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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02771223

Acronym

CPB-PLT-FNCT

Enrollment

Registered

2016-05-13

Start date

2016-05-31

Completion date

2017-05-31

Last updated

2016-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coagulopathy

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
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

Outcome results