Continuous Hyperosomolar Therapy for Traumatic Brain-injured Patients

Summary

Traumatic brain injury (TBI) is a major cause of death and severe prolonged disability. Intracranial hypertension (ICH) is a critical risk factor of bad outcomes after TBI. Continuous infusion of hyperosmolar therapy has been proposed for the prevention or the treatment of ICH. Whether an early administration of continuous hyperosmolar therapy improves long term outcomes is uncertain. The aim of the current study is to assess the efficiency and the safety of continuous hyperosmolar therapy in TBI patients.

The COBI trial is the first randomized controlled trial powered to investigate whether continuous hyperosmolar therapy in TBI patients improve long term recovery.

Hypothesis

Patients treated with early continuous hyperosmolar therapy have reduced morbidity and mortality rates compared to those receiving standard care alone after traumatic brain injury.

Research Questions

1. Does early continuous hyperosmolar therapy reduce morbidity and mortality rates at 3 and 6 months after TBI assessed by the GOSE questionnaire?
2. Does early continuous hyperosmolar therapy prevent intracranial hypertension?

Conditions

• Moderate to Severe Traumatic Brain Injury

Interventions

DRUG

NaCl20% (Continuous hyperosmolar therapy)

Early intravenous administration (\<24 hours after traumatic brain injury) of NaCl20% for a minimal duration of 48 hours (continued for as long as is necessary to prevent intracranial hypertension) 1-hour bolus (15 g if Na+ \< 145 mmol/L; 7.5 g if 145 \< Na+ \< 150 mmol/L; or no bolus) followed by 1 g/hour as long as Na+\< 150 mmol/L, reduced to 0.5 g/L if 150 \< Na+ \< 155 mmol/L, Discontinuation when 155 mmol/L\<Na+

Sponsors & Collaborators

• Nantes University Hospital

  lead OTHER

Principal Investigators

• Olivier Huet, PU-PH · CHU de Brest

• Lasocki Sigismond, PU-PH · University Hospital, Angers

• Thomas Geerraerts, PU-PH · University Hospital, Toulouse

• Francis Remerand, PU-PH · CHU de Tours

• Philippe Seguin, PU-PH · Rennes University Hospital

• Claire Dahyot, PU-PH · CHU Poitiers

• Pierre François Perrigault, PU-PH · University Hospital, Montpellier

• Jean Denis Moyer, PU-PH · AP-HP Beaujon

• Tarek SHARSHAR, PU-PH · AP-HP Saint-Anne

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-10-31

Primary Completion

2020-03-05

Completion

2020-03-05

Countries

• France

Study Locations