TraumaPhase 4NCT02864875
Early Administration of Fibrinogen in Polytraumatized Patients With Hypofibrinogenemia: a Randomized Feasibility Trial
A Phase 4 study testing Fibrinogen concentrate in people with Trauma and Bleeding Disorder, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
This is a randomized feasibility trial conducted with severe trauma patients. At admission patients presented hypofibrinogenemia, hypotension and tachycardia. The primary outcome was feasibility assessed by the proportion of patients receiving the allocated treatment up to 60 minutes after randomization. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Trauma, Bleeding Disorder, Fibrinogen; Deficiency, Acquired
- What is being tested?
- Fibrinogen concentrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- Dec 2015to Jul 2018
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 years
- Severe trauma patients (Index of Shock Severity [ISS] ≥ 15)
- Hypotension (systolic blood pressure < 90 mmHg)
- Tachycardia (heart rate > 100 bpm)
- Qualitative hypofibrinogenemia (FIBTEM A5 ≤ 9 mm)
Who cannot join
- Patient or family do not agree to sign the informed consent form
- Eligible for institutional massive transfusion protocol
- Pregnant
- Previous coagulopathy disorders
- Use of anticoagulants drugs and/or platelet anti aggregation drugs (exception for aspirin)
- Previous thromboembolic disorders or events
Show all 10Show fewer
- Cardiopulmonary arrest before hospital admission
- Patient admitted after another hospital transfer
- Time from trauma to screening above six hours
- Patients with exclusively traumatic brain injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Administration of Fibrinogen Concentrate in Polytraumatized Patients With Thromboelastometry Suggestive of Hypofibrinogenemia: a Randomized Feasibility Trial
This is a randomized feasibility trial conducted with severe trauma patients. At admission patients presented hypofibrinogenemia, hypotension and tachycardia. The primary outcome was feasibility assessed by the proportion of patients receiving the allocated treatment up to 60 minutes after randomization. The treatments regards to receive or not to receive an early replacement of fibrinogen.
Read the detailed description
This is a randomized feasibility trial conducted between December 2015 and January 2017 with severe trauma patients (Index of Shock Severity [ISS] ≥ 15) admitted to the emergency room of a large trauma center. At admission patients presented qualitative hypofibrinogenemia (FIBTEM A5 ≤ 9 mm), hypotension (systolic blood pressure <90 mmHg) and tachycardia (heart rate > 100 bpm). The primary outcome was feasibility assessed by the proportion of patients receiving the allocated treatment up to 60 minutes after randomization meaning receive replacement through fibrinogen concentrate (50mg per kg of body weight) by the intervention group and not to receive an early replacement of fibrinogen by control group.
- Conditions
- Trauma, Bleeding Disorder, Fibrinogen; Deficiency, Acquired
- Being tested
- Fibrinogen concentrate
- Keywords
- Trauma, Coagulopathy, Fibrinogen, Fibrinogen Concentrate, Thromboelastometry, Hypofibrinogenemia, Early Fibrinogen Replacement
- Medical subject headings
- Wounds and Injuries, Hemostatic Disorders, Afibrinogenemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrinogen concentrateDrug
Also called Haemocomplettan®
Receive fibrinogen concentrate 50mg/kg of body weight after randomization
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not to receive an early replacement of fibrinogen |
| Intervention | Experimental | Receive early replacement through fibrinogen concentrate (50mg per kg of body weight) Receives: Drug: Fibrinogen concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility assessed by the proportion of patients receiving the allocated treatment up to 60 minutes after randomization
The proportion of patients receiving the allocated treatment up to 60 minutes after randomization
Measured: 60 minutes
Secondary outcomes (17)
Overall blood tube drainage
Overall blood tube drainage
Measured: 48 hours
Overall blood tube drainage
Overall blood tube drainage
Measured: Up to four weeks - Through the length of hospital stay
Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate
Transfusion requirements
Measured: 48 hours
Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate
Transfusion requirements
Measured: Up to four days - Through the Length of operating room stay
Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate
Transfusion requirements
Measured: Up to four weeks - Through the Length of intensive care unit stay
Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate
Transfusion requirements
Measured: Up to four weeks - Through the Length of operating room stay
Costs of blood therapy assessed by de median value spent on each patient due to red blood cell, fresh frozen plasma, blood platelets, cryoprecipitate and fibrinogen concentrate
Costs of blood therapy
Measured: Up to four weeks - Through the Length of operating room stay
Thromboembolic events assessed by any clinical manifestation that can be related to a thromboembolic event
Thromboembolic events
Measured: First two weeks after hospital admission
Reoperate due to bleeding
Reoperate due to bleeding
Measured: Up to four weeks - Through the Length of operating room stay
Ventilator-free days
Ventilator-free days
Measured: Up to four weeks - Through the Length of operating room stay
Vasopressor-free days
Vasopressor-free days
Measured: Up to four weeks - Through the Length of operating room stay
Length of hospital stay
Length of hospital stay
Measured: Up to four weeks - Through the Length of operating room stay
Length of intensive care unit stay
Length of intensive care unit stay
Measured: Up to four weeks - Through the Length of intensive care unit stay
In-hospital Deaths
In-hospital Deaths
Measured: Up to four weeks - Through the Length of operating room stay
Sequential Organ Failure Assessment (SOFA) score on the first day after intensive care unit admission
The Sequential Organ Failure Assessment (SOFA) score is a mortality prediction score that is based on the degree of dysfunction of 6 organ systems.
