Traumatic Brain InjuryPhase 3DEXCON-TBINCT04303065
Trial of Dexamethasone for Traumatic Brain Injured Patients With Brain Contusions and Pericontusional Edema
A Phase 3 study testing Dexamethasone Oral in people with Traumatic Brain Injury and Cerebral Edema, run by Jon Pérez Bárcena at 1 site in Spain.
Trial summary
The DEXCON-TBI trial is a multicenter, pragmatic, randomized, triple-blind, placebo controlled trial to quantify the effects of the administration of dexamethasone on the prognosis of TBI patients with brain contusions and pericontusional edema. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Traumatic Brain Injury, Cerebral Edema, Head Injury Trauma
- What is being tested?
- Dexamethasone Oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteSpain
- Study dates
- 24 Jul 2020to 1 Dec 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Patients who have suffered a head injury and have one or more cerebral contusions with visible pericontusional edema in the CT scan.
- Patients with brain contusions in whom non-sugical treatment has been selected initially.
- Age 18 or over and under 85
- Signing of informed consent by the patient or by his legal representative. The fundamental eligibility criterion is the responsible clinician's 'uncertainty' as to whether or not to use dexamethasone in a particular patient with TBI. This pragmatic approach will allow us to see whether the intervention improves patient outcomes under real-life conditions.
Who cannot join
- Patients with TBI and brain contusions who have required surgery to evacuate the cerebral contusion before randomization.
- Patients with TBI who have required a craniotomy before randomization for any other reason: evacuation of subdural, epidural hematoma or depressed skull fracture.
- Patients with an extracranial Injury Severity Score greater than 18 points.
- Patients in whom the use of corticosteroids is contraindicated.
- Patients who take oral corticosteroids chronically.
- Patients included in another clinical trial.
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- Known intolerance or hypersensitivity to dexamethasone.
- Patients with allergy or intolerance to the following excipients contained in dexamethasone / placebo capsules: lactose, corn starch or microcrystalline cellulose.
- Patients with a history of psychotic disorders.
- Patients with inability to take medication orally due to swallowing problems in which it is not indicated to place a nasogastric tube.
- Pregnant or breastfeeding patients.
- Patients in a GCS 3 points situation with bilateral dilated pupils.
- Patients with associated spinal cord injuries.
- Patient with any systemic condition that contraindicates the use of corticosteroids.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Universitari Son Espases
Palma de Mallorca, Balearic Islands, 07120
About this study
Official title: Dexamethasone for the Treatment of Traumatic Brain Injured Patients With Brain Contusions and Pericontusional Edema: Study Protocol for a Prospective, Randomized and Double Blind Trial.
The DEXCON-TBI trial is a multicenter, pragmatic, randomized, triple-blind, placebo controlled trial to quantify the effects of the administration of dexamethasone on the prognosis of TBI patients with brain contusions and pericontusional edema. Adult patients who fulfil the elegibility criteria will be randomized to receive dexamethasone or placebo. Patients who have suffered a head injury and have one or more cerebral contusions with visible pericontusional edema in the CT scan can be included in the study. The doses of dexamethasone will be a short and descending course: 4mg/6 hours (2 days); 4 mg/8 hours (2 days); 2 mg/6 hours (2 days); 2 mg/8 hours (2 days); 1 mg/8 hours (2 days); 1 mg/12 hours (2 days). The primary outcome is the Glasgow Scale Outcome Extended (GOSE) performed one month and 6 months after trauma. Other secondary outcomes are: compare the number of episodes of neurological deterioration; compare the symptoms associated with TBI; compare the presence of adverse events during treatment; compare the volume of pericontusional edema before and after 12 days of treatment in both groups of patients; and compare the results of the neuropsychological tests between the two groups of patients one month and 6 months after the TBI. The main analysis will be on an ''intention-to-treat´´ basis. A descriptive analysis of the baseline variables will be made for each treatment group. Logistic regression will be used to estimate the effect of dexamethasone and placebo on GOSE at one month and at 6 months, dichotomized in unfavorable outcome (GOSE 1-6) and favorable outcome (GOSE 7-8). Since the severity of the initial injury will determine significantly the final outcome of the patient, to assess the effect of dexamethasone, efficacy will also be analyzed using the 'sliding dichotomy'. A subgroup analysis will be carried out by stratifying the patients as they present more or less than 10mL of pericontusional edema in the preinclusion CT. We will perform an interim analysis with the patients included during the first year to calculate the conditional power. An independent statistician will blindly perform this analysis. At the same time a safety analysis will be also perfomed. A study with 600 patients would have about 80% power (two sided alpha=5%) to detect a 12% absolute increased (from 50% to 62%) in good outcome.
