NCT02344069

Brief Summary

Effect of immediate, pre-emptive fibrinogen concentrate in patients with trauma haemorrhage needing haemostatic resuscitation - a randomized, controlled, double-blinded investigator-initiated pilot trial

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2015

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

January 14, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 22, 2015

Completed
10 days until next milestone

Study Start

First participant enrolled

February 1, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

April 11, 2017

Status Verified

April 1, 2017

Enrollment Period

2.1 years

First QC Date

January 14, 2015

Last Update Submit

April 10, 2017

Conditions

TraumaHaemorrhage

Keywords

Fibrinogen

Outcome Measures

Primary Outcomes (1)

  • TEG® Functional Fibrinogen maximum amplitude 15 min

    Thrombelastograph (TEG®) Functional Fibrinogen (FF) maximum amplitude (MA) in mm

    15 min after intervention

Secondary Outcomes (19)

  • TEG® Functional Fibrinogen maximum amplitude 2 hours

    2 hours after intervention

  • TEG® Functional Fibrinogen maximum amplitude 6 hours

    6 hours after intervention

  • TEG® Functional Fibrinogen maximum amplitude 24 hours

    24 hours after intervention

  • TEG® Functional Fibrinogen maximum amplitude 72 hours

    72 hours after intervention

  • TEG® maximum amplitude 15 min

    15 min after intervention

  • +14 more secondary outcomes

Study Arms (2)

Fibrinogen

ACTIVE COMPARATOR

Immediate intravenous administration as a single dose of fibrinogen concentrate (Riastap®, CSL Behring), when haemostatic resuscitation is deemed necessary by the clinician.

Drug: Fibrinogen

Placebo

PLACEBO COMPARATOR

Saline 0.9%

Drug: Placebo

Interventions

FibrinogenDRUG

Human fibrinogen concentrate as a injection

Also known as: Riastap®, CSL Behring
Fibrinogen
PlaceboDRUG

Saline 0.9% as a injection

Also known as: Saline 0.9%
Placebo

Eligibility Criteria

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

You may qualify if:

  • Trauma patient received directly from the scene of the accident AND
  • Age ≥ 18 years AND
  • Initiated order of transfusion of at least one blood component within the 1st hour of arrival AND
  • Predicted to need transfusion package therapy during the initial resuscitation (first 2 hours) AND
  • Consent obtainable from patient or scientific guardians (independent physicians and/or next of kin

You may not qualify if:

  • Duration of \> 2 hours from time of accident to arrival at trauma centre OR
  • Known anticoagulant treatment (vitamin K antagonist, dabigatran, rivaroxiban, apixaban) OR
  • Severe isolated traumatic brain injury OR
  • Moribund patient with devastating injuries and expected to die within one hour of admission OR
  • Withdrawal from active therapy OR
  • Previously, within 30 days, included in a randomized trial, if known at the time of enrolment OR
  • Known body weight \< 55 kg OR

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet, Copenhagen University Hospital

Copenhagen, Copenhagen, Denmark

Location

Related Publications (1)

  • Steinmetz J, Sorensen AM, Henriksen HH, Lange T, Larsen CF, Johansson PI, Stensballe J. Pilot Randomized trial of Fibrinogen in Trauma Haemorrhage (PRooF-iTH): study protocol for a randomized controlled trial. Trials. 2016 Jul 19;17(1):327. doi: 10.1186/s13063-016-1439-5.

    PMID: 27430210DERIVED

MeSH Terms

Conditions

Wounds and InjuriesHemorrhage

Interventions

FibrinogenSodium Chloride

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acute-Phase ProteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsBlood Coagulation FactorsProtein PrecursorsBiological FactorsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Jakob Stensballe, MD, PhD

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Anaesthetist, MD, PhD

Study Record Dates

First Submitted

January 14, 2015

First Posted

January 22, 2015

Study Start

February 1, 2015

Primary Completion

March 1, 2017

Study Completion

April 1, 2017

Last Updated

April 11, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)