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Pre-Hospital Zone 1 Partial Resuscitative Endovascular Balloon Occlusion of the Aorta for Injured Patients With Exsanguinating Sub-diaphragmatic Haemorrhage

NCT04145271 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 10

Last updated 2022-05-09

No results posted yet for this study

Summary

It is unknown whether this evolved strategy (Pre-Hospital Zone I P-REBOA) is feasible and with an acceptable safety profile. This study will address this question, therefore informing the design of a prospective multicentre exploratory cohort study followed by a pilot/feasibility multicenter RCT (IDEAL 2B). The IDEAL Framework is an internationally recognised standard, that describes the stages through which interventional therapy innovation normally passes, the characteristics of each stage and the study design types recommended for each

Conditions

  • Emergencies
  • Trauma Injury
  • Trauma, Multiple

Interventions

DEVICE

Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA)

Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) is a minimally invasive damage control procedure for life-threatening abdominal and/or pelvic haemorrhage. It involves temporary occlusion of the aorta with an endovascular balloon, providing proximal control to the site of vascular injury whilst supporting cerebral and myocardial perfusion

Sponsors & Collaborators

  • Barts & The London NHS Trust

    lead OTHER

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-27
Primary Completion
2022-03-31
Completion
2022-03-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04145271 on ClinicalTrials.gov