Traumatic Brain InjuryPhase 1/2NCT03304899
Fibrinogen Concentrate in Isolated Traumatic Brain Injury
A Phase 1/2 study testing RiaSTAP Injectable Product in people with Traumatic Brain Injury and Hemorrhage, run by Leila Dehghani at 1 site in Iran.
Trial summary
Fibrinogen is a unique precursor of fibrin and cannot be compensated for by other coagulation factors. If plasma fibrinogen concentrations are insufficient, hemostatic clots cannot be formed with the appropriate firmness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Hemorrhage
- What is being tested?
- RiaSTAP Injectable Product
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIran
- Study dates
- 23 Oct 2018to 21 Jan 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with severe isolated traumatic brain injury.
Who cannot join
- Severe abdomen or extremities trauma.
- Severe bleeding from abdomen or extremities.
- Congenital coagulopathy (Hemophilia, protein S and C deficiency, Factor 5 Leiden deficiency and ...).
- Warfarin, Heparin, Enoxaparin, Dabigatran and other anticoagulation drugs consumption.
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Isfahan university of medical science.
Isfahan
Mahdi Vahidian, student, +989103374626, Mehdivahid2@yahoo.com
About this study
Official title: Early Fibrinogen Concentrate in Isolated Traumatic Brain Injury and the Effect on Post Bleeding & Complications
Fibrinogen is a unique precursor of fibrin and cannot be compensated for by other coagulation factors. If plasma fibrinogen concentrations are insufficient, hemostatic clots cannot be formed with the appropriate firmness. In severe traumatic brain injury(TBI) patients, plasma fibrinogen concentrations decrease earlier and more frequently than other coagulation factors,predicting massive bleeding and death.
The purpose of this study is to try early injection of fibrinogen concentrate in severe isolated traumatic brain injury and investigation the effect of it on post bleeding and complications.
- Conditions
- Traumatic Brain Injury, Hemorrhage
- Being tested
- RiaSTAP Injectable Product
- Medical subject headings
- Brain Injuries, Traumatic, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RiaSTAP Injectable ProductDrug
RiaSTAP, Fibrinogen Concentrate (Human) is a human blood coagulation factor indicated for the treatment of acute bleeding episodes.
Dose (mg/kg body weight) =
([Target level (mg/dL) - measured level (mg/dL)])/(1.7 (mg/dL per mg/kg body weight))
| Study group | Role | What they receive |
|---|---|---|
| Case group | Experimental | Severe isolated Traumatic Brain injury patients with serum fibrinogen level under 200 mg/dl that receive Fibrinogen concentrate after common emergency resuscitation. Instruction:
1. Airway control \& breathing.
2. Circulation (Serum therapy, Epinephrine,Packed cell, FFP and ...).
3. Fibrinogen Concentrate(IV injection): Each vial contains 1gr fibrinogen concentrate. Fibrinogen concentrate will be given until serum fibrinogen level riches to 200 mg/dl.
Dose (mg/kg body weight) = ([Target level (mg/dL) - measured level (mg/dL)])/(1.7 (mg/dL per mg/kg body weight)) Receives: Drug: RiaSTAP Injectable Product |
| Control group | Active comparator | Severe isolated Traumatic Brain injury patients with serum fibrinogen level under 200 mg/dl that receive common emergency resuscitation. Instruction:
1. Airway control \& breathing.
2. Circulation (Serum therapy, Epinephrine,Packed cell, FFP and ...). Receives: Drug: RiaSTAP Injectable Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality rate.
Mortality rate after injection of fibrinogen concentrate.
Measured: Until 90 days after admission.
Average of serum fibrinogen level.
Average of serum fibrinogen level in iTBI patient.
Measured: Immediately after admission.
The effect of early fibrinogen on post trauma bleeding (Intracranial hemorrhage).
The need to packed cell, FFP, Platelete.
Measured: 2, 6, 24, 72 hours and 30 , 90 days after admission.
Secondary outcomes (1)
The complications that related to fibrinogen concentrate.
like DVT, PTE, MI.by measurement of serum D-dimer for DVT and PTE and serum Troponin C for MI.
