PolytraumaPhase 1/2PRETICNCT03780894
Transfusion of Red Blood Cells, Tranexamic Acid and Fibrinogen Concentrate for Severe Trauma Hemorrhage at Pre-hospital Phase of Care.
A Phase 1/2 study testing Fibrinogen Concentrate (Human) 1 MG [RiaSTAP], Red blood cells concentrate and Tranexamic Acid in people with Polytrauma and Traumatic Hemorrhage, run by Banc de Sang i Teixits at 1 site in Spain.
Trial summary
This is a single-center, not-randomized, open-label, controlled pilot clinical trial. This study compares presence of Trauma Induced Coagulopathy (TIC) and acute traumatic hemorrhage treatment at pre-hospital phase of care with red blood cells (RBC), Tranexamic acid (TXA) and Fibrinogen Concentrate (FC) with the… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Polytrauma, Traumatic Hemorrhage
- What is being tested?
- Fibrinogen Concentrate (Human) 1 MG [RiaSTAP], Red blood cells concentrate and Tranexamic Acid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteSpain
- Study dates
- 21 Nov 2018to 11 Jan 2022
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years AND
- Patients with severe trauma categorized as priority 0 or 1 according to the CatSalut Polytrauma Code (PPT) AND
- Evidence of bleeding or a high bleeding suspicion according to physician judgment OR
- Predicted to need transfusion according to TICCS score ≥10
Who cannot join
- Moribund patient with devastating injuries and expected to die within 1-hour OR
- Known objection to blood components transfusion OR
- Known acquired or congenital coagulopathies not related to the actual trauma OR
- Known anticoagulant treatment (vitamin K antagonist, dabigatran, rivaroxaban, apixaban) OR
- Known Pregnancy OR
- Severe isolated traumatic brain injury OR
- Hemorrhage not related to the actual trauma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transfusion of Red Blood Cells (RBC), Tranexamic Acid (TXA) and Fibrinogen Concentrate (FC) for Severe Trauma Hemorrhage at Pre-hospital Phase of Care. A Pilot Trial.
This is a single-center, not-randomized, open-label, controlled pilot clinical trial. This study compares presence of Trauma Induced Coagulopathy (TIC) and acute traumatic hemorrhage treatment at pre-hospital phase of care with red blood cells (RBC), Tranexamic acid (TXA) and Fibrinogen Concentrate (FC) with the current treatment based on the administration of Crystalloids and TXA.
Read the detailed description
A pilot, non-randomized, open-label study of two intervention arms and controlled with the standard treatment in which 60 patients affected with acute hemorrhage due to severe trauma will enter the study with the main objective of evaluating the feasibility and the efficacy of early treatment during the pre-hospital care phase with packed red blood cells, fibrinogen concentrate and tranexamic acid (experimental arm) compared to the standard treatment based on crystalloids administration and tranexamic acid (control arm). The secondary objectives are to evaluate the safety and clinical evolution of the patients. Prior to the administration of the treatment, 2 blood samples will be extracted in both groups in order to compare the coagulation status and to be able to perform the pre-transfusion tests. On arrival at the hospital, another sample will be taken to compare changes in coagulation after the administration of the experimental or standard treatment and also between both groups. The assessment of the coagulation status will be made using the values provided by the viscoelastic test (TEG6s). The experimental and standard treatment will be administered endovenously. After treatment, patients will be evaluated up to 30 days.