- Conditions
- Traumatic Brain Injury, Cerebral Edema, Head Injury Trauma
- Being tested
- Dexamethasone Oral, Placebo oral tablet
- Keywords
- traumatic, brain, injury, contusion, edema, steroids
- Medical subject headings
- Brain Injuries, Traumatic, Brain Edema, Wounds and Injuries, Contusions, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone OralDrug
It will be a short and descending course of oral dexamethasone: 4mg/6 hours (2 days); 4 mg/8 hours (2 days); 2 mg/6 hours (2 days); 2 mg/8 hours (2 days); 1 mg/8 hours (2 days); 1 mg/12 hours (2 days).
Placebo oral tabletDrug
The preparation and conditioning of the placebo capsules will be carried out following the standardized work procedures of the pharmaceutical laboratory and its quality controls, previously authorized by the Agencia Española del Medicamento (AEMPS).
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | Dexamethasone will be a short and descending course: 4mg/6 hours (2 days); 4 mg/8 hours (2 days); 2 mg/6 hours (2 days); 2 mg/8 hours (2 days); 1 mg/8 hours (2 days); 1 mg/12 hours (2 days).
Dexamethasone (Fortecortin®) will be acquired from ERN, SA. Laboratories (Barcelona, Spain). The Son Espases Pharmacy Department will be in charge of developing and conditioning the 4mg, 2mg and 1mg dexamethasone / placebo capsules needed for 12 days of treatment, keeping the researchers blind Receives: Drug: Dexamethasone Oral |
| Control | Placebo comparator | The preparation and conditioning of the capsules will be carried out following the standardized work procedures of the pharmaceutical laboratory and its quality controls, previously authorized by the Agencia Española del Medicamento (AEMPS).
The Son Espases Pharmacy Department will be responsible for identifying the containers and sending them by courier to the participating hospitals. A record of the dispensing of test samples will be kept and will be sent in acknowledgment of receipt for control Receives: Drug: Placebo oral tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glasgow Scale Outcome Extended (GOSE).
Measured: one month
Secondary outcomes (5)
Number of episodes of neurological deterioration in both groups of patients during the 12 days of treatment.
Measured: 14 days
Symptoms associated with TBI in both groups of patients during the 12 days of treatment.
Measured: 14 days
Volume of pericontusional edema before and after 12 days of treatment in both groups of patients.
Measured: 14 days
Presence of adverse events between the two groups during the 12 days of treatment.
Measured: 14 days
Neuropsychological tests between the two groups of patients one month and 6 months after the TBI.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start24 Jul 2020
- Primary completion30 Jun 2025
- Study completion1 Dec 2025
Why it stopped: The study was stopped because of lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jon Pérez Bárcena
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Mutua Madrileña, Sociedad Española de Medicina Intensiva, Crítica y Unidades Coronarias (SEMICYUC)
- Responsible party
- Sponsor-investigator, Jon Pérez Bárcena, Hospital Son Espases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04303065
- Sponsor's protocol ID
- 2019-004038-41
- Other IDs
- 2019
- Acronym
- DEXCON-TBI
- Status last verified
- Feb 2026
- First submitted
- 5 Mar 2020
- Last updated
- 6 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Moll A, Lara M, Pomar J, Orozco M, Frontera G, Llompart-Pou JA, Moratinos L, Gonzalez V, Ibanez J, Perez-Barcena J. Effects of dexamethasone in traumatic brain injury patients with pericontusional vasogenic edema: A prospective-observational DTI-MRI study. Medicine (Baltimore). 2020 Oct 23;99(43):e22879. doi: 10.1097/MD.0000000000022879.
PubMed 33120830Lara M, Moll A, Mas A, Picado MJ, Gassent C, Pomar J, Llompart-Pou JA, Brell M, Ibanez J, Perez-Barcena J. Use of diffusion tensor imaging to assess the vasogenic edema in traumatic pericontusional tissue. Neurocirugia (Engl Ed). 2020 Jul 21:S1130-1473(20)30080-4. doi: 10.1016/j.neucir.2020.05.002. Online ahead of print. English, Spanish.
