Prehospital Transfusion Strategy in Bleeding Patients

Not Applicable

• Conditions: Hemorrhage; Blood Component Transfusion
• Interventions: Biological: Blood products

• Registration Number: NCT04879485
• Lead Sponsor: University of Aarhus

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. 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. Endothelial function and ability of clot formation is preserved to a greater extent in patients receiving plasma.

Detailed Description

Rationale for the study:

The warranted clinical question to be unsolved is whether initial pre-hospital transfusion in bleeding patients should base on a strategy including plasma, RBC or combination of both.

Despite possible benefits, allogenic blood product are associated with side effects and pose significant logistic challenges in the prehospital environment. So far, a majority of the present knowledge is based on retrospective evaluations or clinical trials without relevant control groups.

Study Timeline

• Study First Submitted: 2021-04-29
• Status Verified: 2021-05
• Study Start: 2021-05-03
• Study First Submitted QC: 2021-05-07
• Study First Posted: 2021-05-10
• Last Update Submitted: 2021-10-05
• Last Update Posted: 2021-10-06
• Primary Completion: 2023-12-31
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Major bleeding requiring prehospital transfusion

Exclusion Criteria

• Transfusion with blood products already initiated

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plasma	Blood products	Transfusion with plasma
Red Blood cells	Blood products	Transfusion with red blood cells

Primary Outcome Measures

Name	Time	Method
Base deficit	At hospital arrival (with in 1 hour)	Arterial-gas analysis upon arrival with parameter base deficit as primary outcome

Secondary Outcome Measures

Name	Time	Method
International Normalized Ratio (INR)	At hospital arrival (with in 2 hours)	Plasma sample analysed; INR
30 days mortality	mortality within 30 days	Mortality, follow up in patient records
Activated Partial Thromboplastin Time (APTT)	At hospital arrival (with in 2 hours)	Plasma sample analysed; APTT
Endogenous thrombin potential (ETP)	At hospital arrival (with in 2 hours)	Plasma sample analysed; thrombin generation assay
Endothelium markers	At hospital arrival (with in 2 hours)	Plasma sample analysed; soluble thrombomodulin
In hospital plasma transfusion requirements	Within in the first 24 hours after hospital arrival	Amount of plasma transfused as registered in patient electronic records
In hospital red blood cell transfusion requirements	Within in the first 24 hours after hospital arrival	Amount of red blood cells transfused as registered in patient electronic records
In hospital platelet transfusion requirements	Within in the first 24 hours after hospital arrival	Amount of platelet transfused as registered in patient electronic records

Trial Locations

Locations (2)

Danish Air Ambulance; 🇩🇰 Aarhus, Denmark

Aarhus Universityhospital; 🇩🇰 Silkeborg, Midtjylland, Denmark