NCT03020849

Brief Summary

In this retrospective and prospective study, the aim is to determine a score for predicting a fibrinogen \<1.5g/L (corresponding to European threshold of Directors recommendations of fibrinogen concentrates)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,038

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

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

January 1, 2011

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 13, 2017

Completed
Last Updated

July 28, 2017

Status Verified

January 1, 2017

Enrollment Period

4.2 years

First QC Date

January 10, 2017

Last Update Submit

July 27, 2017

Conditions

Severe Trauma

Keywords

hypofibrinogenemiaprediction scoresevere trauma

Outcome Measures

Primary Outcomes (1)

  • rate of fibrinogen in blood sample at hospitalisation

    This fibrinogen rate is correlated to pre-hospital and admission clinical parameters (trauma type, physiologic status, treatments administered, biologic checkup) to predict fibrinogenemia at hospitalisation

    day 0 (at hospitalisation)

Eligibility Criteria

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

severe trauma

You may qualify if:

  • age \> 18
  • severe trauma

You may not qualify if:

  • age \<18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

HEH - Hospices Civils de Lyon

Lyon, 69003, France

Location

CHLS, Hospices Civils de Lyon

Pierre-Bénite, 69495, France

Location

MeSH Terms

Conditions

Wounds and InjuriesAfibrinogenemia

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

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

Study Record Dates

First Submitted

January 10, 2017

First Posted

January 13, 2017

Study Start

January 1, 2011

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

July 28, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)