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COntrolled MAp Trauma Brain Injury (COMAT Study)

NCT03792581 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2019-05-14

No results posted yet for this study

Summary

The goal of this randomized controlled trial will be to show that the use of a novel automated system to guide vasopressor administration in head trauma injury patients will results in more time spent with a mean arterial pressure (MAP) within the predefined MAP compared to patients managed without any automated system (manually management)

Conditions

  • Closed-Loop Communication

Interventions

DEVICE

EV1000 and closed-loop system

This system will recommend when patients need fluid or not and adjust vasopressor administration automatically

Sponsors & Collaborators

Principal Investigators

  • Jacques Duranteau, PhD · APHP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2019-12-30
Completion
2019-12-30

Countries

  • France

Study Locations

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Entities

Companies

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 NCT03792581 on ClinicalTrials.gov