Thrombelastogram in Patients Receiving Antiplatelet Medication Undergoing Cardiac Surgery - Full Text View

Sponsored by:	Sheba Medical Center
Information provided by:	Sheba Medical Center
ClinicalTrials.gov Identifier:	NCT00778492

Purpose

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.

Condition
Bleeding

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Thrombelastogram and Predicting Microvascular Bleeding in Patients Receiving Antiplatelet Medication Undergoing Cardiac Surgery

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery Surgery

U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:

Re-sternotomy d/t Bleeding [ Time Frame: Hospitalization Period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Chest tube output during first 24 hours after the surgery [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	60
Study Start Date:	May 2008
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Groups/Cohorts
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.

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

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

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-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.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00778492

Locations

Israel
Sheba Medical Center	Recruiting
Tel Hashomer, Israel, 52621
Contact: Sergey Preisman, MD 052-6667205 sergey.preisman@sheba.health.gov.il
Principal Investigator: Sergey Preisman, MD

Sponsors and Collaborators

Sheba Medical Center

Investigators

Principal Investigator:	Sergey Preisman, MD	Sheba Medical Center
Study Director:	Alexander Kogan, MD	Sheba Medical Center

More Information

No publications provided

Responsible Party:	Sheba Medical Center ( Sergey Preisman, MD )
Study ID Numbers:	SHEBA-08-5119-SP-CTIL
Study First Received:	October 22, 2008
Last Updated:	October 22, 2008
ClinicalTrials.gov Identifier:	NCT00778492 History of Changes
Health Authority:	Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:

Thrombelastogram
Microvascular bleeding
antiplatelet medication
cardiac surgery

consumption of blood products
preoperative platelet mapping derived from modified TEG
postoperative bleeding

Study placed in the following topic categories:

Postoperative Hemorrhage
Hemorrhage

Additional relevant MeSH terms:

Pathologic Processes
Hemorrhage

ClinicalTrials.gov processed this record on September 01, 2009