Hypertension Trial, Recruiting NCT05889650 Sponsor: Brain Trauma Foundation Condition: Hypertension
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Hypertension Trial, Recruiting

NCT05889650
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 to 65 years old
  • People with a low level of consciousness, as measured by a standard brain injury scale (Glasgow Coma Scale score of 3 to 8)
  • People whose pupils are equal in size and both react to light
  • People whose brain CT scan (on arrival or after surgery) shows the brain has shifted no more than 5mm from its normal central position
  • People whose brain CT scan shows certain fluid-filled spaces at the base of the brain (called quadrigeminal cisterns) are at least partially open
  • People where the first treatment step can be started within 24 hours of the brain injury occurring
  • People who meet a specific safety score threshold (called the ELD safety score of 5 or higher) used to assess suitability for the procedure

Who may not be able to join:

  • People with a Glasgow Coma Scale score higher than 8 (a less severe level of reduced consciousness)
  • People whose brain CT scan shows those fluid-filled spaces at the base of the brain are completely closed off
  • People whose brain CT scan shows the brain has shifted more than 5mm from its central position
  • People with a Glasgow Coma Scale score of 3 whose pupils are both fixed and dilated (not reacting to light)
  • People whose brain CT scan shows signs of severe brain herniation (where parts of the brain are being pushed out of their normal position)
  • People with bruising in a specific area of the brain (temporal lobe) where nearby fluid spaces are also closed off on the same side
  • People who have suffered a penetrating brain injury (such as a gunshot or stab wound to the head)
  • People who have already undergone a surgical procedure to remove part of the skull
  • People who are pregnant
  • People who are currently incarcerated
  • People who, before their injury, already lacked the ability to make their own medical decisions, or who had previously documented wishes to avoid aggressive medical treatment
  • People with existing health conditions that already significantly affect their ability to function day-to-day, or whose life expectancy is less than one year
  • People for whom the trial procedure cannot safely be performed due to blood clotting problems, use of blood-thinning medications, a very low platelet count (below 50,000), or severe spine deformity
  • People with bleeding in the lower back portion of the brain (posterior fossa hemorrhage)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Halinder S Mangat, MD MSc, Brain Trauma Foundation; Kansas University Medical Center Research Institute

Phone: 240-6536638

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Brain Trauma Foundation
Registry
ClinicalTrials.gov
Start date
24 June 2024
Est. completion
15 June 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Safety of ELD in selected Severe TBI patients; Feasibility of ELD in selected Severe TBI patients

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov