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Clinical Trials/EUCTR2015-001401-13-GB
EUCTR2015-001401-13-GB
Active, not recruiting
Phase 1

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)

niversity Hospitals Birmingham NHS Foundation Trust0 sites490 target enrollmentDecember 18, 2015
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DrugsLyoPlas N - w

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
niversity Hospitals Birmingham NHS Foundation Trust
Enrollment
490
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 18, 2015
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
niversity Hospitals Birmingham NHS Foundation Trust

Eligibility Criteria

Inclusion Criteria

  • •a. Traumatic injury
  • •b. Pre\-Hospital Emergency Medical team attend
  • •c. Hypotension (SBP \<90mmHg or absence of palpable radial pulse) believed to be due to traumatic haemorrhage.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range: 45
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range 400
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 45

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

Outcomes

Primary Outcomes

Not specified

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