Thrombelastogram in Patients Receiving Antiplatelet Medication Undergoing Cardiac Surgery

Bleeding Clinical Trial

Official title:

Thrombelastogram and Predicting Microvascular Bleeding in Patients Receiving Antiplatelet Medication Undergoing Cardiac Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00778492
• Other study ID #: SHEBA-08-5119-SP-CTIL
• Status: Recruiting
• Phase: N/A
• First received: October 22, 2008
• Last updated: October 22, 2008
• Start date: May 2008
• Est. completion date: December 2008

Study information

• Verified date: October 2008
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bleeding
• Hemorrhage

Locations

Country	Name	City	State
Israel	Sheba Medical Center	Tel Hashomer

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Re-sternotomy d/t Bleeding		Hospitalization Period	Yes
Secondary	Chest tube output during first 24 hours after the surgery		24 hours	No