NCT03885193

Brief Summary

Activated clotting times (ACT) is employed most commonly to assess anticoagulation and ensure adequate heparin and protamine dosing during cardiopulmonary bypass (CPB). However, many studies have demonstrated a lack of correlation between plasma heparin levels and ACT during CPB. HMS Plus device estimate the free plasma heparin level from a whole-blood sample and also include the dose of protamine necessary to neutralize the circulating heparin at the end of CPB. It could predict a higher heparin dose and lower protamine dose but it's interest on postoperative bleeding and perioperative transfusion is unclear.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
188

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

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

First Submitted

Initial submission to the registry

March 18, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 21, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 14, 2019

Completed
Last Updated

March 4, 2021

Status Verified

March 1, 2021

Enrollment Period

7 months

First QC Date

March 18, 2019

Last Update Submit

March 2, 2021

Conditions

Cardiac Surgical Procedure

Keywords

anticoagulationcardiopulmonary bypassheparinprotaminepostoperatively bleeding

Outcome Measures

Primary Outcomes (1)

  • postoperative bleeding in cardiac surgery

    Compare HMS Plus and ACT Plus devices on postoperative bleeding in cardiac surgery

    First 24 hours

Study Arms (2)

HMS plus group

HMS plus device is employed to assess anticoagulation and ensure adequate heparin and protamine dosing during cardiopulmonary bypass (CPB).

ACT plus group

ACT plus device is employed to assess anticoagulation and ensure adequate heparin and protamine dosing during cardiopulmonary bypass (CPB).

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergoing elective cardiac surgery with cardiopulmonary bypass

You may qualify if:

  • Patients undergoing cardiac surgery with cardiopulmonary bypass (valve procedure, coronary artery bypass grafting (CABG), heart transplantation,..)

You may not qualify if:

  • Minors
  • Isolated aortic valve procedure unless high risk of hemorrhage (endocarditis, redo surgery)
  • Contra indication to heparin and/or protamine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nantes University Hospital

Nantes, 44093, France

Location

Study Design

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

Study Record Dates

First Submitted

March 18, 2019

First Posted

March 21, 2019

Study Start

May 1, 2019

Primary Completion

November 14, 2019

Study Completion

November 14, 2019

Last Updated

March 4, 2021

Record last verified: 2021-03

Locations

FR(1)