BleedingPhase 4NCT07012863
Life-saving Treatment With Dry-plasma for Massive Bleeding in an Pre-hospital Setting
A Phase 4 study testing Dry plasma in people with Bleeding and Aortic Rupture, run by Vastra Gotaland Region.
Trial summary
The overall goal of this clinical trial is to study how prehospital transfused dry plasma affect outcomes in terms of mortality as well as complications and coagulation status of patients in or about to develop bleeding shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bleeding, Aortic Rupture, Gastrointestinal Hemorrhage
- What is being tested?
- Dry plasma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 30 Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 clinical signs of bleeding which also triggers resuscitation with crisalloids acording to standard care protocol.
Who cannot join
- Patients < 18 years of age.
- Patients who lack clinical signs of major bleeding.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Life-saving Treatment With Dry-plasma for Massive Bleeding in an Pre-hospital Setting - - a Randomized Controlled Study
The overall goal of this clinical trial is to study how prehospital transfused dry plasma affect outcomes in terms of mortality as well as complications and coagulation status of patients in or about to develop bleeding shock.
Researchers will compare dry plasma to standard care to see if dry plasma improves survival compared to crystalloid fluid in prehospital patients with heavy bleeding.
Read the detailed description
Major haemorrhage remains one of the leading causes of preventable early death after injury, and the window for effective intervention often closes in the pre-hospital phase. Contemporary European guidelines therefore advocate damage-control resuscitation: permissive hypotension, minimal crystalloid use and early infusion of blood components to avoid dilutional coagulopathy, acidosis and hypothermia. Several reports support that early resuscitation with blood products may save lives.
Freeze- or spray dried plasma containing coagulation factors having up to two years storage time and the possibility of storing ambient temperature, may be an alternative to crystalloids. The results regarding the beneficial results of treatment with plasma are ambiguous. In a previous randomized study using fresh plasma versus crystalloids, 9,8% reduced mortality was shown with resuscitation with plasma. Lower INR and lactate were also seen among the patients treated with plasma. In some studies no effect on mortality could be shown, but in other studies it is suggested that plasma may be beneficial in long transport time.
Acute traumatic coagulopathy can be seen in at least 25 % of severely injured patients who are admitted to a trauma centre. Dilution is often considered as a likely cause although the exact mechanisms and level of aggravation is unknown.
Most studies of prehospital bleeding refer to trauma, but also other causes of bleeding can be severe and even fatal, especially in countries with long distances, e.g. obstetric bleeding, gastrointestinal bleeding and vascular catastrophes.
Hypothesis. The hypothesis of this study is that prehospital treatment with dry plasma to bleeding patients improves the outcome compared to patients receiving standard treatment in terms of lower mortality, lower degree of coagulopathy and less need for blood products when in hospital.
Study aim. The aim of this study is to report outcome for patients receiving standard treatment for major prehospital bleeding compared to patients receiving standard care and to report clinical data for both groups.
- Conditions
- Bleeding, Aortic Rupture, Gastrointestinal Hemorrhage, Obstetric Bleeding, Blunt Injury, Penetrating Injury
- Being tested
- Dry plasma
- Medical subject headings
- Hemorrhage, Aortic Rupture, Gastrointestinal Hemorrhage, Wounds, Nonpenetrating, Wounds, Penetrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry plasmaBiological
Patient that fulfil the inclusion criteria for this study and are randomized for active treatment will get dry plasma as intervention.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | Patients randomized to this arm will get standard treatment within the ambulance service |
| Dry plasma | Active comparator | Patients randomized to this arm will get dry plasma as treatment for the bleeding. Receives: Biological: Dry plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Overall mortality at 24 hours after hospital admission. Will include patients dead at scene or during transportation.
Measured: Within 24 hours after hospital admission.
Secondary outcomes (3)
Mortality for patients with bleeding > 500 mL (milliliter)
Specific mortality for patients with a bleeding > 500mL at 24 hours after hospital admission. Will include patients dead at scene or during transport.
Measured: Within 24 hours after hospital admission
Shock Index
Shock Index > 1.3.
Measured: baseline, pre-intervention at scene
Coagulopathy overall
PK/INR > 1.2 and/or Platelet count < 150 x 109/L and/or APTT > 34 s or each valuable alone. INR= international normalized ratio PK= prothrombin complex. APTT= activated partial thromboplastin time.
