NCT03787641

Brief Summary

The precise amount of protamine required to neutralize unfractionated heparin (UFH) remains unknown. This study will systematically identify the doze needed to neutralize UFH following cardiopulmonary bypass (CPB).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

May 13, 2016

Completed
2.4 years until next milestone

Study Start

First participant enrolled

September 20, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 26, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
Last Updated

December 31, 2018

Status Verified

December 1, 2018

Enrollment Period

1.3 years

First QC Date

May 13, 2016

Last Update Submit

December 27, 2018

Conditions

Cardiac Surgery With Cardiopulmonary Bypass

Keywords

cardiopulmonary bypassheparinprotamineanti-IIa assayanti-Xa assayactivated clotting time

Outcome Measures

Primary Outcomes (2)

  • Change in heparin activity

    The functional activity is ideally measured via its ability to accelerate the inhibition of activated coagulation enzymes IIa (thrombin) and Xa respectively. These tests are available commercially as ELISA kits. Briefly, an excess of coagulation factor IIa or Xa respectively is added to the sample and residual anti-IIa/Xa activity is quantified with a synthetic chromogenic substrate.

    Duriing surgery (at baseline, before and after protamine adminitration following cardiopulmonary bypass). Samples will also be quantified at Intensive Care Unit (ICU) admission and 4 hours following ICU admission.

  • Change in Activated Clotting time (ACT)

    ACT is the standard point of care test used in cardiac surgery. Blood is added to a tube containing predefined amount of coagulation accelerator (available commercially) and heparin activity is measured by prolongation or neutralization of ACT

    Duriing surgery (at baseline, before and after protamine adminitration following cardiopulmonary bypass).

Secondary Outcomes (1)

  • Rationale for choosing a certain doze of protamine

    During surgery. (Average cardiac surgery lasts for 4-6 hours)

Study Arms (1)

Protamine doze

OTHER

Protamine Sulfate will be administered through an infusion pump in aliquots at a predefined rate (25 mg/min). Blood samples will be withdrawn after each aliquot and quantified for anti-Xa, IIa and ACT.

Drug: Protamine Sulfate

Interventions

Protamine SulfateDRUG

Protamine Sulfate will be administered via an infusion pump to administer a 50 mg test doze, then 100 mg after 5 min waiting period. Following blood samples, additional alliquots of 50 mg will be measured to a maximum of 300 mg.

Protamine doze

Eligibility Criteria

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

You may qualify if:

  • Elective cardiac surgery patients \> 18 years age who can provide written consent for the study.

You may not qualify if:

  • History of any known coagulopathies, liver dysfunction, previous cardiac surgery, preoperative abnormal coagulation profiles, recent exposure to heparin (unfractionated or low molecular weight), warfarin, clopidogrel or other direct thrombin inhibitors in the preceding 7 days.
  • History of heparin resistance
  • History of adverse reactions to protamine
  • Patients identified as having heparin resistance
  • Anticipated CPB time \> 2-2.5 hrs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Centre

London, Ontario, N6A 5A5, Canada

RECRUITING

Related Publications (1)

  • Taneja R, Szoke DJ, Hynes Z, Jones PM. Minimum protamine dose required to neutralize heparin in cardiac surgery: a single-centre, prospective, observational cohort study. Can J Anaesth. 2023 Feb;70(2):219-227. doi: 10.1007/s12630-022-02364-4. Epub 2022 Dec 5.

    PMID: 36471142DERIVED

MeSH Terms

Interventions

Protamines

Intervention Hierarchy (Ancestors)

Nuclear ProteinsProteinsAmino Acids, Peptides, and ProteinsNucleoproteins

Central Study Contacts

Ravi Taneja, FRCPC

CONTACT

5196858500Ravi.Taneja@lhsc.on.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Scientist

Study Record Dates

First Submitted

May 13, 2016

First Posted

December 26, 2018

Study Start

September 20, 2018

Primary Completion

December 31, 2019

Study Completion

February 28, 2020

Last Updated

December 31, 2018

Record last verified: 2018-12

Locations

CA(1)