Quantification of Thrombocytes Number and Function in Patients Undergoing Prolonged Extracorporeal Circulation

• Conditions: Coagulopathy

• Registration Number: NCT02771223
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

Prolonged extracorporeal circulation (ECC) for cardiac surgery results in coagulation abnormalities, most of which related to the direct, time dependent effect of the polymer tubing and the pump rollers on the thrombocytes. Significant evidence demonstrates the effect of the duration of cardiopulmonary bypass on thrombocytes number and function, as well as on postoperative coagulopathy

Detailed Description

Quantification of the effect of ECC duration on blood coagulation and platelet number and function

* Observational study on 20 patients undergoing prolonged ECC

* Blood sampling every 30 minutes for platelet count, platelet adhesion markers and coagulation studies

* Blood test to be performed in Rambam Blood Bank Laboratory

Study Timeline

• Study First Submitted: 2016-04-22
• Status Verified: 2016-05
• Study Start: 2016-05
• Study First Submitted QC: 2016-05-10
• Study First Posted: 2016-05-13
• Last Update Submitted: 2016-05-13
• Last Update Posted: 2016-05-17
• Primary Completion: 2017-04
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• adults over 18 yo
• scheduled for prolonged cardiac surgery requiring ECC time over 3 hours

Exclusion Criteria

• documented coagulopathy
• antiplatelet therapy other then aspirin

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Platelet function apoptosis markers	1st sample - less than 10 minutes after induction of anesthesia, 2nd sample - less than 3 minutes after termination of CPB, 3rd sample - 10 minutes after protamine administration for heparin reversal, after termination of CPB	Platelet apoptosis by annexin V (Flow cytometry)
Change in Platelet function activation markers	1st sample - less than 10 minutes after induction of anesthesia, 2nd sample - less than 3 minutes after termination of CPB, 3rd sample - 10 minutes after protamine administration for heparin reversal, after termination of CPB	Platelet activation by P-selectin (Flow cytometry)

Secondary Outcome Measures

Name	Time	Method
Change in platelet count over time	Every 30 minutes - starting less than 10 minutes after induction of anesthesia, and for 7 hours or until termination of CPB and protamine administration - whichever comes first