TraumaPhase 3TrauCCNCT02750150
Freeze-dried Plasma in the Initial Management of Coagulopathy in Trauma Patients
A Phase 3 study testing Freezed-dried plasma and Fresh-frozen plasma in people with Trauma and Coagulopathy, run by University Hospital, Lille at 1 site in France.
Trial summary
Knowledge and management of bleeding in severe trauma has changed. A specific coagulopathy is present in 40% of cases. It has a very early onset and this coagulopathy is associated with increased mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trauma, Coagulopathy
- What is being tested?
- Freezed-dried plasma and Fresh-frozen plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jul 2013to 17 Apr 2016
- Phase
- Phase 3
- 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
- Emergency
- Trauma patient admitted in participating trauma care centers
- Severe bleeding requiring transfusion with 4 units of red blood cells and 4 emergency plasma.
- Inclusion performed within the first 6 hours after trauma.
Who cannot join
- Patient taking anticoagulants
- Patients who have received hemostatic treatment during transport (tranexamic -acid excluded)
- Minor Patient
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Trial to Evaluate Freezed-dried Plasma in the Initial Management of Coagulopathy in Trauma Patients
Knowledge and management of bleeding in severe trauma has changed. A specific coagulopathy is present in 40% of cases. It has a very early onset and this coagulopathy is associated with increased mortality. It must be detected and treated early, as illustrated by the military medical data, from the Iraq war and civilian medicine. However, fresh frozen plasma (FFP) requires a thawing step.The French army has encouraged the development of a freeze-dried plasma of innovative because viral inactivation and universal blood grouping, well tolerated, with a reduced risk of TRALI. This sophisticated therapeutic product can be administered after 6 minutes of reconstitution without the need for cross-matching. Nevertheless, its used is currently reserved for military purpose in overseas operations and needs to be evaluated for civil use. To this end, the investigators need to evaluate the impact on coagulopathy of an immediate availability of plasma.
- Conditions
- Trauma, Coagulopathy
- Being tested
- Freezed-dried plasma, Fresh-frozen plasma
- Medical subject headings
- Wounds and Injuries, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freezed-dried plasmaDrug
early transfusion of 4 units of freezed dried plasma
Fresh-frozen plasmaDrug
| Study group | Role | What they receive |
|---|---|---|
| Freezed-dried plasma | Experimental | transfusion of 4 units of freezed dried plasma when available in patients at risk pf massive bleeding (transfusion of 4 red blood cells units in the first 6 hours after trauma) Receives: Drug: Freezed-dried plasma |
| Fresh-frozen plasma | Active comparator | transfusion of 4 units of fresh frozen plasma when available in patients at risk pf massive bleeding (transfusion of 4 red blood cells units in the first 6 hours after trauma) Receives: Drug: Fresh-frozen plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
fibrinogen concentration (clauss)
Measured: 45 minutes after the admission on day 1 after trauma
Secondary outcomes (1)
time frame of transfusion of 4 plasma
Measured: time range between the intention to transfuse plasma and the end of transfusion of 4 plasma within the first 6 hours after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2016 (estimated)
- Study start9 Jul 2013
- Primary completion17 Apr 2016
- Study completion17 Apr 2016
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 Hospital, LilleThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie Susen, MD,PhD, Study chair, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02750150
- Sponsor's protocol ID
- 2011_61
- Other IDs
- 2012-A00075-38
- Acronym
- TrauCC
- Status last verified
- Apr 2016
- First submitted
- 5 Apr 2016
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Garrigue D, Godier A, Glacet A, Labreuche J, Kipnis E, Paris C, Duhamel A, Resch E, Bauters A, Machuron F, Renom P, Goldstein P, Tavernier B, Sailliol A, Susen S. French lyophilized plasma versus fresh frozen plasma for the initial management of trauma-induced coagulopathy: a randomized open-label trial. J Thromb Haemost. 2018 Mar;16(3):481-489. doi: 10.1111/jth.13929. Epub 2018 Jan 22.
PubMed 29274254
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial to Evaluate Freezed-dried Plasma in the Initial Management of Coagulopathy in Trauma Patients
- ClinicalTrials.gov ID
- NCT02750150
- Acronym / sponsor ID
- TrauCC / 2011_61
- Conditions
- Trauma, Coagulopathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 9 Jul 2013 (actual)
- Primary completion
- 17 Apr 2016 (actual)
- Study completion
- 17 Apr 2016 (actual)
- First posted
- 25 Apr 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.
Knowledge and management of bleeding in severe trauma has changed. A specific coagulopathy is present in 40% of cases. It has a very early onset and this coagulopathy is associated with increased mortality. It must be detected and treated early, as illustrated by the military medical data, from the Iraq war and civilian medicine. However, fresh frozen plasma (FFP) requires a thawing step.The French army has encouraged the development of a freeze-dried plasma of innovative because viral inactivation and universal blood grouping, well tolerated, with a reduced risk of TRALI. This sophisticated therapeutic product can be administered after 6 minutes of reconstitution without the need for cross-matching. Nevertheless, its used is currently reserved for military purpose in overseas operations and needs to be evaluated for civil use. To this end, the investigators need to evaluate the impact on coagulopathy of an immediate availability of plasma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Freezed-dried plasma | Experimental | Drug: Freezed-dried plasmatransfusion of 4 units of freezed dried plasma when available in patients at risk pf massive bleeding (transfusion of 4 red blood cells units in the first 6 hours after trauma) |
| Fresh-frozen plasma | Active comparator | Drug: Fresh-frozen plasmatransfusion of 4 units of fresh frozen plasma when available in patients at risk pf massive bleeding (transfusion of 4 red blood cells units in the first 6 hours after trauma) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Emergency
- Trauma patient admitted in participating trauma care centers
- Severe bleeding requiring transfusion with 4 units of red blood cells and 4 emergency plasma.
- Inclusion performed within the first 6 hours after trauma.
Key exclusion criteria (4 listed)
- Patient taking anticoagulants
- Patients who have received hemostatic treatment during transport (tranexamic -acid excluded)
- Minor Patient
- Pregnant or breastfeeding women
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 |
|---|---|---|
| Freezed-dried plasmaearly transfusion of 4 units of freezed dried plasma | Drug | Freezed-dried plasma |
| Fresh-frozen plasma | Drug | Fresh-frozen plasma |
Primary outcome
fibrinogen concentration (clauss)
Time frame: 45 minutes after the admission on day 1 after trauma
1 secondary outcome
time frame of transfusion of 4 plasma
Time frame: time range between the intention to transfuse plasma and the end of transfusion of 4 plasma within the first 6 hours after 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 22 Apr 2026.
- Results publication: PubMed 29274254Garrigue D, Godier A, Glacet A, Labreuche J, Kipnis E, Paris C, Duhamel A, Resch E, Bauters A, Machuron F, Renom P, Goldstein P, Tavernier B, Sailliol A, Susen S. French lyophilized plasma versus fresh frozen plasma for the initial management of trauma-induced coagulopathy: a randomized open-label trial. J Thromb Haemost. 2018 Mar;16(3):481-489. doi: 10.1111/jth.13929. Epub 2018 Jan 22.
- 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.
Sophie Susen, MD,PhD study chair
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Freezed-dried plasma and Fresh-frozen plasma in people with Trauma and Coagulopathy, run by University Hospital, Lille at 1 site in France.
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 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: finished, as of the sponsor's last update on 22 Apr 2026. 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 France. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
fibrinogen concentration (clauss) (time frame: 45 minutes after the admission on day 1 after trauma). 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 NCT02750150, 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 22 Apr 2026.