Trauma patients with ongoing haemorrhage MedDRA version: 17.1 Level: LLT Classification code 10005103 Term: Bleeding System Organ Class: 100000004866 MedDRA version: 17.1 Level: LLT Classification code 10044461 Term: Trauma System Organ Class: 100000004863
Conditions
Interventions
Trade Name: Riastap
Pharmaceutical Form: Infusion
INN or Proposed INN: Human Fibrinogen coagulation factor I
CAS Number: 9001-32-5
Current Sponsor code: NA
Other descriptive name: HUMAN FIBRINOGEN
Con
Sponsors
Section for Transfusion Medicine, Capitol Region Blood Bank
Eligibility
Sex/Gender
All
Inclusion 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) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 32 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 8
Exclusion criteria
Exclusion criteria: • Duration of > 2 hours from arrival at trauma centre OR • 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 enrollment OR • Known body weight < 55 kg OR • Any blood product prior to inclusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy and safety of an immediate pre-emptive first-line treatment with fibrinogen concentrate in patients with trauma haemorrhage in need of haemostatic resuscitation.;Secondary Objective: Not applicable;Primary end point(s): • Thrombelastograph (TEG®) Functional Fibrinogen (FF) maximum amplitude (MA) in mm;Timepoint(s) of evaluation of this end point: 15 min post intervention | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • TEG® FF MA in mm at 2, 6 and 24 hours post intervention • TEG® MA in mm at 15 min, 2, 6 and 24 hours post intervention • Fibrinogen concentration (Clauss) at 15 min, 2, 6 and 24 hours post intervention • Transfusion requirements (RBC or FFP or PLT) at 6, 24 hours and total • Total use of haemostatic therapy • Time to intervention or placebo • Time to FFP and platelet transfusion • Percentage of patients receiving intervention or placebo < 1 hour of arrival • Time to anatomic haemostasis as noted by surgeon • Time to physiologic assessment of adequate resuscitation as noted by the surgeon and anaesthesiologist. Adequate resuscitation was based on qualitative improvement in blood pressure, urine output, and heart rate as well as decreased vasopressor requirements. No laboratory values or discrete measurements were required. • Time to both anatomic haemostasis and adequate resuscitation criteria were met, see two above • 24-hour and 30-day mortality • Severe adverse reactions ;Timepoint(s) of evaluation of this end point: TEG parameters at 15 min, 2, 6 and 24 hours post intervention. Transfusion requirements at 6, 24 hours and total. Mortality at 24 hours and 30 days. | — |
Countries
Denmark
Contacts
Public ContactPär I Johansson
Section for Transfusion Medicine, Capitol Region Blood Bank
Outcome results
None listed