Recruiting

Protamine Doze

Sponsor:

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Code:

NCT03787641

Conditions

Cardiac Surgery With Cardiopulmonary Bypass

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Protamine Sulfate

Study Details

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).

Conditions

Cardiac Surgery With Cardiopulmonary Bypass

Study ID

NCT03787641

Start date

Sep 20, 2018

Status verified date

Dec, 2018

Completion date

Feb 28, 2020

Anticipated

Primary completion date

Dec 31, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Protamine doze

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 Blood samples will be withdrawn after each aliquot and quantified for anti-Xa, IIa and ACT.

Interventions

Protamine Sulfate

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.

Primary outcome measure

  • Change in heparin activity [ Time Frame: 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) [ Time Frame: Duriing surgery (at baseline, before and after protamine adminitration following cardiopulmonary bypass). ]

Central Contacts and Locations

Central contacts

Ravi Taneja, FRCPC

5196858500Ravi.Taneja@lhsc.on.ca

Locations

London Health Sciences Centre

Recruiting

London, Ontario, Canada, N6A 5A5

Contacts

Ravi Taneja, FRCPC

5196858500Ravi.Taneja@lhsc.on.ca

More Information

Sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Last update posted

Dec 31, 2018

Last verified

Dec, 2018

Keywords

  • cardiopulmonary bypass
  • heparin
  • protamine
  • anti-IIa assay
  • anti-Xa assay
  • activated clotting time

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's on 2018-12-31.