The SOFA score can be used to determine the level of organ dysfunction and the mortality risk in ICU patients.
High values means worst outcomes
Measured: First day after intensive care unit admission
Sequential Organ Failure Assessment (SOFA) score on the fifth day after intensive care unit admission
The Sequential Organ Failure Assessment (SOFA) score is a mortality prediction score that is based on the degree of dysfunction of 6 organ systems.
The SOFA score can be used to determine the level of organ dysfunction and the mortality risk in ICU patients.
High values means worst outcomes
Measured: Fifth day after intensive care unit admission
Sequential Organ Failure Assessment (SOFA) score on the seventh day after intensive care unit admission
The Sequential Organ Failure Assessment (SOFA) score is a mortality prediction score that is based on the degree of dysfunction of 6 organ systems.
The SOFA score can be used to determine the level of organ dysfunction and the mortality risk in ICU patients.
High values means worst outcomes
Measured: Seventh day after intensive care unit admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2016 (estimated)
- Study startDec 2015
- Primary completionJan 2017
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucas Siqueira de Lucema, University of Sao Paulo General Hospital
- Investigators
- Lucas S Lucena, MD, Principal investigator, Hospital das Clínicas da FMUSP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02864875
- Sponsor's protocol ID
- 662.182
- Status last verified
- Jul 2018
- First submitted
- 9 Aug 2016
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lucena LS, Rodrigues RDR, Carmona MJC, Noronha FJD, Oliveira HP, Lima NM, Pinheiro RB, Silva WAD, Cavalcanti AB. Early administration of fibrinogen concentrate in patients with polytrauma with thromboelastometry suggestive of hypofibrinogenemia: A randomized feasibility trial. Clinics (Sao Paulo). 2021 Nov 8;76:e3168. doi: 10.6061/clinics/2021/e3168. eCollection 2021.
PubMed 34755760
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Administration of Fibrinogen Concentrate in Polytraumatized Patients With Thromboelastometry Suggestive of Hypofibrinogenemia: a Randomized Feasibility Trial
- ClinicalTrials.gov ID
- NCT02864875
- Acronym / sponsor ID
- 662.182
- Conditions
- Trauma, Bleeding Disorder, Fibrinogen; Deficiency, Acquired
- Keywords
- Trauma, Coagulopathy, Fibrinogen, Fibrinogen Concentrate, Thromboelastometry, Hypofibrinogenemia, Early Fibrinogen Replacement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Dec 2015 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 12 Aug 2016 (estimated)
- 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.
This is a randomized feasibility trial conducted with severe trauma patients. At admission patients presented hypofibrinogenemia, hypotension and tachycardia. The primary outcome was feasibility assessed by the proportion of patients receiving the allocated treatment up to 60 minutes after randomization. The treatments regards to receive or not to receive an early replacement of fibrinogen.
