Know Cancer

forgot password

A Randomized, Open Label Clinical Trial of Sustained Hypernatremia for the Prevention and Treatment of Cerebral Edema in Traumatic Brain Injury

Phase 1/Phase 2
18 Years
60 Years
Not Enrolling
Traumatic Brain Injury, Subdural Hematoma, Cerebral Contusion, Head Injury, Cerebral Edema

Thank you

Trial Information

A Randomized, Open Label Clinical Trial of Sustained Hypernatremia for the Prevention and Treatment of Cerebral Edema in Traumatic Brain Injury

Inclusion Criteria:

- Adults (18 - 60 years old)

- Severe traumatic brain injury with intracranial pressure monitoring

- Initial GCS 5-8 (obtained free of the effects of neuromuscular blockade or sedatives)

- Clearly defined time of injury no more than 8 hours before administration of study

- Written consent obtained from legally authorized representative (LAR)

- Severe swelling prone injury patterns:

1. Contusion - frontal or temporal (> 20 cc)

2. Acute convexity subdural hematoma with any evidence of midline shift

Exclusion Criteria:

- Patients undergoing emergent (within 15 minutes) or urgent neurosurgery (within 4
hours) following emergency department arrival (bedside procedures, such as
intracranial pressure monitor placement are excluded)

- Posterior fossa lesions

- Penetrating brain injury

- Spinal column instability and/or spinal cord injury with neurological deficit

- Pregnant

- Concomitant severe nonsurvivable injury

- Acute renal failure ; Chronic renal failure (serum creatinine of > 2.5 mg/dL, history
of ongoing dialysis, glomerular filtration rate <30mL/min/1.73 m2); Severe pulmonary
edema; Severe heart failure; Severe liver failure (AST, ALT, or bilirubin > 2 times

- Known use of warfarin, clopidogrel, prasugrel, cilostazol, heparin, low molecular
weight heparin, heparinoids, abciximab or similar antiplatelet agents

- Treatment with another investigational drug within the prior 30 days

- Systolic blood pressure < 90 mm HG not responsive to fluid resuscitation

- INR > 1.4

- Hospitalization for brain injury or neurological disease within previous 3 years

- Admission serum sodium < 135 mmol/L

- > 8 hours from the time of injury to admission

- Fix/dilated pupil suspected to be secondary to brainstem compression

- Duret (brainstem) hemorrhage indicating brainstem herniation

- PaO2 < 60 mmHg on admission (when blood gases are drawn as standard of care)

- Prisoner or other persons unable to make a true, voluntary and uncoerced decision
whether or not to participate in the study

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Primary Efficacy Objective

Outcome Description:

The primary efficacy objective of this study is to assess whether patients with severe TBI treated with sustained hypernatremia will show a decrease in neuroimaging defined edema compared to patients treated as the current standard of care.

Outcome Time Frame:

72 hours ; 120 hours ; 30 days

Safety Issue:


Principal Investigator

Brian P Walcott, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Massachusetts General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

July 2012

Completion Date:

August 2013

Related Keywords:

  • Traumatic Brain Injury
  • Subdural Hematoma
  • Cerebral Contusion
  • Head Injury
  • Cerebral Edema
  • Brain Injuries
  • Hematoma, subdural
  • Decompressive Craniectomy
  • Saline solution, hypertonic
  • Hypernatremia
  • Intracranial hemorrhages
  • Head Injuries, closed
  • Intracranial pressure
  • Brain edema
  • Critical care
  • Brain Diseases
  • Central Nervous System Diseases
  • Nervous System Diseases
  • Wounds and Injuries
  • Physiological Effects of Drugs
  • Pharmacologic Actions
  • Brain Edema
  • Contusions
  • Edema
  • Craniocerebral Trauma
  • Hematoma
  • Hematoma, Subdural
  • Hypernatremia
  • Brain Injuries