NCT01215019

Brief Summary

Osmotic therapy is a mainstay in the treatment of intracranial hypertension after traumatic brain injury.This study proposes to compare two hypertonic saline agents in patients with traumatic brain injury.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2010

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
Last Updated

April 4, 2013

Status Verified

April 1, 2013

Enrollment Period

10 years

First QC Date

October 4, 2010

Last Update Submit

April 1, 2013

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injury

Outcome Measures

Primary Outcomes (1)

  • Assess efficacy of 20% mannitol versus 3% MaCl in controlling elevated intracranial pressure in acute traumatic brain injury

    Two years

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

20% Mannitol

Drug: Mannitol

Arm 2

ACTIVE COMPARATOR

3% sodium chloride

Drug: NaCl

Interventions

MannitolDRUG

20% Mannitol, 1-5 doses as needed to control ICP

Arm 1
NaClDRUG

3% sodium chloride injection, 1-5 doses, as needed to control ICP

Also known as: 3% sodium chloride injection
Arm 2

Eligibility Criteria

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

You may qualify if:

  • All hemodynamically stable patients aged 18-65 presenting with acute traumatic brain injury requiring monitoring of intracranial pressure (ICP) will be screened for randomization.

You may not qualify if:

  • Patients with known pre-existing renal abnormalities or serum creatinine greater than or equal to 2.0mg/dl will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wishard Memorial Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

MannitolSodium Chloride

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydratesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Richard B. Rodgers, MD

    Indiana University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2010

First Posted

October 5, 2010

Study Start

October 1, 2010

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

April 4, 2013

Record last verified: 2013-04

Locations

US(1)