PubMed 32709492Perez-Barcena J, Castano-Leon AM, Lagares Gomez-Abascal A, Barea-Mendoza JA, Navarro Main B, Pomar Pons J, Perianez Parraga LDM, Ibanez Dominguez J, Chico-Fernandez M, Llompart-Pou JA, Frontera Juan G; DEXCON TBI trial collaborators. Dexamethasone for the treatment of traumatic brain injured patients with brain contusions and pericontusional edema: Study protocol for a prospective, randomized and double blind trial. Medicine (Baltimore). 2021 Jan 22;100(3):e24206. doi: 10.1097/MD.0000000000024206.
PubMed 33546038
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexamethasone for the Treatment of Traumatic Brain Injured Patients With Brain Contusions and Pericontusional Edema: Study Protocol for a Prospective, Randomized and Double Blind Trial.
- ClinicalTrials.gov ID
- NCT04303065
- Acronym / sponsor ID
- DEXCON-TBI / 2019-004038-41
- Conditions
- Traumatic Brain Injury, Cerebral Edema, Head Injury Trauma
- Keywords
- traumatic, brain, injury, contusion, edema, steroids
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was stopped because of lack of funding
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Jon Pérez BárcenaUniversity, hospital or other
- Collaborators
- Fundación Mutua Madrileña, Sociedad Española de Medicina Intensiva, Crítica y Unidades Coronarias (SEMICYUC)
- Study start
- 24 Jul 2020 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 10 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The DEXCON-TBI trial is a multicenter, pragmatic, randomized, triple-blind, placebo controlled trial to quantify the effects of the administration of dexamethasone on the prognosis of TBI patients with brain contusions and pericontusional edema. Adult patients who fulfil the elegibility criteria will be randomized to receive dexamethasone or placebo. Patients who have suffered a head injury and have one or more cerebral contusions with visible pericontusional edema in the CT scan can be included in the study. The doses of dexamethasone will be a short and descending course: 4mg/6 hours (2 days); 4 mg/8 hours (2 days); 2 mg/6 hours (2 days); 2 mg/8 hours (2 days); 1 mg/8 hours (2 days); 1 mg/12 hours (2 days). The primary outcome is the Glasgow Scale Outcome Extended (GOSE) performed one month and 6 months after trauma. Other secondary outcomes are: compare the number of episodes of neurological deterioration; compare the symptoms associated with TBI; compare the presence of adverse events during treatment; compare the volume of pericontusional edema before and after 12 days of treatment in both groups of patients; and compare the results of the neuropsychological tests between the two groups of patients one month and 6 months after the TBI. The main analysis will be on an ''intention-to-treat´´ basis. A descriptive analysis of the baseline variables will be made for each treatment group. Logistic regression will be used to estimate the effect of dexamethasone and placebo on GOSE at one month and at 6 months, dichotomized in unfavorable outcome (GOSE 1-6) and favorable outcome (GOSE 7-8). Since the severity of the initial injury will determine significantly the final outcome of the patient, to assess the effect of dexamethasone, efficacy will also be analyzed using the 'sliding dichotomy'. A subgroup analysis will be carried out by stratifying the patients as they present more or less than 10mL of pericontusional edema in the preinclusion CT. We will perform an interim analysis with the patients included during the first year to calculate the conditional power. An independent statistician will blindly perform this analysis. At the same time a safety analysis will be also perfomed. A study with 600 patients would have about 80% power (two sided alpha=5%) to detect a 12% absolute increased (from 50% to 62%) in good outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: Dexamethasone OralDexamethasone will be a short and descending course: 4mg/6 hours (2 days); 4 mg/8 hours (2 days); 2 mg/6 hours (2 days); 2 mg/8 hours (2 days); 1 mg/8 hours (2 days); 1 mg/12 hours (2 days). Dexamethasone (Fortecortin®) will be acquired from ERN, SA. Laboratories (Barcelona, Spain). The Son Espases Pharmacy Department will be in charge of developing and conditioning the 4mg, 2mg and 1mg dexamethasone / placebo capsules needed for 12 days of treatment, keeping the researchers blind |
| Control | Placebo comparator | Drug: Placebo oral tabletThe preparation and conditioning of the capsules will be carried out following the standardized work procedures of the pharmaceutical laboratory and its quality controls, previously authorized by the Agencia Española del Medicamento (AEMPS). The Son Espases Pharmacy Department will be responsible for identifying the containers and sending them by courier to the participating hospitals. A record of the dispensing of test samples will be kept and will be sent in acknowledgment of receipt for control |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- -Patients who have suffered a head injury and have one or more cerebral contusions with visible pericontusional edema in the CT scan.
