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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Dry plasma
Biological/VaccinePatient that fulfil the inclusion criteria for this study and are randomized for active treatment will get dry plasma as intervention.
Treatment groups
Trial outcomes
Primary outcomes
Mortality
Overall mortality at 24 hours after hospital admission. Will include patients dead at scene or during transportation.
Secondary outcomes
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.
Shock Index
Shock Index \> 1.3.
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.
Locations
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: