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ArticleActa anaesthesiologica Scandinavica2025

Prehospital Treatment With Dried Plasma in Patients With Major Bleeding-A Prospective Randomised Controlled Multicentre Trial: Statistical Analysis Protocol.

G Skallsjö, A Wikman, C Wessman, G Sandström

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in Acta anaesthesiologica Scandinavica, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07012863 (Life-saving Treatment With Dry-plasma for Massive Bleeding in an Pre-hospital Setting - - a Randomized Controlled Study), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT07012863 phase4not yet recruitingnot on this mapstarted 2026, after this paper: background citation

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

TypeinterventionalSponsorVastra Gotaland RegionRan2026 to 2027Enrolled650ConditionsBleeding, Aortic Rupture, Gastrointestinal Hemorrhage, Obstetric BleedingArmsDry plasma
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors.

G SkallsjöHelicopter Emergency Medical Service, Västra Götalandsregionen, Gothenburg, Sweden.
A WikmanDepartment of Clinical Immunology and Transfusion Medicine, Karolinska University Hospital and Department of Medicine, Huddinge, Karolinska Institutet, Stockholm, Sweden.
C WessmanBiostatistics, School of Public Health and Community Medicine, Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
G SandströmDepartment of Anaesthesiology and Intensive Care, Institute of Clinical Sciences, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.ORCID 0000-0001-7352-4356

Funding

Carnegie Foundation, Stockholm SwedenCentre for Disaster Medicine at Gothenburg UniversitySödra Älvsborg Hospital, Västra Götaland RegionSwedish Military Medical Association
6 · The paper itself

Abstract

backgroundMajor haemorrhage remains one of the most preventable causes of early death in prehospital care. While prehospital administration of plasma has shown potential to improve survival, logistical challenges limit its use outside hospitals. Dried plasma offers a practical solution, particularly in rural or remote environments. This statistical analysis protocol (SAP) describes the predefined methods for evaluating the effect of dried plasma versus standard care in bleeding patients treated in the prehospital setting.

methodsThis prospective, randomised parallel trial is registered at ClinicalTrials.gov (NCT07012863) and includes adult patients (≥ 18 years) with suspected bleeding requiring fluid resuscitation. Ambulance vehicles are randomised to either carry dried plasma or standard care (crystalloids), stratified by urban and rural regions. Each ambulance will be reassigned to either standard care or dried plasma after each mission. The primary outcome is 24-h survival. Secondary outcomes include markers of coagulopathy, transfusion volume, and impact of transport time. All analyses follow the intention-to-treat principle and utilize Cox regression, linear or quantile regression, with Bonferroni-Holm adjustment for multiplicity. The trial will enrol a total of 650 patients.

conclusionsThis SAP ensures transparency and prevents analytical bias in a trial that addresses an urgent need for field-appropriate blood products. The results may inform practice and policy for both civilian and military prehospital care.

trial registrationclinicaltrials.gov (NCT07012863).

Indexed as

Emergency Medical ServicesHemorrhagePlasmaAdultAmbulancesFemaleFluid TherapyHumansMaleMulticenter Studies as TopicProspective StudiesRandomized Controlled Trials as Topiccoagulopathydried plasmahaemorrhageprehospital resuscitationrandomised controlled study

Identifiers

PMID40910602
PMCPMC12412280

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.