A multi-centre randomised controlled trial of pre-hospital administration of packed red blood cells and freeze-dried plasma to patients with low blood pressure after major injuries.

A Multi-Centre Randomised Controlled Trial of Pre-Hospital Blood Product Administration versus Standard Care for Traumatic Haemorrhage - RePHILL (Resuscitation with Pre-HospItaL bLood products)

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-001401-13-GB

Enrollment

490

Registered

2015-12-18

Start date

2016-04-07

Completion date

Unknown

Last updated

2016-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension after trauma, due to haemorrhage MedDRA version: 18.1 Level: PT Classification code 10053476 Term: Traumatic haemorrhage System Organ Class: 10022117 - Injury, poisoning and procedural complications

Interventions

Trade Name: LyoPlas N - w Product Name: LyoPlas N-w Product Code: Lyophilised Plasma LyoPlas N-w (blood group AB) Pharmaceutical Form: Powder and solvent for solution for injection/infusion INN or Pro

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: a. Traumatic injury b. Pre-Hospital Emergency Medical team attend c. Hypotension (SBP =65 years) yes F.1.3.1 Number of subjects for this age range 45

Exclusion criteria

Exclusion criteria: a. Children (known or apparently aged <16 years) b. Refusal of blood product administration; known Jehovah’s Witness c. Pregnancy (known or apparent) d. Isolated head injury

Design outcomes

Primary

Measure	Time frame
Main Objective: Compared to the current standard of care, does resuscitation with blood products improve the quality of resuscitation (measured by venous lactate clearance during the first two hours from randomisation and reduce mortality in trauma patients?;Secondary Objective: a. Compared to standard care, does pre-hospital blood product resuscitation: i. improve blood pressure, heart rate and capillary oxygenation on ED arrival? ii. prolong on-scene time? iii. reduce pre-hospital fluid requirements? iv. reduce in-hospital transfusion requirements? v. reduce trauma-induced coagulopathy? vi. preserve platelet function? vii.reduce deaths within three hours of hospital arrival viii.lead to a greater incidence of transfusion-related complications, particularly acute respiratory distress syndrome? ix.lead to blood product wastage? b. Are outcomes influenced by: i. blunt vs. penetrating injury mechanism? ii. destination? iii. transport mode? iv. lactate on ED arrival? v. ED arrival within one hour of injury? vi. total pre-hospital fluid volume?;Primary end point(s): The primary outcome measure is a composite consisting of episode mortality (from point of recruitment to discharge from initial hospital admission or death) and lactate clearance <20%/hr in the first two hours from randomisation.;Timepoint(s) of evaluation of this end point: Components: 1) Initial lactate clearance: 2h after admission to the Emergency Department (ED) 2) Episode mortality: at time of death or discharge from initial hospital admission	—

Measure

Time frame

Main Objective: Compared to the current standard of care, does resuscitation with blood products improve the quality of resuscitation (measured by venous lactate clearance during the first two hours from randomisation and reduce mortality in trauma patients?;Secondary Objective: a. Compared to standard care, does pre-hospital blood product resuscitation: i. improve blood pressure, heart rate and capillary oxygenation on ED arrival? ii. prolong on-scene time? iii. reduce pre-hospital fluid requirements? iv. reduce in-hospital transfusion requirements? v. reduce trauma-induced coagulopathy? vi. preserve platelet function? vii.reduce deaths within three hours of hospital arrival viii.lead to a greater incidence of transfusion-related complications, particularly acute respiratory distress syndrome? ix.lead to blood product wastage? b. Are outcomes influenced by: i. blunt vs. penetrating injury mechanism? ii. destination? iii. transport mode? iv. lactate on ED arrival? v. ED arrival within one hour of injury? vi. total pre-hospital fluid volume?;Primary end point(s): The primary outcome measure is a composite consisting of episode mortality (from point of recruitment to discharge from initial hospital admission or death) and lactate clearance <20%/hr in the first two hours from randomisation.;Timepoint(s) of evaluation of this end point: Components: 1) Initial lactate clearance: 2h after admission to the Emergency Department (ED) 2) Episode mortality: at time of death or discharge from initial hospital admission

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Secondary

Measure	Time frame
Secondary end point(s): 1) individual components of primary outcome 2) pre-hospital time 3) pre-hospital fluid type and volume 4) on Emergency Department arrival: a) vital signs (systolic blood pressure, heart rate, capillary oxygen saturation) b) venous lactate concentration c) coagulation (measured viscoelastically with rotational thromboelastometery) d) coagulation (INR) e) platelet function (MultiPlate) 5) total blood product receipt at specified time points 6) during initial admission, incidence of: a) acute respiratory distress syndrome b) transfusion-related complications c) organ failure-free days d) mortality at 6 & 24 hours, 7 days and initial hospital admission 7) pre-hospital blood product wastage;Timepoint(s) of evaluation of this end point: 1) As per B1-23-1 2) ED arrival 3) ED arrival 4) (all) ED arrival 4) d) also at 2 and 6 hours after ED arrival 5) 2, 6, 12 and 24 hours from ED arrival 6) (all) at time of death or discharge from initial hospital admission 7) Conclusion of study	—

Measure

Time frame

Secondary end point(s): 1) individual components of primary outcome 2) pre-hospital time 3) pre-hospital fluid type and volume 4) on Emergency Department arrival: a) vital signs (systolic blood pressure, heart rate, capillary oxygen saturation) b) venous lactate concentration c) coagulation (measured viscoelastically with rotational thromboelastometery) d) coagulation (INR) e) platelet function (MultiPlate) 5) total blood product receipt at specified time points 6) during initial admission, incidence of: a) acute respiratory distress syndrome b) transfusion-related complications c) organ failure-free days d) mortality at 6 & 24 hours, 7 days and initial hospital admission 7) pre-hospital blood product wastage;Timepoint(s) of evaluation of this end point: 1) As per B1-23-1 2) ED arrival 3) ED arrival 4) (all) ED arrival 4) d) also at 2 and 6 hours after ED arrival 5) 2, 6, 12 and 24 hours from ED arrival 6) (all) at time of death or discharge from initial hospital admission 7) Conclusion of study

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Countries

United Kingdom

Contacts

Public ContactProfessor Mark Midwinter

Surgical Reconstruction and Microbiology Research Centre

mark.midwinter@uhb.nhs.uk07718863967

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026