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
Recruitment status was Recruiting
Sponsor:
Sheba Medical Center
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
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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 |
|---|
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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.
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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: | 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 May 21, 2013