Clinical trial NCT07012863: Life-saving Treatment With Dry-plasma for Massive Bleeding in an Pre-hospital Setting
Official title: Life-saving Treatment With Dry-plasma for Massive Bleeding in an Pre-hospital Setting - - a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Bleeding
Aortic Rupture
Gastrointestinal Hemorrhage
Obstetric Bleeding
Blunt Injury
Penetrating Injury
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2025-06-10
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Patients with clinical signs of bleeding. The bleeding is estimated by the ambulance personnel as being \> 500mL.

Exclusion Criteria:

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

Primary outcomes:
measure: Mortality
timeFrame: Within 24 hours after hospital admission.
Secondary outcomes:
measure: Mortality for patients with bleeding > 500 mL (milliliter)
timeFrame: Within 24 hours after hospital admission
measure: Shock Index
timeFrame: baseline, pre-intervention at scene
measure: Coagulopathy overall
timeFrame: Measured at hospital admission
Other outcomes:
Locations:
Study officials:
References: