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

Cardiopulmonary Bypass Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02979158
• Other study ID #: DAPTUMU-123
• Status: Completed
• Phase: N/A
• First received: November 21, 2016
• Last updated: March 26, 2018
• Start date: November 2016
• Est. completion date: January 24, 2018

Study information

• Verified date: November 2016
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 24, 2018
• Est. primary completion date: January 24, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Bleeding Disorder
• Blood Coagulation Disorders
• Blood Platelet Disorders
• Cardiopulmonary Bypass
• Disease
• Hemostatic Disorders
• Platelet Disorder
• Platelet Dysfunction Due to Drugs

Intervention

Procedure:
• CPB Low Dose
Performing CPB with low dose heparin and coated equipment
• CPB High Dose
Performing CPB with high dose heparin and uncoated equipment

Locations

Country	Name	City	State
Sweden	Heart Centre Umeå University Hospital	Umeå

Sponsors (2)

Lead Sponsor	Collaborator
Umeå University	Medtronic

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

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. — View 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. — View Citation

Olsson A, Alfredsson J, Håkansson 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Postoperative bleeding	Blood loss 24 hrs post surgery	Postoperative bleeding 24 hrs