Overview
Sponsor-declared trial summary
Haemorrhagic shock
The aim of this study is to investigate whether the early administration of lyophilized plasma in the emergency room represents a better alternative to conventional crystalloid infusion solutions for patients in hemorrhagic shock. We hypothesize that lyophilized plasma, due to its significantly shorter application ti…
Key facts
- Sponsor
- Johannes Kepler University Linz
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
- Trial duration
- 14 Mar 2026 → ongoing
- Decision date (initial)
- 2026-01-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
The aim of this study is to investigate whether the early administration of lyophilized plasma in the emergency room represents a better alternative to conventional crystalloid infusion solutions for patients in hemorrhagic shock.
We hypothesize that lyophilized plasma, due to its significantly shorter application time (lyophilized plasma: 6.5 minutes; conventional plasma: approximately 30–45 minutes), its positive effects on the endothelium, and its sustained volume effect, leads to faster hemodynamic stabilization. The normalization of lactate levels (< 2 mmol/L) will be used as a surrogate parameter for this. Furthermore, we expect that the use of lyophilized plasma will significantly reduce the required amount of crystalloid infusion solutions, thereby avoiding potential side effects associated with volume overload.
Conditions and MedDRA coding
Haemorrhagic shock
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- 18 years of age or older; Patient in impending or hemorrhagic shock; Definition of hemorrhagic shock in this study: Obvious or suspected blood loss Systolic arterial blood pressure ≤90 mmHg or arterial hypotension requiring vasopressor administration Serum lactate concentration ≥2 mmol/L
Exclusion criteria 1
- Initial activation of the massive transfusion protocol upon the patient's arrival in the emergency room Known, IgA deficiency, Hypersensitivity to plasma, Pregnancy or breastfeeding
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- NA
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
PRD12904526 · Product
- Active substance
- Human Plasma
- Substance synonyms
- PLASMA, HUMAN
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 0 millilitre(s)/kilogram
- Max total dose
- 0 ml millilitre(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- JOHANNES KEPLER UNIVERSITY
- Paediatric formulation
- No
- Orphan designation
- No
Comparator 1
ELO-MEL isoton - Infusionslösung
PRD11870367 · Product
- Active substance
- Magnesium Chloride Hexahydrate
- Substance synonyms
- MAGNESIUM CHLORIDE HEXAHYDRATE (E511)
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 30 millilitre(s)/kilogram
- Max total dose
- 40 millilitre(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- B05BB01 — ELECTROLYTES
- Marketing authorisation
- 1-19279
- MA holder
- FRESENIUS KABI AUSTRIA GMBH
- MA country
- Austria
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Johannes Kepler University Linz
- Sponsor organisation
- Johannes Kepler University Linz
- Address
- Med Campus III, Krankenhausstrasse 9 Krankenhausstrasse 9
- City
- Linz
- Postcode
- 4020
- Country
- Austria
Scientific contact point
- Organisation
- Johannes Kepler University Linz
- Contact name
- Dr. med. Dominik Jenny
Public contact point
- Organisation
- Johannes Kepler University Linz
- Contact name
- Martin Ziermayr
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Austria | Ongoing, recruiting | 30 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Austria | 2026-03-14 | 2026-03-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol EU CT- 2025-523151-66-00_for_publication | 1 |
| Protocol (for publication) | D1_Protocol EU CT- 2025-523151-66-00_non_for_publication | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_adult | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF_adult_representative | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC LyoPlas N-w | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_ELO-MEL_isoton | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis DE_EU CT 2025_523151_66_00 | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-09-29 | Austria | Acceptable 2026-01-26
|
2026-01-26 |