Clinical trial NCT02979158: Preoperative Dual Antiplatelet Therapy: Platelet Function and Influence of Cardiopulmonary Bypass
Official title: Influence of Cardiopulmonary Bypass on Platelet Function in Patients With Preoperative Dual Antiplatelet Therapy:
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiopulmonary Bypass
Platelet Disorder
Bleeding Disorder
Platelet Dysfunction Due to Drugs
Lead sponsor: Umeå University
Sponsor class: OTHER
Collaborators: name: Medtronic
First posted: 2016-12-01
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Assessment of platelet function following cardiopulmonary bypass using platelet aggregometry
timeFrame: 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
Secondary outcomes:
measure: Postoperative bleeding
timeFrame: Postoperative bleeding 24 hrs
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Heart Centre Umeå University Hospital
Study officials:
affiliation: Department of Publich Health and Clinical Medicin, Umeå University, Sweden
name: Ulf Näslund, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Centre Umeå University Hospital Sweden
name: Magnus Hedström, MD
role: STUDY_DIRECTOR
References:
citation: Olsson A, Alfredsson J, Hakansson E, Svedjeholm R, Berglund J, Berg S. Protamine reduces whole blood platelet aggregation after cardiopulmonary bypass. Scand Cardiovasc J. 2016;50(1):58-63. doi: 10.3109/14017431.2015.1099720. Epub 2015 Oct 20.
citation: Mishra PK, Thekkudan J, Sahajanandan R, Gravenor M, Lakshmanan S, Fayaz KM, Luckraz H. The role of point-of-care assessment of platelet function in predicting postoperative bleeding and transfusion requirements after coronary artery bypass grafting. Ann Card Anaesth. 2015 Jan-Mar;18(1):45-51. doi: 10.4103/0971-9784.148321.
citation: Mollnes TE, Videm V, Christiansen D, Bergseth G, Riesenfeld J, Hovig T. Platelet compatibility of an artificial surface modified with functionally active heparin. Thromb Haemost. 1999 Sep;82(3):1132-6.