Ignite Creation Date:
2025-12-24 @ 3:18 PM
Ignite Modification Date:
2025-12-25 @ 5:05 PM
Study NCT ID:
NCT00778492
Status:
UNKNOWN
Last Update Posted:
2008-10-23
First Post:
2008-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thrombelastogram in Patients Receiving Antiplatelet Medication Undergoing Cardiac Surgery
Sponsor:
Sheba Medical Center
Organization:
Study Overview
Official Title:
Thrombelastogram and Predicting Microvascular Bleeding in Patients Receiving Antiplatelet Medication Undergoing Cardiac Surgery
Status:
UNKNOWN
Status Verified Date:
2008-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: