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Thrombelastogram in Patients Receiving Antiplatelet Medication Undergoing Cardiac Surgery

NCT ID: NCT00778492

Last Updated: 2008-10-23

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

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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Study Design:

Prospective observational study with blinded assessment of study endpoint variables. Collection of information concerning study endpoints will be performed by the investigator blinded to the results of preoperative testing of platelet function. The information will be collected from 60 patients undergoing cardiac surgery in the Department of Cardiac Surgery of Sheba Medical Center.

Study endpoints

1. Primary endpoint- resternotomy for bleeding after the surgery.
2. Secondary endpoints- chest tube output during first 24 hours after the surgery; consumption of blood products during first 3 postoperative days.

Conditions

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Bleeding

Keywords

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Thrombelastogram Microvascular bleeding antiplatelet medication cardiac surgery consumption of blood products preoperative platelet mapping derived from modified TEG postoperative bleeding

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Emergent surgery
* Heart transplant surgery
* Implantation of ventricular assist devices
* Enrollment into conflicting study
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sheba Medical Center

Principal Investigators

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Sergey Preisman, MD

Role: PRINCIPAL_INVESTIGATOR

Sheba Medical Center

Alexander Kogan, MD

Role: STUDY_DIRECTOR

Sheba Medical Center

Locations

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Sheba Medical Center

Tel Litwinsky, , Israel

Site Status RECRUITING

Countries

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Israel

Facility Contacts

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Sergey Preisman, MD

Role: primary

Other Identifiers

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SHEBA-08-5119-SP-CTIL

Identifier Type: -

Identifier Source: org_study_id