NCT03143751

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
370

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 8, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

October 31, 2017

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 5, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 5, 2020

Completed
Last Updated

December 8, 2020

Status Verified

December 1, 2020

Enrollment Period

2.3 years

First QC Date

April 28, 2017

Last Update Submit

December 4, 2020

Conditions

Moderate to Severe Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

  • Score on the Extended Glasgow Outcome Scale (GOS-E) at 6 months

    The GOS-E is a scale measuring the neurological recovery after traumatic brain injuries

    6 months

Secondary Outcomes (23)

  • Mortality rate in ICU

    3 months

  • Mortality rate in ICU

    6 months

  • GOS-E

    3 months

  • functional independence measure : ADL (Activities of Daily Living) of Katz

    3 months

  • functional independence measure : ADL (Activities of Daily Living) of Katz

    6 months

  • +18 more secondary outcomes

Study Arms (2)

Continuous hyperosmolar therapy

EXPERIMENTAL

Standard cares plus continuous hyperosmolar therapy (NaCl20%)

Drug: NaCl20% (Continuous hyperosmolar therapy)

Control

NO INTERVENTION

Standard cares alone.

Interventions

NaCl20% (Continuous hyperosmolar therapy)DRUG

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+

Continuous hyperosmolar therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • Moderate to severe traumatic brain injury defined as the association of a Coma Glasgow Scale ≤ 12 together with a traumatic abnormal brain CT-scan
  • Informed consent (or emergency procedure)

You may not qualify if:

  • dependence for daily activity
  • Coma Glasgow Scale of 3 and fixed dilated pupils
  • associated cervical spine injury
  • imminent death and do-not-resuscitate orders
  • pregnancy.
  • Major not legally responsible
  • Oedemato-ascitic decompensation of hepatic cirrhosis
  • State of hydro-sodium retention secondary to heart failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

CHU Angers

Angers, France

Location

CHU Brest Hopital La Cavale Blanche

Brest, 29600, France

Location

AP-HP Beaujon

Clichy, 92118, France

Location

CHU Montpellier

Montpellier, France

Location

CHU de Nantes

Nantes, 44093, France

Location

Centre Hospitalier Sainte-Anne

Paris, 75014, France

Location

CHU Poitiers

Poitiers, 86000, France

Location

CHU Rennes-Hopital Pontchaillou

Rennes, France

Location

CHU Toulouse Hôpital Pierre-Paul Riquet

Toulouse, 31059, France

Location

CHU Tours

Tours, 37044, France

Location

Related Publications (3)

  • Huet O, Chapalain X, Vermeersch V, Moyer JD, Lasocki S, Cohen B, Dahyot-Fizelier C, Chalard K, Seguin P, Hourmant Y, Asehnoune K, Roquilly A; Atlanrea Study Group and the Societe Francaise d'Anesthesie Reanimation (SFAR) Research Network. Impact of continuous hypertonic (NaCl 20%) saline solution on renal outcomes after traumatic brain injury (TBI): a post hoc analysis of the COBI trial. Crit Care. 2023 Jan 27;27(1):42. doi: 10.1186/s13054-023-04311-1.

    PMID: 36707841DERIVED

  • Roquilly A, Moyer JD, Huet O, Lasocki S, Cohen B, Dahyot-Fizelier C, Chalard K, Seguin P, Jeantrelle C, Vermeersch V, Gaillard T, Cinotti R, Demeure Dit Latte D, Mahe PJ, Vourc'h M, Martin FP, Chopin A, Lerebourg C, Flet L, Chiffoleau A, Feuillet F, Asehnoune K; Atlanrea Study Group and the Societe Francaise d'Anesthesie Reanimation (SFAR) Research Network. Effect of Continuous Infusion of Hypertonic Saline vs Standard Care on 6-Month Neurological Outcomes in Patients With Traumatic Brain Injury: The COBI Randomized Clinical Trial. JAMA. 2021 May 25;325(20):2056-2066. doi: 10.1001/jama.2021.5561.

    PMID: 34032829DERIVED

  • Roquilly A, Lasocki S, Moyer JD, Huet O, Perrigault PF, Dahyot-Fizelier C, Seguin P, Sharshar T, Geeraerts T, Remerand F, Feuillet F, Asehnoune K; COBI group. COBI (COntinuous hyperosmolar therapy for traumatic Brain-Injured patients) trial protocol: a multicentre randomised open-label trial with blinded adjudication of primary outcome. BMJ Open. 2017 Sep 24;7(9):e018035. doi: 10.1136/bmjopen-2017-018035.

    PMID: 28947465DERIVED

Study Officials

  • Olivier Huet, PU-PH

    CHU de Brest

    PRINCIPAL INVESTIGATOR

  • Lasocki Sigismond, PU-PH

    University Hospital, Angers

    PRINCIPAL INVESTIGATOR

  • Thomas Geerraerts, PU-PH

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

  • Francis Remerand, PU-PH

    CHU de Tours

    PRINCIPAL INVESTIGATOR

  • Philippe Seguin, PU-PH

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

  • Claire Dahyot, PU-PH

    CHU Poitiers

    PRINCIPAL INVESTIGATOR

  • Pierre François Perrigault, PU-PH

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

  • Jean Denis Moyer, PU-PH

    AP-HP Beaujon

    PRINCIPAL INVESTIGATOR

  • Tarek SHARSHAR, PU-PH

    AP-HP Saint-Anne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Masking: Open label , Masked Roles: Subject and Outcomes assessor
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 28, 2017

First Posted

May 8, 2017

Study Start

October 31, 2017

Primary Completion

March 5, 2020

Study Completion

March 5, 2020

Last Updated

December 8, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(10)