Prehospital Transfusion Strategy in Bleeding Patients

NCT04879485 | Completed

• 1 other identifier: 1-10-72-289-20
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

The aim of study is to compare clinical and biochemical effect of three different transfusion strategies among patients with major hemorrhage requiring prehospital transfusion. A) Present prehospital standard treatment including a mixture of plasma and Red blood cell transfusion (RBC) transfusion B) Red blood cell transfusion (RBC) only C) Plasma transfusion only Hypothesis:

1. 1.Transfusion strategy including a mixture of RBC and plasma is superior as compared with only plasma or only RBC strategy in terms of initial treatment of circulatory shock (expressed as base deficit).
2. 2.Endothelial function and ability of clot formation is preserved to a greater extent in patients receiving plasma.

Conditions

Hemorrhage; Blood Component Transfusion

Outcome Measures

Primary Outcomes (1)

• Base deficit

  Arterial-gas analysis upon arrival with parameter base deficit as primary outcome

  At hospital arrival (with in 1 hour)

Secondary Outcomes (9)

• 30 days mortality

  mortality within 30 days

• Activated Partial Thromboplastin Time (APTT)

  At hospital arrival (with in 2 hours)

• Endogenous thrombin potential (ETP)

  At hospital arrival (with in 2 hours)

• International Normalized Ratio (INR)

  At hospital arrival (with in 2 hours)

• Endothelium markers

  At hospital arrival (with in 2 hours)

Study Arms (3)

Standard transfusion

NO INTERVENTION

Includes standard transfusion with a mixture of red blood cells and plasma

Plasma

ACTIVE COMPARATOR

Transfusion with plasma

Biological: Blood products

Red Blood cells

ACTIVE COMPARATOR

Transfusion with red blood cells

Biological: Blood products

Interventions

Blood products BIOLOGICAL

Compare two different transfusion strategies against standard transfusion regimen

Plasma; Red Blood cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Major bleeding requiring prehospital transfusion

You may not qualify if:

• Transfusion with blood products already initiated

Sponsors & Collaborators

• University of Aarhus: lead
• Norwegian Air Ambulance Foundation: collaborator
• Odense University Hospital: collaborator
• Copenhagen University Hospital, Denmark: collaborator

Study Sites (2)

Aarhus Universityhospital

Silkeborg, Central Jutland, 8600, Denmark

Location

Danish Air Ambulance

Aarhus, Denmark

Location

Related Publications (1)

• Radford M, Estcourt LJ, Sirotich E, Pitre T, Britto J, Watson M, Brunskill SJ, Fergusson DA, Doree C, Arnold DM. Restrictive versus liberal red blood cell transfusion strategies for people with haematological malignancies treated with intensive chemotherapy or radiotherapy, or both, with or without haematopoietic stem cell support. Cochrane Database Syst Rev. 2024 May 23;5(5):CD011305. doi: 10.1002/14651858.CD011305.pub3.

  PMID: 38780066 DERIVED

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christian Fenger-Eriksen

  Aarhus Universityhospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2021
• First Posted: May 10, 2021
• Study Start: May 3, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: November 18, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)