Trial · NCT00878631
Feasibility Trial of Traumatic Brain Injured Patients Randomized in the Prehospital Setting to Either Hypertonic Saline and Dextran Versus Normal Saline
NCT00878631, Phase 2, Phase 3, Completed, Unity Health Toronto
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Feasibility Trial of Traumatic Brain Injured Patients Randomized in the Prehospital Setting to Either Hypertonic Saline and Dextran Versus Normal Saline. Trials, record NCT00878631. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00878631
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Feasibility Trial of Traumatic Brain Injured Patients Randomized in the Prehospital Setting to Either Hypertonic Saline and Dextran Versus Normal Saline
- NCT number
- NCT00878631
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 113 participants, actual
- Lead sponsor
- Unity Health Toronto
- Conditions
- Brain Injuries
- Interventions
- hypertonic saline mixed with dextran, Normal Saline
- First posted
- 2009-04-09
- Last updated
- 2009-04-09
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | baseline survival rates for the treatment and control group to aid in the design of a definitive multicentre trial | survival at 48 hours, hospital discharge, 30 days and 4 months | |
| Primary | randomization compliance rate | duration of enrolment | |
| Primary | ease of protocol implementation in the out-of-hospital setting | duration of study | |
| Primary | adverse event rate of hypertonic saline dextran infusion | duration of study | |
| Secondary | neurocognitive outcomes at discharge (cerebral performance category) and at 4 months (functional independence measure, disability rating scale, Glasgow Outcome Scale and Glasgow outcome Scale Extended | discharge and at 4 months post incident | |
| Secondary | neuropsychological outcomes including learning and memory, working memory, executive function, language function, visuospatial function, speed of processing and Beck Depression Scale. A focused attention reaction time test was added to 12 month testing. | at 4 and 12 months post incident | |
| Secondary | magnetic resonance imaging to evaluate effects of HSD on brain atrophy post-injury | 4 months post incident | |
| Secondary | the effect of HSD in modulating the immuno-inflammatory response to severe head injury and its effect on modulation the release of neuro-biomarkers into serum; evaluating the role of serum neuro-biomarkers in predicting patient outcome | samples taken within 48 hours of incident |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00878631
GET https://conductscience.org/api/trials/v1/NCT00878631/registered