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NCT Number: NCT07012863

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dry plasma

Biological

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Mortality for patients with bleeding > 500 mL (milliliter)

    Time frame: Within 24 hours after hospital admission

    Specific mortality for patients with a bleeding > 500mL at 24 hours after hospital admission. Will include patients dead at scene or during transport.

  2. Shock Index

    Time frame: baseline, pre-intervention at scene

    Shock Index > 1.3.

  3. Coagulopathy overall

    Time frame: Measured at hospital admission

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Gabriel Skallsjö, MD

CONTACT

[email protected]

+46705683196

Göran Sandström, PhD

CONTACT

[email protected]

+46760181284

Sponsors and collaborators

Lead sponsor

Vastra Gotaland Region

Other Gov

Registry information

Official study title

Life-saving Treatment With Dry-plasma for Massive Bleeding in an Pre-hospital Setting - - a Randomized Controlled Study

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 10, 2025
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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