Life-saving Treatment With Dry-plasma for Massive Bleeding in an Pre-hospital Setting
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dry plasma.
- Who it may be relevant to
- Registry conditions: Bleeding, Aortic Rupture, Gastrointestinal Hemorrhage, Obstetric Bleeding. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Life-saving Treatment With Dry-plasma for Massive Bleeding in an Pre-hospital Setting - - a Randomized Controlled Study
Overview
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.
Interventions
- Biological Dry plasma
Patient that fulfil the inclusion criteria for this study and are randomized for active treatment will get dry plasma as intervention.
Primary outcome measures
- Mortality [Time frame: Within 24 hours after hospital admission.]
Secondary outcome measures (3)
- Mortality for patients with bleeding > 500 mL (milliliter) [Time frame: Within 24 hours after hospital admission]
- Shock Index [Time frame: baseline, pre-intervention at scene]
- Coagulopathy overall [Time frame: Measured at hospital admission]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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
Identifiers
NCT: NCT07012863 · LBTSB