NCT02979158

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

December 1, 2016

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 24, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2018

Completed
Last Updated

March 29, 2018

Status Verified

November 1, 2016

Enrollment Period

1.2 years

First QC Date

November 21, 2016

Last Update Submit

March 26, 2018

Conditions

Cardiopulmonary BypassPlatelet DisorderBleeding DisorderPlatelet Dysfunction Due to Drugs

Outcome Measures

Primary Outcomes (1)

  • Assessment of platelet function following cardiopulmonary bypass using platelet aggregometry

    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 Outcomes (1)

  • Postoperative bleeding

    Postoperative bleeding 24 hrs

Study Arms (2)

CPB Low Dose

EXPERIMENTAL

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

Procedure: CPB Low Dose

CPB High Dose

EXPERIMENTAL

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

Procedure: CPB High Dose

Interventions

CPB Low DosePROCEDURE

Performing CPB with low dose heparin and coated equipment

CPB Low Dose
CPB High DosePROCEDURE

Performing CPB with high dose heparin and uncoated equipment

CPB High Dose

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients accepted for coronary bypass surgery with dual preoperative antiplatelet therapy suspended less than 4 days prior to surgery

You may not qualify if:

  • Abnormal coagulation verified from preoperative assessments, platelet count \<100 000, Warfarin medication and renal insufficiency (GFR \< 60 ml/min)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart Centre Umeå University Hospital

Umeå, S-901 85, Sweden

Location

Related Publications (3)

  • 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.

    PMID: 26402229BACKGROUND

  • 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.

    PMID: 25566711BACKGROUND

  • 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.

    PMID: 10494777BACKGROUND

MeSH Terms

Conditions

Blood Platelet DisordersHemostatic Disorders

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagic Disorders

Study Officials

  • Ulf Näslund, MD PhD

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

    PRINCIPAL INVESTIGATOR

  • Magnus Hedström, MD

    Heart Centre Umeå University Hospital Sweden

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2016

First Posted

December 1, 2016

Study Start

November 1, 2016

Primary Completion

January 24, 2018

Study Completion

January 24, 2018

Last Updated

March 29, 2018

Record last verified: 2016-11

Locations

SE(1)