- Conditions
- Polytrauma, Traumatic Hemorrhage
- Being tested
- Fibrinogen Concentrate (Human) 1 MG [RiaSTAP], Red blood cells concentrate, Tranexamic Acid
- Keywords
- Polytrauma, Red blood cells transfusion, Acute traumatic hemorrhage
- Medical subject headings
- Multiple Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrinogen Concentrate (Human) 1 MG [RiaSTAP]Drug
Administration of 2 mg of FC together with RBC and TXA
Red blood cells concentrateBiological
Administration of 2 red blood cells concentrates together with FC and TXA
Tranexamic AcidDrug
Administration of 1g of TXA together with FC and RBC
| Study group | Role | What they receive |
|---|---|---|
| Experimental treatment | Experimental | The active treatment consists of intravenous injection of 2g of fibrinogen concentrate, 1g of tranexamic acid, 2 red bood cells concentrate O Rh(D) negative (Banc de Sang i Teixits, Barcelona, Spain), and crystalloids at pre-hospital phase of care. Receives: Drug: Fibrinogen Concentrate (Human) 1 MG [RiaSTAP]; Biological: Red blood cells concentrate; Drug: Tranexamic Acid |
| Standard treatment | Active comparator | Patients in the control arm will be treated according the existing protocols based on crystalloids and tranexamic acid administration. Receives: Drug: Tranexamic Acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
TEG6s(R) parameters for Trauma Induced Coagulopathy (TIC)
TEG6s(R) parameters that define TIC
Measured: Basal (at the crash site)
TEG6s(R) parameters for Trauma Induced Coagulopathy (TIC)
TEG6s(R) parameters that define TIC
Measured: Basal (at the hospital arrival)
All-cause mortality
Mortality for any cause
Measured: 1 hour post hospital admission
All-cause mortality
Mortality for any cause
Measured: 6 hours post hospital admission
All-cause mortality
Mortality for any cause
Measured: 24 hours post hospital admission
Accountability
Red bood cells concentrate accountability
Measured: 30 days
Temperature storage conditions of the red blood cells concentrate
Red bood cells concentrate out of temperature range for storage
Measured: 24 hours
Secondary outcomes (11)
All-cause mortality
Mortality for any cause
Measured: 48 hours post hospital admission
All-cause mortality
Mortality for any cause
Measured: 30 days post hospital admission
Adverse Events
Treatment emergent adverse events
Measured: 30 days post hospital admission (or previously at hospital discharge)
Thromboembolism events
Thromboembolism events
Measured: 30 days
Crystalloid fluid requirements
Volume of crystalloids required
Measured: 1 hour (from the crash site to the hospital admission)
Crystalloid fluid requirements
Volume of crystalloids required
Measured: 30 days post hospital admission (or previously at hospital discharge)
Transfusion requirements
Transfusion requirements of RBC, platelets and plasma
Measured: 24 hours (or previously at discharge of the emergency room)
Transfusion requirements
Transfusion requirements of RBC, platelets and plasma
Measured: 30 days post hospital admission (or previously at hospital discharge)
Water balance
Water balance at the Intensive Care Unit (ICU)
Measured: 24 hours of admission at the ICU
Water balance
Water balance at the Intensive Care Unit (ICU)
Measured: 72 hours of admission at the ICU
Ventilator-free days
Ventilator-free days at the ICU
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start21 Nov 2018
- Primary completion11 Jan 2021
- Study completion11 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolytraumaStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, non-randomized, open-label, two-arms, controlled pilot clinical trial. The experimental and control arms will be determined according to the SEM units with RBC, TXA and FC administration capacity (i.e. helicopter unit, rapid intervention ambulance or advanced life support ambulance). The emergency SEM units are activated according current protocols based on distance, severity and weather conditions.
- Masking
- None (open label)
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- Banc de Sang i Teixits
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03780894
- Sponsor's protocol ID
- PRETIC
- Acronym
- PRETIC
- Status last verified
- Jan 2024
- First submitted
- 12 Dec 2018
- Last updated
- 25 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfusion of Red Blood Cells (RBC), Tranexamic Acid (TXA) and Fibrinogen Concentrate (FC) for Severe Trauma Hemorrhage at Pre-hospital Phase of Care. A Pilot Trial.
- ClinicalTrials.gov ID
- NCT03780894
- Acronym / sponsor ID
- PRETIC / PRETIC
- Conditions
- Polytrauma, Traumatic Hemorrhage
- Keywords
- Polytrauma, Red blood cells transfusion, Acute traumatic hemorrhage
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- Banc de Sang i TeixitsUniversity, hospital or other
- Study start
- 21 Nov 2018 (actual)
- Primary completion
- 11 Jan 2021 (actual)
- Study completion
- 11 Jan 2022 (actual)
- First posted
- 19 Dec 2018 (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.
This is a single-center, not-randomized, open-label, controlled pilot clinical trial. This study compares presence of Trauma Induced Coagulopathy (TIC) and acute traumatic hemorrhage treatment at pre-hospital phase of care with red blood cells (RBC), Tranexamic acid (TXA) and Fibrinogen Concentrate (FC) with the current treatment based on the administration of Crystalloids and TXA.
Detailed description
A pilot, non-randomized, open-label study of two intervention arms and controlled with the standard treatment in which 60 patients affected with acute hemorrhage due to severe trauma will enter the study with the main objective of evaluating the feasibility and the efficacy of early treatment during the pre-hospital care phase with packed red blood cells, fibrinogen concentrate and tranexamic acid (experimental arm) compared to the standard treatment based on crystalloids administration and tranexamic acid (control arm). The secondary objectives are to evaluate the safety and clinical evolution of the patients. Prior to the administration of the treatment, 2 blood samples will be extracted in both groups in order to compare the coagulation status and to be able to perform the pre-transfusion tests. On arrival at the hospital, another sample will be taken to compare changes in coagulation after the administration of the experimental or standard treatment and also between both groups. The assessment of the coagulation status will be made using the values provided by the viscoelastic test (TEG6s). The experimental and standard treatment will be administered endovenously. After treatment, patients will be evaluated up to 30 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-center, non-randomized, open-label, two-arms, controlled pilot clinical trial. The experimental and control arms will be determined according to the SEM units with RBC, TXA and FC administration capacity (i.e. helicopter unit, rapid intervention ambulance or advanced life support ambulance). The emergency SEM units are activated according current protocols based on distance, severity and weather conditions.
