Clinical trial • Not applicable • Other

Human plasma for Haemorrhagic shock

Not applicable trial of Human plasma for Haemorrhagic shock.

Overview

Trial Therapeutic Area
Other
Trial Disease
Haemorrhagic shock
Trial Stage
Not applicable
Drug Modality
Other|Small molecule

Key dates

Initial CTIS Submission Date
29-09-2025
First CTIS Authorization Date
26-01-2026

Trial design

ELO-MEL isoton - Infusionslösung (electrolyte solution) infusion; max daily dose 30 millilitre(s)/kilogram; max total dose 40 millilitre(s)/kilogram.-controlled Not applicable trial across 1 site in Austria.

Comparator
ELO-MEL isoton - Infusionslösung (electrolyte solution) infusion; max daily dose 30 millilitre(s)/kilogram; max total dose 40 millilitre(s)/kilogram.
Target Sample Size
30

Eligibility

Recruits 30 Vulnerable population selected (isVulnerablePopulationSelected=true). Subject information and informed consent forms available: 'L1_SIS and ICF_adult' and 'L1_SIS and ICF_adult_representative' (indicating provision for adult representative consent)..

Pregnancy Exclusion
Pregnancy or breastfeeding
Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected=true). Subject information and informed consent forms available: 'L1_SIS and ICF_adult' and 'L1_SIS and ICF_adult_representative' (indicating provision for adult representative consent).

Inclusion criteria

  • {"criterion_text":"- 18 years of age or older"}
  • {"criterion_text":"- Patient in impending or hemorrhagic shock"}
  • {"criterion_text":"- 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

  • {"criterion_text":"- Initial activation of the massive transfusion protocol upon the patient's arrival in the emergency room"}
  • {"criterion_text":"- Known, IgA deficiency"}
  • {"criterion_text":"- Hypersensitivity to plasma"}
  • {"criterion_text":"- Pregnancy or breastfeeding"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- NA","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
30
Recruitment Window Months
34
Consent Approach
Subject information and informed consent forms available: 'L1_SIS and ICF_adult' and 'L1_SIS and ICF_adult_representative' (documents listed in the CTIS record).

Geography

Total Number Of Sites
1
Total Number Of Participants
30

Austria

Earliest CTIS Part Ii Submission Date
07-01-2026
Latest Decision Or Authorization Date
26-01-2026
Processing Time Days
19
Number Of Sites
1
Number Of Participants
30

Sites

Site Name
Johannes Kepler University Linz
Department Name
Uniklinik für Anästhesiologie und operative Intensivmedizin
Contact Person Name
Jens Meier

Sponsor

Primary sponsor

Full Name
Johannes Kepler University Linz
Organisation Type
Educational Institution
Country Of Registered Address
Austria

Investigational products

Investigational Product Name
LyoPlas N - W
Active Substance
Human plasma
Modality
Other
Routes Of Administration
INFUSION
Route
INFUSION
Authorisation Status
Authorised (prodAuthStatus=1)
Investigational Product Name
ELO-MEL isoton - Infusionslösung
Active Substance
Magnesium chloride hexahydrate; Potassium chloride; Sodium chloride; Calcium chloride dihydrate; Sodium acetate trihydrate
Modality
Small molecule
Routes Of Administration
INFUSION
Route
INFUSION
Authorisation Status
Authorised (prodAuthStatus=2; marketing authorisation number 1-19279)
Maximum Dose
max daily 30 millilitre(s)/kilogram; max total 40 millilitre(s)/kilogram

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