| Primary | Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Completer Analysis | 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 completed at 6 months after injury. | The primary analysis was designed as modified intent-to-treat, with all patients who had fluid connected to intravenous (IV) tubing included regardless of how much fluid was administered. Per the a priori trial design, patients for whom the fluid bag was opened but not connected to the IV were not considered enrolled in the trial. | Posted | | Number | | Participants | | 6 months after injury | | | | ID | Title | Description |
|---|
| OG000 | 7.5% Hypertonic Saline/6% Dextran (HSD) | 250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. | | OG001 | 7.5% Hypertonic Saline (HS) | 250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. | | OG002 | 0.9% Normal Saline (NS) | 250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. |
| | | Title | Denominators | Categories |
|---|
| | |
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| The null hypothesis is that there are no differences in the percent prevalence of poor outcome between the three groups. | test for differences in proportions | | 0.55 | The p-value was not adjusted for multiple comparisons. Test compares proportions across all three treatment groups. | | | | | | 95 | | | | | | No | Superiority or Other | | |
|
| Secondary | Subgroup of Participants With Head Abbreviated Injury Scores (AIS) Greater Than or Equal to 4 (Head AIS≥4) Assessed to Have Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Imputed Analysis | The Abbreviated Injury Scale (AIS) ranks injuries on a scale of 1 to 6, with 1 being minor, 2 moderate, 3 serious, 4 severe, 5 critical and 6 an unsurvivable injury. A priori secondary analyses included the subgroup of participants in each intervention group with a head AIS≥4, which is a diagnostic indicator of severe to lethal head injury. Of this subset of participants with AIS≥4, a second subset of participants with a GOSE≤4 at the 6 month follow up was analyzed. GOSE≤4 represents Upper Severe Disability or worse outcomes. 15% of subjects required imputation analysis for 6-month GOSE. | To adjust for 15% of subjects with absent 6-month GOSE data, an analysis using 20 hot deck imputations for the 6-month GOSE was done using data from patients who were discharged alive based on 1-month post discharge GOSE data or discharge GOSE (if 1-month post discharge data were not available), length of hospital stay, and treatment group. | Posted | | Number | | Participants (with imputed values) | | 6 months after injury | | | | ID | Title | Description |
|---|
| OG000 | 7.5% Hypertonic Saline/6% Dextran (HSD) | 250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. | | OG001 | 7.5% Hypertonic Saline (HS) |
|
| Primary | Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Imputed Analysis | Glasgow outcome score extended (GOSE) contains 8 categories: 1. Dead, 2. Vegetative State, 3. Lower Severe Disability, 4. Upper Severe Disability, 5. Lower Moderate Disability, 6. Upper Moderate Disability, 7. Lower Good Recovery and 8. Upper Good Recovery. To adjust for 15% of subjects with absent 6-month GOSE data, an analysis using 20 hot deck imputations for the 6-month GOSE was done using data from patients who were discharged alive based on 1-month post discharge GOSE data or discharge GOSE (if 1-month post discharge data were not available), length of hospital stay, and treatment group. | To adjust for 15% of subjects with absent 6-month GOSE data, an analysis using 20 hot deck imputations for the 6-month GOSE was done using data from patients who were discharged alive based on 1-month post discharge GOSE data or discharge GOSE (if 1-month post discharge data were not available), length of hospital stay, and treatment group. | Posted | | Number | | Participants (with imputed values) | | 6 months after injury | | | | ID | Title | Description |
|---|
| OG000 | 7.5% Hypertonic Saline/6% Dextran (HSD) | 250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. | | OG001 | 7.5% Hypertonic Saline (HS) | 250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. |
|
| Secondary | Subgroup of Participants With Head Abbreviated Injury Scores (AIS) Greater Than or Equal to 2 (Head AIS≥2) Assessed to Have Glasgow Outcome Scale-Extended (GOSE)≤4 at 6 Months: Imputed Analysis | The Abbreviated Injury Scale (AIS) ranks injuries on a scale of 1 to 6, with 1 being minor, 2 moderate, 3 serious, 4 severe, 5 critical and 6 an unsurvivable injury. A priori secondary analyses included the subgroup of participants in each intervention group with a head AIS≥2, which is a diagnostic indicator of moderate to lethal head injury. Of this subset of participants with AIS≥2, a second subset of participants with a GOSE≤4 at the 6 month follow up was analyzed. GOSE≤4 represents Upper Severe Disability or worse outcomes. 15% of subjects required imputation analysis for 6-month GOSE. | To adjust for 15% of subjects with absent 6-month GOSE data, an analysis using 20 hot deck imputations for the 6-month GOSE was done using data from patients who were discharged alive based on 1-month post discharge GOSE data or discharge GOSE (if 1-month post discharge data were not available), length of hospital stay, and treatment group. | Posted | | Number | | Participants (with imputed values) | | 6 months after injury | | | | ID | Title | Description |
|---|
| OG000 | 7.5% Hypertonic Saline/6% Dextran (HSD) | 250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. | | OG001 | 7.5% Hypertonic Saline (HS) |
|