| Arm | Type | Receives |
|---|---|---|
| Experimental treatment | Experimental | Drug: Fibrinogen Concentrate (Human) 1 MG [RiaSTAP], Biological: Red blood cells concentrate, Drug: Tranexamic AcidThe active treatment consists of intravenous injection of 2g of fibrinogen concentrate, 1g of tranexamic acid, 2 red bood cells concentrate O Rh(D) negative (Banc de Sang i Teixits, Barcelona, Spain), and crystalloids at pre-hospital phase of care. |
| Standard treatment | Active comparator | Drug: Tranexamic AcidPatients in the control arm will be treated according the existing protocols based on crystalloids and tranexamic acid administration. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years AND
- Patients with severe trauma categorized as priority 0 or 1 according to the CatSalut Polytrauma Code (PPT) AND
- Evidence of bleeding or a high bleeding suspicion according to physician judgment OR
- Predicted to need transfusion according to TICCS score ≥10
Key exclusion criteria (7 listed)
- Moribund patient with devastating injuries and expected to die within 1-hour OR
- Known objection to blood components transfusion OR
- Known acquired or congenital coagulopathies not related to the actual trauma OR
- Known anticoagulant treatment (vitamin K antagonist, dabigatran, rivaroxaban, apixaban) OR
- Known Pregnancy OR
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 Concentrate (Human) 1 MG [RiaSTAP]Administration of 2 mg of FC together with RBC and TXA | Drug | Experimental treatment |
| Red blood cells concentrateAdministration of 2 red blood cells concentrates together with FC and TXA | Biological | Experimental treatment |
| Tranexamic AcidAdministration of 1g of TXA together with FC and RBC | Drug | Experimental treatment, Standard treatment |
Primary outcome
TEG6s(R) parameters for Trauma Induced Coagulopathy (TIC)
Time frame: Basal (at the crash site)
TEG6s(R) parameters that define TIC
TEG6s(R) parameters for Trauma Induced Coagulopathy (TIC)
Time frame: Basal (at the hospital arrival)
TEG6s(R) parameters that define TIC
All-cause mortality
Time frame: 1 hour post hospital admission
Mortality for any cause
All-cause mortality
Time frame: 6 hours post hospital admission
Mortality for any cause
All-cause mortality
Time frame: 24 hours post hospital admission
Mortality for any cause
Accountability
Time frame: 30 days
Red bood cells concentrate accountability
Temperature storage conditions of the red blood cells concentrate
Time frame: 24 hours
Red bood cells concentrate out of temperature range for storage
11 secondary outcomes
All-cause mortality
Time frame: 48 hours post hospital admission
All-cause mortality
Time frame: 30 days post hospital admission
Adverse Events
Time frame: 30 days post hospital admission (or previously at hospital discharge)
Thromboembolism events
Time frame: 30 days
Crystalloid fluid requirements
Time frame: 1 hour (from the crash site to the hospital admission)
Crystalloid fluid requirements
Time frame: 30 days post hospital admission (or previously at hospital discharge)
Transfusion requirements
Time frame: 24 hours (or previously at discharge of the emergency room)
Transfusion requirements
Time frame: 30 days post hospital admission (or previously at hospital discharge)
Water balance
Time frame: 24 hours of admission at the ICU
Water balance
Time frame: 72 hours of admission at the ICU
Ventilator-free days
Time frame: 30 days
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 25 Jan 2024.
- Blood and Tissue Bank of CataloniaLink provided by the sponsor.
- HOspital Universitari Dr. Trueta (Girona, Spain)Link provided by the sponsor.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fibrinogen Concentrate (Human) 1 MG [RiaSTAP], Red blood cells concentrate and Tranexamic Acid in people with Polytrauma and Traumatic Hemorrhage, run by Banc de Sang i Teixits at 1 site in Spain.
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 4 inclusion and 7 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 25 Jan 2024. 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 Spain. 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?
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?
TEG6s(R) parameters for Trauma Induced Coagulopathy (TIC) (time frame: Basal (at the crash site)). The study lists 7 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 25 Jan 2024.