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

NCT07012863 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: LBTSB
• Study Type: interventional
• Target: 650
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Mortality for patients with bleeding > 500 mL (milliliter)

  Within 24 hours after hospital admission

• Shock Index

  baseline, pre-intervention at scene

• Coagulopathy overall

  Measured at hospital admission

Study Arms (2)

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.

Biological: Dry plasma

Interventions

Dry plasma BIOLOGICAL

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

Dry plasma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Related Publications (1)

• 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.

  PMID: 40910602 DERIVED

MeSH Terms

Conditions

Hemorrhage; Aortic Rupture; Gastrointestinal Hemorrhage; Wounds, Nonpenetrating; Wounds, Penetrating

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Aneurysm, Ruptured; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Aneurysm; Aortic Diseases; Rupture; Wounds and Injuries; Gastrointestinal Diseases; Digestive System Diseases

Central Study Contacts

Göran Sandström, PhD

CONTACT

+46760181284; goran.sandstrom@gu.se

Gabriel Skallsjö, MD

CONTACT

+46705683196; gabriel.skallsjo@vgregion.se

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 10, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: September 17, 2025

Record last verified: 2025-01