Thrombin Generation During Cardiopulmonary Bypass With Titrated Versus Conventional Anticoagulation Management.

NCT03347201 | Completed

• 1 other identifier: 15-9761
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators will be comparing anticoagulation for Cardiopulmonary Bypass (CPB) guided by the Hemostasis Management System (HMS Plus) with the current dosing based on weight and ACT measurements. The primary objective of this study is to determine whether relative to patients with conventional management, those managed with the HMS Plus have improved thrombin generation after CPB. The secondary objective is to determine if patients in the HMS Plus group have reduced blood loss in the first 24 hours following surgery compared with patients in the conventional group.

Conditions

Cardiac Surgery

Keywords

Cardiopulmonary bypass, Heparin, Protamine

Outcome Measures

Primary Outcomes (1)

• Thrombin Generation

  The primary outcomes will be thrombin generation potential assessed via peak thrombin and endogenous thrombin potential on CAT thrombograms of plasma samples taken before, during and after cardiopulmonary bypass.

  Intra-operative

Secondary Outcomes (5)

• Rotational thromboelastometry (ROTEM)

  Intra-operative

• Activated Clotting Time (ACT)

  Intra-operative

• Platelet Function Analysis (PFA)

  Intra-operative

• Blood loss

  Intraoperative day to the 7th postoperative day inclusive

• Blood product transfusion

  Intraoperative day to the 7th postoperative day inclusive

Study Arms (2)

Intervention Group

EXPERIMENTAL

1. Initial heparin bolus before CPB to be calculated using HMS Plus. 2. Following commencement of CPB further heparin requirements will be determined using the HMS Plus. ACT's will also be checked whilst on CPB and if falls below 480 seconds, additional heparin will also be given. 3. Following cessation of CPB the dose of protamine required to reverse residual heparin will be calculated using the HMS Plus.

Device: HMS Plus

Control Group

NO INTERVENTION

Patients in the control arm will undergo routine heparin anticoagulation using a weight based initial dose of 400 units/kg, aiming for an ACT of \>480 seconds. Further heparin doses (5000 to 10000 units) will be given if the ACT falls below 480 seconds whilst on bypass. At the end of CPB heparin will be reversed with protamine using 1:1 ratio based on the initial dose of heparin given pre-bypass. HMS Plus measures will also be conducted in this group for study purposes, but the results will not be made available to the clinicians.

Interventions

HMS Plus DEVICE

Subjects randomized to the intervention group will have their dose of Heparin and Protamine calculated by the HMS Plus.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Scheduled to undergo non-emergent coronary artery bypass grafting, valve repair or replacement (with or without ascending aortic replacement) or a combination of these procedures requiring the use of CPB

You may not qualify if:

• Less than 18 years old
• Planned use of deep hypothermic circulatory arrest
• Cases where use of brief circulatory arrest anticipated
• Highly complex cases (LVAD, Heart Transplant, Complex congenital)
• Significant liver dysfunction (liver enzymes \> 2-fold higher than upper limit of normal
• Pre-existing coagulopathy (INR \>1.5, PTT \>45 seconds, fibrinogen \< 1.0g/L, platelet count \<100x109/L)
• Use of long acting oral anticoagulants
• Patients on heparin infusions pre-operatively
• Major hemoglobinopathies, thalassemia or iron storage diseases
• Previous diagnosis of HIT
• Lack of informed consent

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital, University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (1)

• Li H, Bartoszko J, Serrick C, Rao V, Karkouti K. Titrated versus conventional anticoagulation management for thrombin generation in cardiac surgery: a randomized controlled trial. Can J Anaesth. 2022 Sep;69(9):1117-1128. doi: 10.1007/s12630-022-02278-1. Epub 2022 Jul 8.

  PMID: 35799088 DERIVED

Study Officials

• Keyvan Karkouti, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Manager Anesthesia Research

Study Record Dates

• First Submitted: October 12, 2017
• First Posted: November 20, 2017
• Study Start: October 2, 2017
• Primary Completion: March 5, 2019
• Study Completion: May 28, 2019
• Last Updated: December 24, 2020

Record last verified: 2020-12

Locations

CA (1)