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

Primary Purpose

Cardiopulmonary Bypass, Platelet Disorder, Bleeding Disorder

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

CPB Low Dose

CPB High Dose

About this trial

This is an interventional treatment trial for Cardiopulmonary Bypass

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Heart Centre Umeå University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

CPB Low Dose

CPB High Dose

Arm Description

Conduct of cardiopulmonary bypass using a low heparin dose verified by the activated clotting time at 250 s

Conduct of cardiopulmonary bypass using a high heparin dose verified by the activated clotting time at 480 s

Outcomes

Primary Outcome Measures

Assessment of platelet function following cardiopulmonary bypass using platelet aggregometry

Included aggregometry tests: Multiplate and Rotem Platelet

Secondary Outcome Measures

Postoperative bleeding

Blood loss 24 hrs post surgery

Full Information

NCT ID

NCT02979158

First Posted

November 21, 2016

Last Updated

March 26, 2018

Sponsor

Umeå University

Collaborators

Medtronic

1. Study Identification

Unique Protocol Identification Number

NCT02979158

Brief Title

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

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

November 2016 (undefined)

Primary Completion Date

January 24, 2018 (Actual)

Study Completion Date

January 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Umeå University

Collaborators

Medtronic

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiopulmonary Bypass, Platelet Disorder, Bleeding Disorder, Platelet Dysfunction Due to Drugs

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CPB Low Dose

Arm Type

Experimental

Arm Description

Conduct of cardiopulmonary bypass using a low heparin dose verified by the activated clotting time at 250 s

Arm Title

CPB High Dose

Arm Type

Experimental

Arm Description

Conduct of cardiopulmonary bypass using a high heparin dose verified by the activated clotting time at 480 s

Intervention Type

Procedure

Intervention Name(s)

CPB Low Dose

Intervention Description

Performing CPB with low dose heparin and coated equipment

Intervention Type

Procedure

Intervention Name(s)

CPB High Dose

Intervention Description

Performing CPB with high dose heparin and uncoated equipment

Primary Outcome Measure Information:

Title

Assessment of platelet function following cardiopulmonary bypass using platelet aggregometry

Description

Included aggregometry tests: Multiplate and Rotem Platelet

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

Secondary Outcome Measure Information:

Title

Postoperative bleeding

Description

Blood loss 24 hrs post surgery

Time Frame

Postoperative bleeding 24 hrs

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ulf Näslund, MD PhD

Organizational Affiliation

Department of Publich Health and Clinical Medicin, Umeå University, Sweden

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Magnus Hedström, MD

Organizational Affiliation

Heart Centre Umeå University Hospital Sweden

Official's Role

Study Director

Facility Information:

Facility Name

Heart Centre Umeå University Hospital

City

Umeå

ZIP/Postal Code

S-901 85

Country

Sweden

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

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

Citations:

PubMed Identifier

26402229

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.

Results Reference

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PubMed Identifier

25566711

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.

Results Reference

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PubMed Identifier

10494777

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.

Results Reference

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

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