NCT06550505

Brief Summary

Evaluation and following of a protocol using viscoelastic test for the management of high risk patients in cardiac surgery

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2020

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

March 20, 2020

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

November 30, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2022

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2022

Completed
2.4 years until next milestone

First Posted

Study publicly available on registry

August 13, 2024

Completed
Last Updated

August 13, 2024

Status Verified

August 1, 2024

Enrollment Period

2 years

First QC Date

November 30, 2021

Last Update Submit

August 9, 2024

Conditions

Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

  • fresh frozen plasma transfusion

    Proportion of patients transfused with fresh frozen plasma 48 hours after the surgery.

    48 hours

Eligibility Criteria

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

Adult patients. Elective or non-elective heart surgery. High risk of bleeding.

You may qualify if:

  • Adult patients
  • Elective or non-elective high risk of bleeding heart surgery
  • Non-opposition

You may not qualify if:

  • Pregnant women
  • Age \< 18 years
  • Patients under guardianship
  • Opposition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU BREST, Hôpital de la Cavale Blanche

Brest, 29200, France

Location

Study Design

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

Study Record Dates

First Submitted

November 30, 2021

First Posted

August 13, 2024

Study Start

March 20, 2020

Primary Completion

March 20, 2022

Study Completion

March 23, 2022

Last Updated

August 13, 2024

Record last verified: 2024-08

Locations

FR(1)