Preoperative Dual Antiplatelet Therapy: Platelet Function and Influence of Cardiopulmonary Bypass

Not Applicable

Completed

• Conditions: Platelet Dysfunction Due to Drugs; Platelet Disorder; Cardiopulmonary Bypass; Bleeding Disorder
• Interventions: Procedure: CPB Low Dose; Procedure: CPB High Dose

• Registration Number: NCT02979158
• Lead Sponsor: Umeå University

Brief Summary

Patients admitted for coronary artery bypass surgery taking antiplatelet medicine have an increased risk for bleeding.

Present study aims to compare the platelet function in two patient groups using different types of heart-lung machine methods.

It is assumed that one of the methods is superior verified by sensitive methods of testing platelet function.

Detailed Description

Taking antiplatelet medication before cardiac surgery increases the risk for bleeding.

The surgical procedure and the use of a heart-lung machine may disturb the function of platelets, why measures to protect the existing function of platelets are of prime concern.

The present study aims to compare how two types of heart-lung machine methods influence platelet function in two groups of patients.

The platelet function will be tested before, during and after surgery by the use of two independent methods.

Study Timeline

• Status Verified: 2016-11
• Study Start: 2016-11
• Study First Submitted: 2016-11-21
• Study First Submitted QC: 2016-11-30
• Study First Posted: 2016-12-01
• Primary Completion: 2018-01-24
• Study Completion: 2018-01-24
• Last Update Submitted: 2018-03-26
• Last Update Posted: 2018-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients accepted for coronary bypass surgery with dual preoperative antiplatelet therapy suspended less than 4 days prior to surgery

Exclusion Criteria

• Abnormal coagulation verified from preoperative assessments, platelet count <100 000, Warfarin medication and renal insufficiency (GFR < 60 ml/min)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CPB Low Dose	CPB Low Dose	Conduct of cardiopulmonary bypass using a low heparin dose verified by the activated clotting time at 250 s
CPB High Dose	CPB High Dose	Conduct of cardiopulmonary bypass using a high heparin dose verified by the activated clotting time at 480 s

Primary Outcome Measures

Name	Time	Method
Assessment of platelet function following cardiopulmonary bypass using platelet aggregometry	Test of platelet function will be analysed on arrival to the operating room, post cardiopulmonary bypass and on day 1 in the intensive care unit based on the area under the curve depited from the two employed aggremometers	Included aggregometry tests: Multiplate and Rotem Platelet

Secondary Outcome Measures

Name	Time	Method
Postoperative bleeding	Postoperative bleeding 24 hrs	Blood loss 24 hrs post surgery

Trial Locations

Locations (1)

Heart Centre Umeå University Hospital; 🇸🇪 Umeå, Sweden