search
Back to results

Efficiency of Coupling Targeted Temperature Management to Brain Temperature in Severe Brain Injury (BRAINTTM)

Primary Purpose

Brain Injuries

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
external cooling with the xxxxx device
Sponsored by
Fondation Ophtalmologique Adolphe de Rothschild
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Injuries focused on measuring Temperature targeted management (TTM), close loop, brain temperature, cerebral temperature, systemic temperature, neuroprotection, fever control

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • patients 18 years of age or older
  • hospitalized patient in neuro-resuscitation with peak monitoring with cerebral temperature measurement by an intra-parenchymal sensor (Sophysa®)
  • patient in hyperthermia (TC ≥ 38.5 °c) and in a situation of brain pain

Exclusion Criteria:

  • patient benefiting from a legal protection measure
  • pregnant or breastfeeding woman
  • previous participation in this study

Sites / Locations

  • Hôpital Fondation Adolphe RothschildRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cerebral temperature target

Systemic temperature target

Arm Description

CCT performed by the external cooling device with cerebral temperature target, measured by a intracranial sensor (coupled to the intracranial pressure device)

CCT performed by the external cooling device with systemic temperature target, measured by a bladder sensor (coupled to the vesal probe, according to the standard service protocol).

Outcomes

Primary Outcome Measures

The percentage of time with brain temperature between (36.5 ± 0.5 °C)
The percentage of time during which the measured brain temperature is included in the target temperature range (36.5 ± 0.5 °C), during the maintenance phase (averages comparison).

Secondary Outcome Measures

Full Information

First Posted
May 27, 2019
Last Updated
July 24, 2023
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
search

1. Study Identification

Unique Protocol Identification Number
NCT03967626
Brief Title
Efficiency of Coupling Targeted Temperature Management to Brain Temperature in Severe Brain Injury
Acronym
BRAINTTM
Official Title
Practical Efficiency of Coupling Targeted Temperature Management to Brain Temperature Rather Than Systemic Temperature in Severe Brain Injury (BRAIN TTM)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 27, 2019 (Actual)
Primary Completion Date
February 27, 2024 (Anticipated)
Study Completion Date
November 27, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
In severe brain-injured patients, it is recommended to strictly control the fever in order to limit brain damage (objective of neuroprotection) via the targeted temperature management (TTM). In the guidelines, the target temperature is the systemic temperature, just for practical reasons (brain temperature not being monitored in most polyvalent ICU). However, in NICU, the brain temperature is monitored routinely via the Intra-Cerebral Pressure (ICP) sensor. Since in the febrile brain-injured patients the objective of the TTM is neuroprotection, it would be more appropriate to target temperature control over the cerebral temperature. The objective of this study is to evaluate the efficacy of TTM directly coupled to the brain temperature. Adult patients with brain injury requiring ICP monitoring (Pressio 2, Sophysa France) and fever requiring TTM (cerebral greater than or equal to 38.5 °C) will be enrolled. The TTM will be carried out according to the usual methods of the investigator's service: external cooling devices coupled with cerebral temperature (Artic Sun, Bard France), including two phases: the cooling phase (H0 to H3) and the maintenance phase (from H3 to the end of the cooling). Two groups will be formed. In the interventional group, coupling of the TTM will be carried out to the cerebral temperature. In the control group, coupling of the TTM will be carried out to the systemic temperature measured at the bladder site. The primary outcome will be the percentage of time during which the cerebral temperature will be measured within recommended target temperature range (i.e. 36 to 37 °C) during the maintenance phase (H3 to H12): comparison of averages. Cerebral hemodynamic parameters (ICP, transcranial doppler, and brain tissue oxygen partial pressure if available) will also be collected, in order to be correlated with the delta temperature (cerebral temperature minor systemic temperature). No medical device will be put in place specifically for the need of the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Injuries
Keywords
Temperature targeted management (TTM), close loop, brain temperature, cerebral temperature, systemic temperature, neuroprotection, fever control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
experimental group: CCT (cerebral temperature target) performed by the external cooling device on the TC measured by the PIC/TC sensor (PIC:intracranial pressure) control group: CCT performed by the external cooling device on the TS, measured by a bladder sensor (coupled to the vesal probe, according to the standard service protocol).
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cerebral temperature target
Arm Type
Experimental
Arm Description
CCT performed by the external cooling device with cerebral temperature target, measured by a intracranial sensor (coupled to the intracranial pressure device)
Arm Title
Systemic temperature target
Arm Type
Active Comparator
Arm Description
CCT performed by the external cooling device with systemic temperature target, measured by a bladder sensor (coupled to the vesal probe, according to the standard service protocol).
Intervention Type
Device
Intervention Name(s)
external cooling with the xxxxx device
Intervention Description
external cooling with the xxxxx device
Primary Outcome Measure Information:
Title
The percentage of time with brain temperature between (36.5 ± 0.5 °C)
Description
The percentage of time during which the measured brain temperature is included in the target temperature range (36.5 ± 0.5 °C), during the maintenance phase (averages comparison).
Time Frame
12 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients 18 years of age or older hospitalized patient in neuro-resuscitation with peak monitoring with cerebral temperature measurement by an intra-parenchymal sensor (Sophysa®) patient in hyperthermia (TC ≥ 38.5 °c) and in a situation of brain pain Exclusion Criteria: patient benefiting from a legal protection measure pregnant or breastfeeding woman previous participation in this study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicolas Engrand
Phone
+33148036984
Email
nengrand@for.paris
First Name & Middle Initial & Last Name or Official Title & Degree
Amélie Yavchitz
Phone
+33148036454
Email
ayavchitz@for.paris
Facility Information:
Facility Name
Hôpital Fondation Adolphe Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amélie YAVCHITZ, Dr
Phone
01 48 03 64 54
Email
ayavchitz@for.paris

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficiency of Coupling Targeted Temperature Management to Brain Temperature in Severe Brain Injury

We'll reach out to this number within 24 hrs