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Thrombelastogram in Patients Receiving Antiplatelet Medication Undergoing Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT00778492
Recruitment Status : Unknown
Verified October 2008 by Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : October 23, 2008
Last Update Posted : October 23, 2008
Sponsor:
Information provided by:
Sheba Medical Center

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.

Condition or disease
Bleeding

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 Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Thrombelastogram and Predicting Microvascular Bleeding in Patients Receiving Antiplatelet Medication Undergoing Cardiac Surgery
Study Start Date : May 2008
Estimated Primary Completion Date : October 2008
Estimated Study Completion Date : December 2008

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Re-sternotomy d/t Bleeding [ Time Frame: Hospitalization Period ]

Secondary Outcome Measures :
  1. Chest tube output during first 24 hours after the surgery [ Time Frame: 24 hours ]


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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Sergey Preisman, MD, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00778492     History of Changes
Other Study ID Numbers: SHEBA-08-5119-SP-CTIL
First Posted: October 23, 2008    Key Record Dates
Last Update Posted: October 23, 2008
Last Verified: October 2008

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

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes