Thrombelastogram in Patients Receiving Antiplatelet Medication Undergoing Cardiac Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by Sheba Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00778492
First received: October 22, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  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: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Thrombelastogram and Predicting Microvascular Bleeding in Patients Receiving Antiplatelet Medication Undergoing Cardiac Surgery

Resource links provided by NLM:


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 ]

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

  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.
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Sergey Preisman, MD, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00778492     History of Changes
Other Study ID Numbers: SHEBA-08-5119-SP-CTIL
Study First Received: October 22, 2008
Last Updated: October 22, 2008
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

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on August 20, 2014