NCT02619539

Brief Summary

Shock-index is potentially an easy tool to estimate the risk of hypofibrinogenemia without the need to perform other potentially time consuming investigations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
280

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

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

First Submitted

Initial submission to the registry

November 30, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2017

Completed
Last Updated

March 24, 2017

Status Verified

March 1, 2017

Enrollment Period

1.2 years

First QC Date

November 30, 2015

Last Update Submit

March 22, 2017

Conditions

Trauma, Multiple

Outcome Measures

Primary Outcomes (1)

  • Proportion of subjects that have plasma fibrinogen <2.3 g.l-1 on admission among those with shock-index >1.

    On admission

Study Arms (1)

Trauma patients

All patients having / suspected to have severe trauma injuries admitted to participating centers.

Procedure: plasma fibrinogen measurement

Interventions

plasma fibrinogen measurementPROCEDURE

plasma fibrinogen measurement

Trauma patients

Eligibility Criteria

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

Patient having / suspected to have severe trauma admitted to participating centres.

You may qualify if:

  • patient having / suspected to have severe trauma transported to participating centers by cooperating Emergency Medical System organizations

You may not qualify if:

  • possible alterations of plasma fibrinogen level in the time of trauma (inflammatory disease, malignant disease, pregnancy)
  • administration of fibrinogen containing products (fresh frozen plasma, fibrinogen concentrate, cryoprecipitate) before sampling blood for fibrinogen level
  • circumstances possibly interfering with plasma fibrinogen level measurement (prior the administration of hydroxyethylstarches)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University Hospital in Plzen

Pilsen, Czechia

Location

Masaryk Hospital in Usti nad Labem

Ústí nad Labem, 40001, Czechia

Location

Related Publications (5)

  • Hagemo JS, Stanworth S, Juffermans NP, Brohi K, Cohen M, Johansson PI, Roislien J, Eken T, Naess PA, Gaarder C. Prevalence, predictors and outcome of hypofibrinogenaemia in trauma: a multicentre observational study. Crit Care. 2014 Mar 26;18(2):R52. doi: 10.1186/cc13798.

    PMID: 24666991BACKGROUND

  • Spahn DR, Bouillon B, Cerny V, Coats TJ, Duranteau J, Fernandez-Mondejar E, Filipescu D, Hunt BJ, Komadina R, Nardi G, Neugebauer E, Ozier Y, Riddez L, Schultz A, Vincent JL, Rossaint R. Management of bleeding and coagulopathy following major trauma: an updated European guideline. Crit Care. 2013 Apr 19;17(2):R76. doi: 10.1186/cc12685.

    PMID: 23601765BACKGROUND

  • Levy JH, Szlam F, Tanaka KA, Sniecienski RM. Fibrinogen and hemostasis: a primary hemostatic target for the management of acquired bleeding. Anesth Analg. 2012 Feb;114(2):261-74. doi: 10.1213/ANE.0b013e31822e1853. Epub 2011 Sep 29.

    PMID: 21965371BACKGROUND

  • Schochl H, Maegele M, Solomon C, Gorlinger K, Voelckel W. Early and individualized goal-directed therapy for trauma-induced coagulopathy. Scand J Trauma Resusc Emerg Med. 2012 Feb 24;20:15. doi: 10.1186/1757-7241-20-15.

    PMID: 22364525BACKGROUND

  • Schlimp CJ, Voelckel W, Inaba K, Maegele M, Ponschab M, Schochl H. Estimation of plasma fibrinogen levels based on hemoglobin, base excess and Injury Severity Score upon emergency room admission. Crit Care. 2013 Jul 12;17(4):R137. doi: 10.1186/cc12816.

    PMID: 23849249BACKGROUND

MeSH Terms

Conditions

Multiple Trauma

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Josef Skola, Dr.

    Masaryk Hospital Usti nad Labem

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

November 30, 2015

First Posted

December 2, 2015

Study Start

January 1, 2016

Primary Completion

February 28, 2017

Study Completion

February 28, 2017

Last Updated

March 24, 2017

Record last verified: 2017-03

Locations

CZ(2)