Actively Recruiting
Efficacy of Early Continuous Infusion of HSS on the Neurological Outcome at 6 Months in TBI Patients.
Led by Nantes University Hospital · Updated on 2026-04-29
760
Participants Needed
23
Research Sites
162 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to demonstrate the efficacy of early continuous intravenous infusion of hypertonic saline solution (HSS) to improve survival and independence in daily life activities (at 6 months) of patients with traumatic brain injury at high risk of intracranial hypertension.
CONDITIONS
Official Title
Efficacy of Early Continuous Infusion of HSS on the Neurological Outcome at 6 Months in TBI Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient admitted to intensive care unit
- Traumatic brain injury with Glasgow Coma Scale 64 12
- Intracranial pressure monitoring based on the attending physician's clinical judgment
- Inclusion within the first 12 hours after intracranial pressure monitoring placement
- Informed and signed consent
- National health insurance
You will not qualify if you...
- Glasgow Coma Scale score of 3 with persistent abnormal pupillary reactivity despite urgent therapy
- Associated cervical spinal cord injury
- Imminent death and do-not-resuscitate orders
- Coma secondary to cardiac arrest
- Pregnancy (tested by serum or urine)
- Severe cardiac insufficiency
- Severe chronic renal insufficiency
- Severe hepatic insufficiency with oedemato-ascitic decompensation or Child-Pugh class C cirrhosis
- High risk of follow-up difficulties after ICU discharge
- Patients under court protection
- Patient who does not speak French
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 23 locations
1
CHU d'Angers
Angers, France
Not Yet Recruiting
2
CHU de Brest
Brest, France
Not Yet Recruiting
3
CHU Caen Normandie
Caen, France
Not Yet Recruiting
4
CHU de Clermont- Ferrand
Clermont-Ferrand, France
Not Yet Recruiting
5
Hôpital BEAUJON APHP
Clichy, France
Not Yet Recruiting
6
CHU Henri Mondor APHP
Créteil, France
Not Yet Recruiting
7
CH de Annecy Genevois
Épagny, France
Not Yet Recruiting
8
CHU de Grenoble
Grenoble, France
Not Yet Recruiting
9
CHU de Lille
Lille, France
Not Yet Recruiting
10
HCL
Lyon, France
Not Yet Recruiting
11
AP-HM
Marseille, France
Not Yet Recruiting
12
CHU de Nancy
Nancy, France
Not Yet Recruiting
13
CHU de Nantes
Nantes, France
Actively Recruiting
14
CHU de Nice
Nice, France
Not Yet Recruiting
15
CHU Lariboisière, AP-HP
Paris, France
Not Yet Recruiting
16
GHU Paris Cité
Paris, France
Not Yet Recruiting
17
CHU de Poitiers
Poitiers, France
Not Yet Recruiting
18
CHU de Rennes
Rennes, France
Not Yet Recruiting
19
CHU de Rouen
Rouen, France
Not Yet Recruiting
20
CHU de St- Etienne
Saint-Etienne, France
Not Yet Recruiting
21
CHU de Strasbourg
Strasbourg, France
Not Yet Recruiting
22
CHU de Toulouse
Toulouse, France
Not Yet Recruiting
23
CHRU de Tours
Tours, France
Not Yet Recruiting
Research Team
A
Antoine ROQUILLY
CONTACT
A
Astrid GARREAU
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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