NCT01675817

Brief Summary

Recent work has shown that heparin rebound is common after cardiac surgery. The exact doze of protamine required to neutralize heparin at the end of CPB is unknown. Besides, the precise doze of protamine to treat heparin rebound is also unknown. It is also unknown if precise titration of protamine perioperatively in cardiac surgery can influence transfusion requirements after cardiac surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2011

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

April 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

September 25, 2019

Status Verified

September 1, 2012

Enrollment Period

1.9 years

First QC Date

August 28, 2012

Last Update Submit

September 23, 2019

Conditions

Coagulation Delay

Keywords

heparin reboundprotaminecardiopulmonary bypasscardiac surgeryanti-Xaanti-IIa

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing elective cardiac surgery

You may qualify if:

  • Age \>18 years
  • Written consent
  • Scheduled for cardiac surgery under CPB (cardiopulmonary bypass)--(elective or emergency)
  • patients undergoing cardiac surgery where CPB time is anticipated to be short (isolated primary CABG (coronary artery bypass graft);isolated mitral-valve repair or aortic-valve replacement)
  • patients undergoing cardiac surgery where CPB time is anticipated to be longer (CABG + valve surgery combined; reoperations)

You may not qualify if:

  • Known coagulopathies
  • Liver dysfunction
  • Patients receiving unfractionated or low molecular weight heparin thrombin inhibitors, warfarin, antiplatelets within the past 7 days
  • Patients expected to undergo hypothermic CPB or circulatory arrest

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dr. Ravi Taneja

London, Ontario, N6A 5A5, Canada

Location

Related Publications (1)

  • Taneja R, Berry L, Pappu U, Stitt L, Sayal P, Allen P, Hoogendoorn H, Chan A. Protamine requirements in cardiac surgery: effect of changes in the heparin reference standard. J Cardiothorac Vasc Anesth. 2014 Oct;28(5):1227-32. doi: 10.1053/j.jvca.2014.04.024.

    PMID: 25281041DERIVED

Study Officials

  • Ravi Taneja, MD, FRCPC

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2012

First Posted

August 30, 2012

Study Start

April 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

September 25, 2019

Record last verified: 2012-09

Locations

CA(1)