Measured: Measured at hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start1 Jan 2026 (estimated)
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
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 BleedingStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07012863
- Sponsor's protocol ID
- LBTSB
- Status last verified
- Jan 2025
- First submitted
- 26 May 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Skallsjo G, Wikman A, Wessman C, Sandstrom G. Prehospital Treatment With Dried Plasma in Patients With Major Bleeding-A Prospective Randomised Controlled Multicentre Trial: Statistical Analysis Protocol. Acta Anaesthesiol Scand. 2025 Oct;69(9):e70120. doi: 10.1111/aas.70120.
PubMed 40910602
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Life-saving Treatment With Dry-plasma for Massive Bleeding in an Pre-hospital Setting - - a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07012863
- Acronym / sponsor ID
- LBTSB
- Conditions
- Bleeding, Aortic Rupture, Gastrointestinal Hemorrhage, Obstetric Bleeding, Blunt Injury, Penetrating Injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 10 Jun 2025 (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.
The overall goal of this clinical trial is to study how prehospital transfused dry plasma affect outcomes in terms of mortality as well as complications and coagulation status of patients in or about to develop bleeding shock.
Researchers will compare dry plasma to standard care to see if dry plasma improves survival compared to crystalloid fluid in prehospital patients with heavy bleeding.
Detailed description
Major haemorrhage remains one of the leading causes of preventable early death after injury, and the window for effective intervention often closes in the pre-hospital phase. Contemporary European guidelines therefore advocate damage-control resuscitation: permissive hypotension, minimal crystalloid use and early infusion of blood components to avoid dilutional coagulopathy, acidosis and hypothermia. Several reports support that early resuscitation with blood products may save lives.
Freeze- or spray dried plasma containing coagulation factors having up to two years storage time and the possibility of storing ambient temperature, may be an alternative to crystalloids. The results regarding the beneficial results of treatment with plasma are ambiguous. In a previous randomized study using fresh plasma versus crystalloids, 9,8% reduced mortality was shown with resuscitation with plasma. Lower INR and lactate were also seen among the patients treated with plasma. In some studies no effect on mortality could be shown, but in other studies it is suggested that plasma may be beneficial in long transport time.
Acute traumatic coagulopathy can be seen in at least 25 % of severely injured patients who are admitted to a trauma centre. Dilution is often considered as a likely cause although the exact mechanisms and level of aggravation is unknown.
Most studies of prehospital bleeding refer to trauma, but also other causes of bleeding can be severe and even fatal, especially in countries with long distances, e.g. obstetric bleeding, gastrointestinal bleeding and vascular catastrophes.
Hypothesis. The hypothesis of this study is that prehospital treatment with dry plasma to bleeding patients improves the outcome compared to patients receiving standard treatment in terms of lower mortality, lower degree of coagulopathy and less need for blood products when in hospital.
Study aim. The aim of this study is to report outcome for patients receiving standard treatment for major prehospital bleeding compared to patients receiving standard care and to report clinical data for both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –Patients randomized to this arm will get standard treatment within the ambulance service |
| Dry plasma | Active comparator | Biological: Dry plasmaPatients randomized to this arm will get dry plasma as treatment for the bleeding. |
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 clinical signs of bleeding which also triggers resuscitation with crisalloids acording to standard care protocol.
Key exclusion criteria (2 listed)
- Patients < 18 years of age.
- Patients who lack clinical signs of major bleeding.
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 |
|---|---|---|
| Dry plasmaPatient that fulfil the inclusion criteria for this study and are randomized for active treatment will get dry plasma as intervention. | Biological | Dry plasma |
Primary outcome
Mortality
Time frame: Within 24 hours after hospital admission.
Overall mortality at 24 hours after hospital admission. Will include patients dead at scene or during transportation.
3 secondary outcomes
Mortality for patients with bleeding > 500 mL (milliliter)
Time frame: Within 24 hours after hospital admission
Shock Index
Time frame: baseline, pre-intervention at scene
Coagulopathy overall
Time frame: Measured at hospital admission
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Derived from this study: PubMed 40910602Skallsjo G, Wikman A, Wessman C, Sandstrom G. Prehospital Treatment With Dried Plasma in Patients With Major Bleeding-A Prospective Randomised Controlled Multicentre Trial: Statistical Analysis Protocol. Acta Anaesthesiol Scand. 2025 Oct;69(9):e70120. doi: 10.1111/aas.70120.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dry plasma in people with Bleeding and Aortic Rupture, run by Vastra Gotaland Region.
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 2 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: opening soon, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Göran Sandström, PhD (+46760181284, goran.sandstrom@gu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: Within 24 hours after hospital admission.). 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 NCT07012863, 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 17 Sep 2025.