Detailed description
This is a randomized feasibility trial conducted between December 2015 and January 2017 with severe trauma patients (Index of Shock Severity [ISS] ≥ 15) admitted to the emergency room of a large trauma center. At admission patients presented qualitative hypofibrinogenemia (FIBTEM A5 ≤ 9 mm), hypotension (systolic blood pressure <90 mmHg) and tachycardia (heart rate > 100 bpm). The primary outcome was feasibility assessed by the proportion of patients receiving the allocated treatment up to 60 minutes after randomization meaning receive replacement through fibrinogen concentrate (50mg per kg of body weight) by the intervention group and not to receive an early replacement of fibrinogen by control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Not to receive an early replacement of fibrinogen |
| Intervention | Experimental | Drug: Fibrinogen concentrateReceive early replacement through fibrinogen concentrate (50mg per kg of body weight) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 80 years
- Severe trauma patients (Index of Shock Severity [ISS] ≥ 15)
- Hypotension (systolic blood pressure < 90 mmHg)
- Tachycardia (heart rate > 100 bpm)
- Qualitative hypofibrinogenemia (FIBTEM A5 ≤ 9 mm)
Key exclusion criteria (10 listed)
- Patient or family do not agree to sign the informed consent form
- Eligible for institutional massive transfusion protocol
- Pregnant
- Previous coagulopathy disorders
- Use of anticoagulants drugs and/or platelet anti aggregation drugs (exception for aspirin)
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 |
|---|---|---|
| Fibrinogen concentrateAlso: Haemocomplettan®Receive fibrinogen concentrate 50mg/kg of body weight after randomization | Drug | Intervention |
Primary outcome
Feasibility assessed by the proportion of patients receiving the allocated treatment up to 60 minutes after randomization
Time frame: 60 minutes
The proportion of patients receiving the allocated treatment up to 60 minutes after randomization
17 secondary outcomes
Overall blood tube drainage
Time frame: 48 hours
Overall blood tube drainage
Time frame: Up to four weeks - Through the length of hospital stay
Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate
Time frame: 48 hours
Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate
Time frame: Up to four days - Through the Length of operating room stay
Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate
Time frame: Up to four weeks - Through the Length of intensive care unit stay
Transfusion requirements assessed as units of red blood cell, fresh frozen plasma, blood platelets and cryoprecipitate
Time frame: Up to four weeks - Through the Length of operating room stay
Costs of blood therapy assessed by de median value spent on each patient due to red blood cell, fresh frozen plasma, blood platelets, cryoprecipitate and fibrinogen concentrate
Time frame: Up to four weeks - Through the Length of operating room stay
Thromboembolic events assessed by any clinical manifestation that can be related to a thromboembolic event
Time frame: First two weeks after hospital admission
Reoperate due to bleeding
Time frame: Up to four weeks - Through the Length of operating room stay
Ventilator-free days
Time frame: Up to four weeks - Through the Length of operating room stay
Vasopressor-free days
Time frame: Up to four weeks - Through the Length of operating room stay
Length of hospital stay
Time frame: Up to four weeks - Through the Length of operating room stay
Length of intensive care unit stay
Time frame: Up to four weeks - Through the Length of intensive care unit stay
In-hospital Deaths
Time frame: Up to four weeks - Through the Length of operating room stay
Sequential Organ Failure Assessment (SOFA) score on the first day after intensive care unit admission
Time frame: First day after intensive care unit admission
Sequential Organ Failure Assessment (SOFA) score on the fifth day after intensive care unit admission
Time frame: Fifth day after intensive care unit admission
Sequential Organ Failure Assessment (SOFA) score on the seventh day after intensive care unit admission
Time frame: Seventh day after intensive care unit admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- Derived from this study: PubMed 34755760Lucena LS, Rodrigues RDR, Carmona MJC, Noronha FJD, Oliveira HP, Lima NM, Pinheiro RB, Silva WAD, Cavalcanti AB. Early administration of fibrinogen concentrate in patients with polytrauma with thromboelastometry suggestive of hypofibrinogenemia: A randomized feasibility trial. Clinics (Sao Paulo). 2021 Nov 8;76:e3168. doi: 10.6061/clinics/2021/e3168. eCollection 2021.
- Individual participant dataSharing planned: No
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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.
Lucas S Lucena, MD principal investigator
Hospital das Clínicas da FMUSP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fibrinogen concentrate in people with Trauma and Bleeding Disorder, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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 5 inclusion and 10 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: finished, as of the sponsor's last update on 1 Aug 2018. 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 Brazil. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility assessed by the proportion of patients receiving the allocated treatment up to 60 minutes after randomization (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02864875, which also lists 1 linked publication.
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 1 Aug 2018.