NCT02712879

Brief Summary

Determine a bleeding threshold by measuring the blood volume in ml / kg / h collected in the drainage system to define moderate bleeding postoperative cardiac surgery and define the population.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
303

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

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 4, 2016

Completed
7 days until next milestone

Study Start

First participant enrolled

March 11, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 18, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2016

Completed
Last Updated

April 20, 2022

Status Verified

April 1, 2022

Enrollment Period

4 months

First QC Date

March 4, 2016

Last Update Submit

April 19, 2022

Conditions

Heart Surgery

Outcome Measures

Primary Outcomes (1)

  • Evolution of blood loss per hour drains

    Hourly blood loss in drains during the first twelve hours

    Hourly blood loss in drains during the first twelve hours

Eligibility Criteria

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

patients admitted to intensive care after surgery for heart surgery

You may qualify if:

  • Patients in the postoperative intensive care in cardiac surgery

You may not qualify if:

  • Patients who received a heart transplant, a heart surgery beating, cardiac support establishment of long duration, or have a disease that alters the coagulation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UHMontpellier

Montpellier, 34700, France

Location

Study Officials

  • Marine SAOUR, CCA

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 4, 2016

First Posted

March 18, 2016

Study Start

March 11, 2016

Primary Completion

June 30, 2016

Study Completion

June 30, 2016

Last Updated

April 20, 2022

Record last verified: 2022-04

Locations

FR(1)