- Patients with brain contusions in whom non-sugical treatment has been selected initially.
- Age 18 or over and under 85
- Signing of informed consent by the patient or by his legal representative. The fundamental eligibility criterion is the responsible clinician's 'uncertainty' as to whether or not to use dexamethasone in a particular patient with TBI. This pragmatic approach will allow us to see whether the intervention improves patient outcomes under real-life conditions.
Key exclusion criteria (14 listed)
- Patients with TBI and brain contusions who have required surgery to evacuate the cerebral contusion before randomization.
- Patients with TBI who have required a craniotomy before randomization for any other reason: evacuation of subdural, epidural hematoma or depressed skull fracture.
- Patients with an extracranial Injury Severity Score greater than 18 points.
- Patients in whom the use of corticosteroids is contraindicated.
- Patients who take oral corticosteroids chronically.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexamethasone OralIt will be a short and descending course of oral dexamethasone: 4mg/6 hours (2 days); 4 mg/8 hours (2 days); 2 mg/6 hours (2 days); 2 mg/8 hours (2 days); 1 mg/8 hours (2 days); 1 mg/12 hours (2 days). | Drug | Dexamethasone |
| Placebo oral tabletThe preparation and conditioning of the placebo capsules will be carried out following the standardized work procedures of the pharmaceutical laboratory and its quality controls, previously authorized by the Agencia Española del Medicamento (AEMPS). | Drug | Control |
Primary outcome
Glasgow Scale Outcome Extended (GOSE).
Time frame: one month
5 secondary outcomes
Number of episodes of neurological deterioration in both groups of patients during the 12 days of treatment.
Time frame: 14 days
Symptoms associated with TBI in both groups of patients during the 12 days of treatment.
Time frame: 14 days
Volume of pericontusional edema before and after 12 days of treatment in both groups of patients.
Time frame: 14 days
Presence of adverse events between the two groups during the 12 days of treatment.
Time frame: 14 days
Neuropsychological tests between the two groups of patients one month and 6 months after the TBI.
Time frame: one month
Results and safety
The study was stopped early (reason given: The study was stopped because of lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2026.
- Background: PubMed 33120830Moll A, Lara M, Pomar J, Orozco M, Frontera G, Llompart-Pou JA, Moratinos L, Gonzalez V, Ibanez J, Perez-Barcena J. Effects of dexamethasone in traumatic brain injury patients with pericontusional vasogenic edema: A prospective-observational DTI-MRI study. Medicine (Baltimore). 2020 Oct 23;99(43):e22879. doi: 10.1097/MD.0000000000022879.
- Background: PubMed 32709492Lara M, Moll A, Mas A, Picado MJ, Gassent C, Pomar J, Llompart-Pou JA, Brell M, Ibanez J, Perez-Barcena J. Use of diffusion tensor imaging to assess the vasogenic edema in traumatic pericontusional tissue. Neurocirugia (Engl Ed). 2020 Jul 21:S1130-1473(20)30080-4. doi: 10.1016/j.neucir.2020.05.002. Online ahead of print. English, Spanish.
- Results publication: PubMed 33546038Perez-Barcena J, Castano-Leon AM, Lagares Gomez-Abascal A, Barea-Mendoza JA, Navarro Main B, Pomar Pons J, Perianez Parraga LDM, Ibanez Dominguez J, Chico-Fernandez M, Llompart-Pou JA, Frontera Juan G; DEXCON TBI trial collaborators. Dexamethasone for the treatment of traumatic brain injured patients with brain contusions and pericontusional edema: Study protocol for a prospective, randomized and double blind trial. Medicine (Baltimore). 2021 Jan 22;100(3):e24206. doi: 10.1097/MD.0000000000024206.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone Oral in people with Traumatic Brain Injury and Cerebral Edema, run by Jon Pérez Bárcena at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: The study was stopped because of lack of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glasgow Scale Outcome Extended (GOSE). (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04303065, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2026.