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Completed

NCT Number: NCT02979158

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

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.

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Key information

Conditions

Cardiopulmonary Bypass Bleeding Disorder Blood Platelet Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Platelet Disorder Platelet Dysfunction Due to Drugs Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Heart Centre Umeå University Hospital

Umeå, S-901 85, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

CPB Low Dose

Procedure

Performing CPB with low dose heparin and coated equipment

CPB High Dose

Procedure

Performing CPB with high dose heparin and uncoated equipment

Primary outcomes

  1. Assessment of platelet function following cardiopulmonary bypass using platelet aggregometry

    Time frame: 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 outcomes

  1. Postoperative bleeding

    Time frame: Postoperative bleeding 24 hrs

    Blood loss 24 hrs post surgery

Sponsors and collaborators

Lead sponsor

Umeå University

Other

Collaborators

  • Medtronic

Registry information

Official study title

Influence of Cardiopulmonary Bypass on Platelet Function in Patients With Preoperative Dual Antiplatelet Therapy:

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 1, 2016
Registry last updated
Mar 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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