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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 is a Phase 3 study that was terminated before completion, run by University of Washington. The registered enrollment target is 1,331 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00316004
The ClinicalTrials.gov registry entry for NCT00316004 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 1,331 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which 0.9% Normal Saline (NS) is the first listed.
NCT00316004 reports 0 study locations.
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.
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