Hypertonic Resuscitation Following Severe Traumatic Brain Injury (TBI)
Public ClinicalTrials.gov record NCT00316004. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Phase 3 Study of Hypertonic Resuscitation Following Severe Traumatic Brain Injury (TBI)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT00316004
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 1,331 participants
Conditions and interventions
Conditions
Interventions
- 7.5% Hypertonic Saline in 6% Dextran-70 (HSD) Drug
- 7.5% Hypertonic Saline (HS) Drug
- 0.9% Normal Saline (NS) Drug
Drug
Eligibility (public fields only)
- Age range
- 15 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 2006 (Type not available)
- Primary completion
- May 2009 (Actual)
- Completion
- Jan 2010 (Actual)
- Last update posted
- May 19, 2011
2006 – 2010
United States locations
- U.S. sites
- 10
- U.S. states
- 9
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Resuscitation Center, University of Alabama | Birmingham | Alabama | 35249 | — |
| Orange County/UC Irvine | Orange | California | 92868 | — |
| UCSD-San Diego Resuscitation Research Center | San Diego | California | 92103 | — |
| Iowa Resuscitation Network, University of Iowa Carver College of Medicine | Iowa City | Iowa | 52242 | — |
| Portland Resuscitation Outcomes Consortium, Oregon Health & Sciences University | Portland | Oregon | 97239 | — |
| The Pittsburgh Resuscitation Network, University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | — |
| The Regional Medical Center at Memphis | Memphis | Tennessee | 38103 | — |
| Dallas Center for Resuscitation Research, University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| Seattle-King County Center for Resuscitation Research, University of Washington | Seattle | Washington | 98195 | — |
| Milwaukee Resuscitation Network, Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00316004, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 19, 2011 · Synced Oct 27, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00316004 live on ClinicalTrials.gov.