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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bleeding; Gastrointestinal Hemorrhage; Aortic Rupture; Penetrating Injury; Blunt Injury; Obstetric Bleeding
• Intervention / Treatment: Biological: Dry plasma

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 Type: Interventional
• Enrollment (Estimated): 650
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Göran Sandström, PhD; Phone Number: +46760181284; Email: goran.sandstrom@gu.se
• Study Contact Backup: Name: Gabriel Skallsjö, MD; Phone Number: +46705683196; Email: gabriel.skallsjo@vgregion.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard care; Patients randomized to this arm will get standard treatment within the ambulance service
Active Comparator: Dry plasma; Patients randomized to this arm will get dry plasma as treatment for the bleeding.	Biological: Dry plasma; Patient that fulfil the inclusion criteria for this study and are randomized for active treatment will get dry plasma as intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Overall mortality at 24 hours after hospital admission. Will include patients dead at scene or during transportation.	Within 24 hours after hospital admission.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Within 24 hours after hospital admission
Shock Index	Shock Index > 1.3.	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 at hospital admission

Collaborators and Investigators

• Sponsor: Vastra Gotaland Region

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: May 26, 2025
• First Submitted That Met QC Criteria: June 4, 2025
• First Posted (Actual): June 10, 2025

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 16, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Wounds and Injuries; Pathologic Processes; Digestive System Diseases; Gastrointestinal Diseases; Rupture; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aneurysm, Ruptured; Pathological Conditions, Signs and Symptoms; Hemorrhage; Gastrointestinal Hemorrhage; Wounds, Nonpenetrating; Wounds, Penetrating; Aortic Rupture
• Other Study ID Numbers: LBTSB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No