Measured: until 90 days after admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2017
- Study start23 Oct 2018
- Primary completion21 Dec 2019 (estimated)
- Study completion21 Jan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Leila Dehghani
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Leila Dehghani, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03304899
- Sponsor's protocol ID
- Isfahan University
- Status last verified
- Feb 2019
- First submitted
- 9 Sep 2017
- Last updated
- 27 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Fibrinogen Concentrate in Isolated Traumatic Brain Injury and the Effect on Post Bleeding & Complications
- ClinicalTrials.gov ID
- NCT03304899
- Acronym / sponsor ID
- Isfahan University
- Conditions
- Traumatic Brain Injury, Hemorrhage
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Leila DehghaniUniversity, hospital or other
- Study start
- 23 Oct 2018 (actual)
- Primary completion
- 21 Dec 2019 (estimated)
- Study completion
- 21 Jan 2020 (estimated)
- First posted
- 9 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fibrinogen is a unique precursor of fibrin and cannot be compensated for by other coagulation factors. If plasma fibrinogen concentrations are insufficient, hemostatic clots cannot be formed with the appropriate firmness. In severe traumatic brain injury(TBI) patients, plasma fibrinogen concentrations decrease earlier and more frequently than other coagulation factors,predicting massive bleeding and death.
The purpose of this study is to try early injection of fibrinogen concentrate in severe isolated traumatic brain injury and investigation the effect of it on post bleeding and complications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | Experimental | Drug: RiaSTAP Injectable ProductSevere isolated Traumatic Brain injury patients with serum fibrinogen level under 200 mg/dl that receive Fibrinogen concentrate after common emergency resuscitation. Instruction: 1. Airway control \& breathing. 2. Circulation (Serum therapy, Epinephrine,Packed cell, FFP and ...). 3. Fibrinogen Concentrate(IV injection): Each vial contains 1gr fibrinogen concentrate. Fibrinogen concentrate will be given until serum fibrinogen level riches to 200 mg/dl. Dose (mg/kg body weight) = ([Target level (mg/dL) - measured level (mg/dL)])/(1.7 (mg/dL per mg/kg body weight)) |
| Control group | Active comparator | Drug: RiaSTAP Injectable ProductSevere isolated Traumatic Brain injury patients with serum fibrinogen level under 200 mg/dl that receive common emergency resuscitation. Instruction: 1. Airway control \& breathing. 2. Circulation (Serum therapy, Epinephrine,Packed cell, FFP and ...). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with severe isolated traumatic brain injury.
Key exclusion criteria (4 listed)
- Severe abdomen or extremities trauma.
- Severe bleeding from abdomen or extremities.
- Congenital coagulopathy (Hemophilia, protein S and C deficiency, Factor 5 Leiden deficiency and ...).
- Warfarin, Heparin, Enoxaparin, Dabigatran and other anticoagulation drugs consumption.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RiaSTAP Injectable ProductRiaSTAP, Fibrinogen Concentrate (Human) is a human blood coagulation factor indicated for the treatment of acute bleeding episodes. Dose (mg/kg body weight) = ([Target level (mg/dL) - measured level (mg/dL)])/(1.7 (mg/dL per mg/kg body weight)) | Drug | Case group, Control group |
Primary outcome
Mortality rate.
Time frame: Until 90 days after admission.
Mortality rate after injection of fibrinogen concentrate.
Average of serum fibrinogen level.
Time frame: Immediately after admission.
Average of serum fibrinogen level in iTBI patient.
The effect of early fibrinogen on post trauma bleeding (Intracranial hemorrhage).
Time frame: 2, 6, 24, 72 hours and 30 , 90 days after admission.
The need to packed cell, FFP, Platelete.
1 secondary outcome
The complications that related to fibrinogen concentrate.
Time frame: until 90 days after admission.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing RiaSTAP Injectable Product in people with Traumatic Brain Injury and Hemorrhage, run by Leila Dehghani at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahdi Vahidian, Student (+989103374626, Mehdivahid2@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality rate. (time frame: Until 90 days after admission.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2019.