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Clinical Trials/NCT00778492
NCT00778492
Unknown
Not Applicable

Thrombelastogram and Predicting Microvascular Bleeding in Patients Receiving Antiplatelet Medication Undergoing Cardiac Surgery

Sheba Medical Center1 site in 1 country60 target enrollmentStarted: May 2008Last updated:
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ConditionsBleeding

Overview

Phase
Not Applicable
Enrollment
60
Locations
1
Primary Endpoint
Re-sternotomy d/t Bleeding
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Detailed Description

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Re-sternotomy d/t Bleeding

Time Frame: Hospitalization Period

Secondary Outcomes

  • Chest tube output during first 24 hours after the surgery(24 hours)

Investigators

Sponsor Class
Other Gov

Study Sites (1)

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