NCT01374633 (SEPIA) is a Phase 2 clinical trial of 1: Sevoflurane in Brain Injury, sponsored by Assistance Publique - Hôpitaux de Paris.

Who is sponsoring NCT01374633?

NCT01374633 is sponsored by Assistance Publique - Hôpitaux de Paris.

What drugs are being tested in NCT01374633?

Interventions in NCT01374633: 1: Sevoflurane.

What condition does NCT01374633 study?

NCT01374633 studies Brain Injury.

Is NCT01374633 still recruiting?

NCT01374633 is currently terminated. Last updated 26 March 2015.

Last reviewed 2015-03-26 · How we verify

NCT01374633: SEPIA

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Effect on Sevoflurane Sedation on Intra Cranial Pressure in Traumatic Brain Injury Patients

Terminated Phase 2 Last updated 26 March 2015

What this trial tests

Phase 2 trial testing 1: Sevoflurane in Brain Injury in 10 participants. Terminated before completion.

Timeline

1 December 2011

Primary endpoint
1 March 2013

1 March 2013

Quick facts

Lead sponsor	Assistance Publique - Hôpitaux de Paris
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	1 December 2011
Primary completion	1 March 2013
Estimated completion	1 March 2013
Sites	1 location across France

Drugs / interventions tested

1: Sevoflurane

Conditions studied

Brain Injury — all drugs for Brain Injury →

Sponsor

Assistance Publique - Hôpitaux de Paris — full company profile →

Who can join

18 and older, any sex, with Brain Injury. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

ICP evolution
Time frame: ICP will be continuously recorded during the 12 hours of sedation with sevoflurane
patients where ICP increase more than 30 mmHg during more than 15 minutes will be characterized as "failure". Patients whose ICP do not increase during the 12 hours of sedation with sevoflurane will be characterized as "success".

Sponsor's own description

Main purpose of the study is to evaluate the effect of sevoflurane on intra cranial pressure (ICP) after traumatic brain injury. Patients admitted for traumatic brain injury equipped with ICP measurement will be sedated with sevoflurane via the Anaconda device during 12 hours. Sedation will be controlled with BIS.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Brain Injury

Currently open trials in the same condition.

NCT06988787 — Multifaceted Intervention to Restore Resilience and Overcome Risk · NA · recruiting
NCT06930716 — Paired Vagus Nerve Stimulation in Mobilization of Patients With Prolonged Disorders of Consciousness · NA · recruiting
NCT06979466 — Q Therapeutic System for Chronic Stroke Recovery · NA · recruiting
NCT06895109 — Cognitive Functions in Severe Acquired Brain Injury After Cranioplasty · active not recruiting
NCT06898242 — Early Myofascial Manual Treatment in Subjects With Spasticity Following Acquired Brain Injury · NA · active not recruiting

Other Assistance Publique - Hôpitaux de Paris trials

Trials by the same sponsor.

NCT07443436 — Immunomodulatory Treatment of Interstitial Lung Disease Associated With Surfactant Related Gene Variants · Phase 2 · not yet recruiting
NCT07499492 — Red Blood Cell Transfusion to Optimize Extubation · NA · not yet recruiting
NCT07379918 — Real-life Evaluation of Endopredict® in Early HR+/HER2- Breast Cancer · recruiting
NCT07473869 — Smartphone Application for Automated Measurement of Capillary Refill Time (CRT) · not yet recruiting
NCT07505394 — Efficacy of a Prediction Model-based Algorithm to PREVENT Drug-induced Impulse Control Disorders in Parkinson's Disease · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01374633 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris
Last refreshed: 26 March 2015

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01374633.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing