Impact of Cardiac Blood Flow on Cerebral Blood Flow in Patients With Severe Traumatic Brain Injury

NCT ID: NCT02019810

Last Updated: 2015-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-10-31

Brief Summary

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Severe traumatic brain injury with increased intracranial pressure can lead to decreased cerebral blood flow. Low cerebral blood flow is responsible for secondary lesions, leading to bad prognosis. It is not yet established whether increasing cardiac output in these patients can lead to an increase in cerebral blood flow, although there are some arguments in favor of this hypothesis. The aim of this study is to demonstrate that increasing cardiac output will improve cerebral blood flow in patients with severe traumatic injury and high cerebral pressure.

Detailed Description

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Conditions

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Severe Traumatic Brain Injury With High Cerebral Pressure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Noradrenaline alone

Treatment for 30 minutes with noradrenaline alone

Group Type ACTIVE_COMPARATOR

Norepinephrine

Intervention Type DRUG

Noradrenaline + dobutamine

Treatment with noradrenaline and dobutamine for 30 minutes

Group Type EXPERIMENTAL

Dobutamine and norepinephrine

Intervention Type DRUG

Interventions

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Norepinephrine

Intervention Type DRUG

Dobutamine and norepinephrine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Traumatic brain injury (TBI) with pattern of oligemia (diastolic velocity \< 30cm/second and/or mean velocity \< 45cm/second measured with transcranial doppler or oxygen tissue pressure \< 15mmHg)
* Closed traumatic brain injury
* Isolated TBI or polytraumatism
* Age between 18 and 65 years old
* Affiliated to a social security system

Exclusion Criteria

* Instable episodes of high cerebral pressure
* Craniectomy
* High cerebral pressure without TBI
* No autoregulation
* Current hemorrhagic shock
* Chronic cardiac failure
* Chronic renal failure
* Hyperemia measured with transcranial doppler
* Short life expectancy
* Refused consent from the family
* Protected patients by the law
* Hypersensibility to one of the treatment or sulfites
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Grenoble

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Grenoble University Hospital

Grenoble, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Gilles Francony, MD

Role: CONTACT

0033476766688

Other Identifiers

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2013-003276-13

Identifier Type: -

Identifier Source: org_study_id

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