NCT04215588

Brief Summary

During a cardiac surgery under cardiopulmonary bypass it is essential that an appropriate level of anticoagulation is accomplished. To achieve this, the patient is administered heparin. After completion of the surgery, protamine is given to reverse the anticoagulant action of heparin. In this prospective clinical study the researchers will investigate the impact of the two different methods to calculate the required dosage of heparin and protamine; the individualized calculation computed by the Hemostasis Management System Plus (HMS Plus, Medtronic, Minneapolis, MN) device and the weight based. The investigators hypothesize that the aforementioned methods result in different dosages and will elaborate on their impact on postoperative bleeding.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Typical duration for not_applicable

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

December 20, 2019

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

December 29, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 2, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

January 3, 2023

Status Verified

December 1, 2022

Enrollment Period

2.7 years

First QC Date

December 29, 2019

Last Update Submit

December 29, 2022

Conditions

Cardiopulmonary Bypass

Keywords

anticoagulationcardiopulmonary bypass

Outcome Measures

Primary Outcomes (2)

  • Total heparin dose

    Heparin dose measured in IU

    operation duration

  • Total protamine dose

    Protamine dose measured in mg

    At the end of the cardiopulmonary bypass

Secondary Outcomes (8)

  • Red Blood Cells transfusion

    intraoperatively

  • Red Blood Cells transfusion

    24 hours after the end of the operation

  • Fibrinogen concentrate transfusion

    intraoperatively

  • Fibrinogen concentrate transfusion

    24 hours after the end of the operation

  • Prothrombin Complex Concentrate transfusion

    intraoperatively

  • +3 more secondary outcomes

Study Arms (2)

Individualized heparin and protamine titration

ACTIVE COMPARATOR

The device Hemostasis Management System Plus (Medtronic, Minneapolis, MN) will be used to determine the patients' sensitivity to heparin and its concentration in whole blood. Then, it will automatically calculate the necessary dose for anticoagulation during bypass. The protamine dose to eliminate heparin effect will be calculated from the remaining heparin concentration (0.75mg/100 International Units circulating heparin).

Device: Hemostasis Management System Plus

Activated Clotting Time guided heparin and protamine dose

ACTIVE COMPARATOR

Heparin initial dose will be determined according to the patients' weight to achieve a required Activated Clotting Time (ACT) to initiate cardiopulmonary bypass. Subsequent doses of heparin will be administered according to ACT and protamine dose will be calculated from total heparin dose (0.75mg protamine/100 International Units heparin)

Device: Activated Coagulation Timer System Plus

Interventions

Hemostasis Management System PlusDEVICE

Hemostasis Management System Plus (Medtronic, Minneapolis, MN) is a point of care device useful in the management of heparinization during bypass. It estimates the individual heparin dose response and calculates heparin concentration (IU/ml) in whole blood.

Individualized heparin and protamine titration
Activated Coagulation Timer System PlusDEVICE

The Activated Coagulation Timer System Plus device calculates the Activated Clotting Time (ACT) in seconds.

Activated Clotting Time guided heparin and protamine dose

Eligibility Criteria

Age18 Years - 79 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Informed consent
  • elective cardiac surgery under cardiopulmonary bypass

You may not qualify if:

  • known blood disorder
  • contraindication to heparin administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aristotle University of Thessaloniki

Thessaloniki, Greece

Location

Related Publications (1)

  • Gkiouliava A, Argiriadou H, Antonitsis P, Goulas A, Papapostolou E, Sarridou D, Karapanagiotidis GT, Anastasiadis K. Individualized heparin monitoring and management reduces protamine requirements in cardiac surgery on minimal invasive extracorporeal circulation; A prospective randomized study. Perfusion. 2024 Nov;39(8):1595-1604. doi: 10.1177/02676591231204284. Epub 2023 Sep 30.

    PMID: 37776194DERIVED

Study Officials

  • Eleni Argiriadou, Dr

    Associate Professor

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD candidate

Study Record Dates

First Submitted

December 29, 2019

First Posted

January 2, 2020

Study Start

December 20, 2019

Primary Completion

September 1, 2022

Study Completion

September 30, 2022

Last Updated

January 3, 2023

Record last verified: 2022-12

Locations

GR(1)