Trial · NCT02203968
Fibrinogen in the Initial Resuscitation of Severe Trauma (FiiRST)
NCT02203968, Phase 1, Phase 2, Completed, Sunnybrook Health Sciences Centre
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Fibrinogen in the Initial Resuscitation of Severe Trauma (FiiRST). Trials, record NCT02203968. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02203968
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Fibrinogen in the Initial Resuscitation of Severe Trauma (FiiRST)
- NCT number
- NCT02203968
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 50 participants, actual
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Conditions
- Trauma, Injury, Bleeding, Haemorrhage, Coagulopathy
- Interventions
- Fibrinogen concentrate, Placebo Comparator
- First posted
- 2014-07-30
- Last updated
- 2016-04-14
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Feasibility | One year | 1.Feasibility endpoint: 1.1Proportion of patients receiving study intervention (Fibrinogen Concentrate \[FC\] or placebo) within first hour of hospital admission. Based on the trial's sample size of 50 patients, feasibility is defined by 85% (96% confidence interval (CI) \[72% - 98%\]) of study participants receiving the study intervention within the first hour of hospital admission |
| Secondary | Other feasibility endpoints and physiologic endpoints | one year | Other feasibility endpoints:1.2.Proportion of patients receiving study intervention prior to any blood transfusion; 1.3.Times to randomization, issue, and start of infusion; 1.4.Duration of infusion; 1.5.Wastage of study intervention; 1.6.Proportion of patients with blood tests performed for all time points; 1.7.Proportion of missed patients (eligible but not randomized); 1.8.Randomization errors. Physiologic endpoints: Plasma fibrinogen levels; Rotational Thromboelastometry/ Thromboelastography parameters (functional fibrinogen, fibtem, fibtem plus); plasmin anti-plasmin complex; tissue plasminogen activator; plasminogen activator inhibitor-1; d-dimer levels; international normalized ratio \[INR\]; partial thromboplastin time; complete blood count; endogenous thrombin potential; factor XIII; factor V; and activated protein C will be obtained on admission; and +1h, +3h, +11h, +23h \& +47h following start time of study infusion |
| Other | Clinical Parameters | one year | Rates of symptomatic thromboembolic complications in both study arms defined by the evidence of any of the following any time during hospital stay: deep venous thrombosis; myocardium infarction; cerebral vascular accident; pulmonary embolism; and arterial thrombosis Rates of asymptomatic deep venous thrombosis by leg doppler at day 7 of hospital stay Mortality by exsanguination All-cause mortality at 28 days (mainly due to exsanguination; mainly neurological/ due to traumatic brain injury/ withdrawal of care; or mainly due to multiple organ failure/sepsis) Incidence of acute lung injury/ acute respiratory distress syndrome before day 28 Multiple organ failure Total amount of crystalloids used in 24h Units of blood and blood products transfused in 24h of hospitalization |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02203968
GET https://conductscience.org/api/trials/v1/NCT02203968/registered