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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorVastra Gotaland Region

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients < 18 years of age.

Patients who lack clinical signs of major bleeding.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dry plasma

    Biological/Vaccine

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

Treatment groups

650 Participants
are divided into 2 treatment groups
Group A: Standard careNo intervention 0 interventions
Group B: Dry plasmaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Mortality

Overall mortality at 24 hours after hospital admission. Will include patients dead at scene or during transportation.

Time frame
Within 24 hours after hospital admission.

Secondary outcomes

1

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.

Time frame
Within 24 hours after hospital admission
2

Shock Index

Shock Index \> 1.3.

Time frame
baseline, pre-intervention at scene
3

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.

Time frame
Measured at hospital admission

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: