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Pilot Randomized Trial of Fibrinogen in Trauma Haemorrhage

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ClinicalTrials.gov Identifier: NCT02344069
Recruitment Status : Completed
First Posted : January 22, 2015
Last Update Posted : April 11, 2017
Sponsor:
Collaborator:
CSL Behring
Information provided by (Responsible Party):
Jakob Stensballe, MD, PhD, Rigshospitalet, Denmark

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

Condition or disease Intervention/treatment Phase
Trauma Haemorrhage Drug: Fibrinogen Drug: Placebo Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Immediate, Pre-emptive Fibrinogen Concentrate in Patients With Trauma Haemorrhage Needing Haemostatic Resuscitation - a Randomized, Controlled, Double-blinded Investigator-initiated Pilot Trial
Actual Study Start Date : February 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Fibrinogen

Arm Intervention/treatment
Active Comparator: Fibrinogen
Immediate intravenous administration as a single dose of fibrinogen concentrate (Riastap®, CSL Behring), when haemostatic resuscitation is deemed necessary by the clinician.
Drug: Fibrinogen
Human fibrinogen concentrate as a injection
Other Name: Riastap®, CSL Behring

Placebo Comparator: Placebo
Saline 0.9%
Drug: Placebo
Saline 0.9% as a injection
Other Name: Saline 0.9%




Primary Outcome Measures :
  1. TEG® Functional Fibrinogen maximum amplitude 15 min [ Time Frame: 15 min after intervention ]
    Thrombelastograph (TEG®) Functional Fibrinogen (FF) maximum amplitude (MA) in mm


Secondary Outcome Measures :
  1. TEG® Functional Fibrinogen maximum amplitude 2 hours [ Time Frame: 2 hours after intervention ]
    Thrombelastograph (TEG®) Functional Fibrinogen (FF) maximum amplitude (MA) in mm

  2. TEG® Functional Fibrinogen maximum amplitude 6 hours [ Time Frame: 6 hours after intervention ]
    Thrombelastograph (TEG®) Functional Fibrinogen (FF) maximum amplitude (MA) in mm

  3. TEG® Functional Fibrinogen maximum amplitude 24 hours [ Time Frame: 24 hours after intervention ]
    Thrombelastograph (TEG®) Functional Fibrinogen (FF) maximum amplitude (MA) in mm

  4. TEG® Functional Fibrinogen maximum amplitude 72 hours [ Time Frame: 72 hours after intervention ]
    Thrombelastograph (TEG®) Functional Fibrinogen (FF) maximum amplitude (MA) in mm

  5. TEG® maximum amplitude 15 min [ Time Frame: 15 min after intervention ]
    Thrombelastograph (TEG®) maximum amplitude (MA) in mm

  6. TEG® maximum amplitude 2 hours [ Time Frame: 2 hours after intervention ]
    Thrombelastograph (TEG®) maximum amplitude (MA) in mm

  7. TEG® maximum amplitude 6 hours [ Time Frame: 6 hours after intervention ]
    Thrombelastograph (TEG®) maximum amplitude (MA) in mm

  8. TEG® maximum amplitude 24 hours [ Time Frame: 24 hours after intervention ]
    Thrombelastograph (TEG®) maximum amplitude (MA) in mm

  9. TEG® maximum amplitude 72 hours [ Time Frame: 72 hours after intervention ]
    Thrombelastograph (TEG®) maximum amplitude (MA) in mm

  10. Transfusions requirements [ Time Frame: 2, 6, 24, 72 hours and in total at day 30 ]
    Transfusion requirements (Red blood cells (RBC) or fresh frozen plasma (FFP) or platelets (PLT)) at 2, 6, 24, 72 hours and in total at day 30

  11. Total use of haemostatic therapy [ Time Frame: 24 hours and 27 hours ]
    Total use of haemostatic therapy (i.e. use of coagulation factor concentrates and tranexamic acid) in the first 24 and 72 hours, omitted from this is active treatment (intervention)

  12. Time to intervention or placebo [ Time Frame: No of minutes from arrival, an expected average of 45 minutes ]
    Time from arrival to active intervention or placebo in minutes

  13. Time to FFP and PLT transfusion [ Time Frame: No of minutes from arrival, an expected average of 50 minutes ]
    Time to FFP and PLT transfusion in minutes

  14. Percentage of patients receiving intervention or placebo < 1 hour of arrival [ Time Frame: 60 min from arrival ]
    Percentage of patients receiving intervention or placebo < 1 hour of arrival

  15. Time to surgical control of bleeding [ Time Frame: No of minutes from arrival, an expected average of 120 minutes ]
    Time to surgical control of bleeding as noted by the surgeon

  16. Thromboembolism day 30 [ Time Frame: 30 days ]
    Symptomatic thromboembolism at day 30 (Severe adverse reaction)

  17. Anaphylaxis day 30 [ Time Frame: 30 days ]
    Anaphylaxis day 30 (Severe adverse reaction)

  18. 24-hour mortality [ Time Frame: 24 hours from arrival ]
    Mortality in the first 24 hours

  19. 30-day mortality [ Time Frame: 30 days from arrival ]
    Mortality in the first 30 days



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Any blood product prior to inclusion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02344069


Locations
Denmark
Rigshospitalet, Copenhagen University Hospital
Copenhagen, Denmark
Sponsors and Collaborators
Rigshospitalet, Denmark
CSL Behring
Investigators
Principal Investigator: Jakob Stensballe, MD, PhD Rigshospitalet, Denmark

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jakob Stensballe, MD, PhD, Consultant Anaesthetist, MD, PhD, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02344069     History of Changes
Other Study ID Numbers: PRooF-iTH
2014-003978-16 ( EudraCT Number )
First Posted: January 22, 2015    Key Record Dates
Last Update Posted: April 11, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jakob Stensballe, MD, PhD, Rigshospitalet, Denmark:
Fibrinogen

Additional relevant MeSH terms:
Hemorrhage
Wounds and Injuries
Pathologic Processes
Hemostatics
Coagulants