospitalization Period

Secondary Outcomes (1)

  • Chest tube output during first 24 hours after the surgery

    24 hours

Study Arms (1)

No Treatment

Patients with the history of ingestion of aspirin and/or ADP receptor antagonist (clopidogrel or ticlopidine) for at least 7 days prior the surgery. All patients undergoing cardiac surgery with the use of cardiopulmonary bypass on elective and urgent basis.

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with the history of ingestion of aspirin and/or ADP receptor antagonist (clopidogrel or ticlopidine) for at least 7 days prior the surgery. All patients undergoing cardiac surgery with the use of cardiopulmonary bypass on elective and urgent basis.

You may qualify if:

  • Patients undergoing cardiac surgery with the history of aspirin and/or ADP receptor antagonist for at least 7 days prior the surgery

You may not qualify if:

  • Emergent surgery
  • Heart transplant surgery
  • Implantation of ventricular assist devices
  • Enrollment into conflicting study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sheba Medical Center

Tel Litwinsky, 52621, Israel

RECRUITING

MeSH Terms

Conditions

HemorrhagePostoperative Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPostoperative Complications

Study Officials

  • Sergey Preisman, MD

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

  • Alexander Kogan, MD

    Sheba Medical Center

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

October 22, 2008

First Posted

October 23, 2008

Study Start

May 1, 2008

Primary Completion

October 1, 2008

Study Completion

December 1, 2008

Last Updated

October 23, 2008

Record last verified: 2008-10

Locations

IL(1)