NCT03752437

Brief Summary

In this study the investigators will study two dosages of heparin before extracorporeal circulation in open chest cardiac surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2019

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

November 21, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2018

Completed
10 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
Last Updated

February 15, 2022

Status Verified

February 1, 2022

Enrollment Period

2 years

First QC Date

November 21, 2018

Last Update Submit

February 14, 2022

Conditions

Extracorporeal Circulation; Complications

Outcome Measures

Primary Outcomes (1)

  • ACT performance

    Measure of ACT to be \> 400 seconds to allow extracorporeal circulation, but also \< 700 seconds to avoid excessive bleeding.

    1 minute

Study Arms (2)

Real Weight

EXPERIMENTAL

Injection of 300 IU of heparin based on REAL weight. This injection will be controlled by an ACT (activated clotting time) one minute after the injection.

Diagnostic Test: ACT (Activated Clotting Time)Drug: Heparin

Ideal Weight

EXPERIMENTAL

Injection of 300 IU of heparin based on IDEAL weight. This injection will be controlled by an ACT (activated clotting time) one minute after the injection.

Diagnostic Test: ACT (Activated Clotting Time)Drug: Heparin

Interventions

ACT (Activated Clotting Time)DIAGNOSTIC_TEST

Measure of ACT in the two arms in order to determine if injection of heparin based on ideal weight is better or not than those one on real weight.

Ideal WeightReal Weight
HeparinDRUG

300 IU of heparin

Ideal WeightReal Weight

Eligibility Criteria

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

You may qualify if:

  • All patients admitted for cardiac open chest surgery

You may not qualify if:

  • Patient's refusal
  • Antithrombin III factor \< 75%
  • Patient under treatment by heparin IV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Saint-Luc of Bouge

Namur, 5004, Belgium

Location

MeSH Terms

Interventions

Heparin

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Eric Deflandre, MD, PhD

    Astes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
Randomisation by computer, different sheet for encoding data.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: One arm will receive 300 IU of heparin based on real weight, and the other arm will receive 300 IU of heparin based on ideal weight.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Department

Study Record Dates

First Submitted

November 21, 2018

First Posted

November 26, 2018

Study Start

October 1, 2019

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

February 15, 2022

Record last verified: 2022-02

Locations

BE(1)