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

NCT ID: NCT02979158

Last Updated: 2018-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2018-01-24

Brief Summary

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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

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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.

Conditions

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Cardiopulmonary Bypass Platelet Disorder Bleeding Disorder Platelet Dysfunction Due to Drugs

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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CPB Low Dose

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

Group Type EXPERIMENTAL

CPB Low Dose

Intervention Type PROCEDURE

Performing CPB with low dose heparin and coated equipment

CPB High Dose

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

Group Type EXPERIMENTAL

CPB High Dose

Intervention Type PROCEDURE

Performing CPB with high dose heparin and uncoated equipment

Interventions

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CPB Low Dose

Performing CPB with low dose heparin and coated equipment

Intervention Type PROCEDURE

CPB High Dose

Performing CPB with high dose heparin and uncoated equipment

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic

INDUSTRY

Sponsor Role collaborator

Umeå University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ulf Näslund, MD PhD

Role: PRINCIPAL_INVESTIGATOR

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

Magnus Hedström, MD

Role: STUDY_DIRECTOR

Heart Centre Umeå University Hospital Sweden

Locations

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Heart Centre Umeå University Hospital

Umeå, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 26402229 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25566711 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10494777 (View on PubMed)

Other Identifiers

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DAPTUMU-123

Identifier Type: -

Identifier Source: org_study_id

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