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

March 26, 2018 updated by: Umeå University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Umeå, Sweden, S-901 85
        • Heart Centre Umeå University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CPB Low Dose
Conduct of cardiopulmonary bypass using a low heparin dose verified by the activated clotting time at 250 s
Procedure: CPB Low Dose
Performing CPB with low dose heparin and coated equipment
Experimental: CPB High Dose
Conduct of cardiopulmonary bypass using a high heparin dose verified by the activated clotting time at 480 s
Procedure: CPB High Dose
Performing CPB with high dose heparin and uncoated equipment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative bleeding
Time Frame: Postoperative bleeding 24 hrs
Blood loss 24 hrs post surgery
Postoperative bleeding 24 hrs

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Collaborators

Medtronic

Investigators

  • Principal Investigator: Ulf Näslund, MD PhD, Department of Publich Health and Clinical Medicin, Umeå University, Sweden
  • Study Director: Magnus Hedström, MD, Heart Centre Umeå University Hospital Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Actual)

January 24, 2018

Study Completion (Actual)

January 24, 2018

Study Registration Dates

First Submitted

November 21, 2016

First Submitted That Met QC Criteria

November 30, 2016

First Posted (Estimate)

December 1, 2016

Study Record Updates

Last Update Posted (Actual)

March 29, 2018

Last Update Submitted That Met QC Criteria

March 26, 2018

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DAPTUMU-123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Data will be shared after reviewing final results after study completion at this site and through publication in a scientific journal.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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