Life-saving Treatment With Dry-plasma for Massive Bleeding in an Pre-hospital Setting

NCT ID: NCT07012863

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 650 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2027-09-30

Brief 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.

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.

Conditions

Bleeding; Aortic Rupture; Gastrointestinal Hemorrhage; Obstetric Bleeding; Blunt Injury; Penetrating Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Standard care

Patients randomized to this arm will get standard treatment within the ambulance service

Group Type: NO_INTERVENTION

No interventions assigned to this group

Dry plasma

Patients randomized to this arm will get dry plasma as treatment for the bleeding.

Group Type: ACTIVE_COMPARATOR

Dry plasma

Intervention Type: BIOLOGICAL

Patient that fulfil the inclusion criteria for this study and are randomized for active treatment will get dry plasma as intervention.

Interventions

Dry plasma

Patient that fulfil the inclusion criteria for this study and are randomized for active treatment will get dry plasma as intervention.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Patients with clinical signs of bleeding which also triggers resuscitation with crisalloids acording to standard care protocol.

Exclusion Criteria

• Patients < 18 years of age.
• Patients who lack clinical signs of major bleeding.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Göran Sandström, PhD

Role: CONTACT

goran.sandstrom@gu.se

+46760181284

Gabriel Skallsjö, MD

Role: CONTACT

gabriel.skallsjo@vgregion.se

+46705683196

References

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.

Reference Type: DERIVED

PMID: 40910602 (View on PubMed)

Other Identifiers

LBTSB

Identifier Type: -

Identifier Source: org_study_id