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NCT00316004 · ClinicalTrials.gov registry record · Phase 3
Hypertonic Resuscitation Following Severe Traumatic Brain Injury (TBI)
A Phase 3 study, sponsored by University of Washington.
- Terminated
- Registry status
- Phase 3
- Development phase
- 1,331
- Enrollment target
NCT00316004: Clinical Trial Phase 3 study, sponsored by University of Washington.
NCT00316004 is a Phase 3 study that was terminated before completion, run by University of Washington. The registered enrollment target is 1,331 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00316004, a Phase 3 study, was terminated before completion, sponsored by University of Washington.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 1,331 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if hypertonic saline with and without dextran can improve neurologic outcomes in victims of severe traumatic brain injury (TBI). Injury and lost blood from trauma can cause your body to go into shock (low blood pressure related to blood loss). This decreased blood flow can lead to organ damage. In order to restore the blood pressure and blood flow, the medics give fluids into the patients' veins as soon as possible. This is called "resuscitation". The fluid most commonly used is "isotonic" or one that is the same salt concentration as the blood. The investigators are trying to determine if infusing a "hypertonic" fluid or one more concentrated than the blood can increase the blood pressure and restore blood flow more efficiently. The hypertonic fluids they are using are called hypertonic saline with dextran (HSD) and hypertonic saline (no dextran). Hypertonic saline is a salt solution that is slightly more concentrated than blood. Dextran is a sugar solution.
Primary Outcome
Glasgow outcome score extended (GOSE) contains eight categories: 1. Dead, 2. Vegetative State (VS), 3. Lower Severe Disability (Lower SD), 4. Upper Severe Disability (Upper SD), 5. Lower Moderate Disability (Lower MD), 6. Upper Moderate Disability (Upper MD), 7. Lower Good Recovery (Lower GR) and 8. Upper Good Recovery (Upper GR). A measured neurological outcome of GOSE≤4 is a poor outcome of severe disability, vegetative state, or death. Completer analysis includes only those patients with GOSE
Interventions
- DRUG 0.9% Normal Saline (NS)
- DRUG 7.5% Hypertonic Saline in 6% Dextran-70 (HSD)
- DRUG 7.5% Hypertonic Saline (HS)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,331 participants |
| Start Date | 2006-05 |
| Est. Completion | 2010-01 |
| Phase | Phase 3 |
Why NCT00316004 stopped before completion
NCT00316004 is an interventional study that assigns participants to a tested intervention. Its 1,331 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (72% higher).
The record links to 0 conditions, and to 3 interventions - of which 0.9% Normal Saline (NS) is the first listed.
NCT00316004 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00316004 about?
NCT00316004 is a clinical study titled "Hypertonic Resuscitation Following Severe Traumatic Brain Injury (TBI)". The purpose of this study is to determine if hypertonic saline with and without dextran can improve neurologic outcomes in victims of severe traumatic brain injury (TBI). Injury and lost blood from trauma can cause your body to go into shock (low blood pressure related to blood loss). This decrease...
What is the current status of trial NCT00316004?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 1,331 participants. The study started on 2006-05. Estimated completion is 2010-01.
What interventions are being tested in trial NCT00316004?
The interventions under investigation include: 0.9% Normal Saline (NS) (DRUG), 7.5% Hypertonic Saline in 6% Dextran-70 (HSD) (DRUG), 7.5% Hypertonic Saline (HS) (DRUG).
Who is sponsoring clinical trial NCT00316004?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00316004's enrollment target sits among peer trials
1,331 183rd of 2000 higher than 1,818 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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