| Secondary | Disability Rating Score (DRS) Categories of Disability | The DRS is an additional measure of neurological outcome that categorizes the patient's level of disability on a scale of 0 to 29, with 0 indicating no disability to 29 indicating extreme vegetative state. To adjust for 15% of subjects with absent 6-month DRS data, an analysis using 20 hot deck imputations for the 6-month DRS was done using data from patients who were discharged alive based on 1-month post discharge DRS data or discharge DRS (if 1-month post discharge data were not available), length of hospital stay, and treatment group. | To adjust for 15% of subjects with absent 6-month DRS data, an analysis using 20 hot deck imputations for the 6-month DRS was done using data from patients who were discharged alive based on 1-month post discharge DRS data or discharge DRS (if 1-month post discharge data were not available), length of hospital stay, and treatment group. | Posted | | Number | | Participants (with imputed values) | | 6 months after injury | | | | ID | Title | Description |
|---|
| OG000 | 7.5% Hypertonic Saline/6% Dextran (HSD) | 250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. | | OG001 | 7.5% Hypertonic Saline (HS) | 250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. |
|
| Secondary | 28 Day Survival | The patient who is admitted to the hospital after injury and is alive on the 28th day after injury. For 28-day survival, patients with missing 28-day vital status who were known to be discharged alive prior to 28 days were assumed to be alive at day 28. | An analysis of this secondary outcome was done for all participants assigned to each of the three groups who did not refuse or were lost to follow-up prior to discharge. | Posted | | Number | | Participants | | 28 days after injury | | | | ID | Title | Description |
|---|
| OG000 | 7.5% Hypertonic Saline/6% Dextran (HSD) | 250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. | | OG001 | 7.5% Hypertonic Saline (HS) | 250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. | | OG002 | 0.9% Normal Saline (NS) | 250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. |
|
| Secondary | Survival at Hospital Discharge up to 6 Months From Date of Injury | The patient who is admitted to the hospital alive after injury and is alive when discharged from the hospital up to 6 months from the date of injury. | An analysis of this secondary outcome was done for all participants assigned to each of the three groups who had relevant data. | Posted | | Number | | Participants | | Date of hospital discharge up to 6 months from date of injury | | | | ID | Title | Description |
|---|
| OG000 | 7.5% Hypertonic Saline/6% Dextran (HSD) | 250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. | | OG001 | 7.5% Hypertonic Saline (HS) | 250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. | | OG002 | 0.9% Normal Saline (NS) | 250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. |
|
| Secondary | Acute Respiratory Distress Syndrome (ARDS)-Free Survival to Day 28 | The patient is alive and free of ARDS from the date of injury through to the 28th day following injury. The diagnosis of ARDS is based on standard criteria: a) hypoxia with a ratio of arterial oxygen pressure to percent oxygen delivered of less than 200; b) bilateral infiltrates on chest X-ray; and c) clinical evidence of increased left atrial pressure or pulmonary artery wedge pressure of greater than 18 mmHg. | Number of participants analyzed in each group is the actual number analyzed, which does not include participants with one of the following: 1. prehospital death; 2. transfer to another hospital without IRB approval; or 3. patient, family member, or legally authorized representative refused consent and was withdrawn from the study. | Posted | | Number | | Participants | | From day of injury to 28 days after injury | | | | ID | Title | Description |
|---|
| OG000 | 7.5% Hypertonic Saline/6% Dextran (HSD) | 250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. | | OG001 | 7.5% Hypertonic Saline (HS) | 250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. |
|
| Secondary | Worst Multiple Organ Dysfunction Score (MODS) Through Day 28 | Multiple Organ Dysfunction Score is described as: Six organ systems were chosen: 1) respiratory; 2) renal; 3) hepatic; 4) cardiovascular; 5) hematologic; and 6) neurologica. A score of 0-4 was allotted for each organ according to function (0 being normal function through 4 for most severe dysfunction) with a maximum score of 24. The worst score based on available data (missing values were assumed normal) was taken for calculation of the aggregate score. Deaths are assigned the worst score (24). | Number of participants analyzed in each group is the actual number analyzed, which does not include participants with one of the following: 1. prehospital death; 2. transfer to another hospital without IRB approval; or 3. patient, family member, or legally authorized representative refused consent and was withdrawn from the study. | Posted | | Mean | Standard Deviation | Scores on a scale | | From day of injury to 28 days after injury | | | | ID | Title | Description |
|---|
| OG000 | 7.5% Hypertonic Saline/6% Dextran (HSD) | 250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. | | OG001 | 7.5% Hypertonic Saline (HS) | 250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. |
|
| Secondary | Ventilator-free Days Through Day 28 | The number of days beginning with the day of 911 call counted as "Day 0" through day 28 that the patient did not require mechanical ventilation. Deaths are assigned the worst score (0). | Number of participants analyzed in each group is the actual number analyzed, which does not include participants with one of the following: 1. prehospital death; 2. transfer to another hospital without IRB approval; or 3. patient, family member, or legally authorized representative refused consent and was withdrawn from the study. | Posted | | Mean | Standard Deviation | Days | | From day of injury to 28 days after injury | | | | ID | Title | Description |
|---|
| OG000 | 7.5% Hypertonic Saline/6% Dextran (HSD) | 250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. | | OG001 | 7.5% Hypertonic Saline (HS) | 250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. | | OG002 | 0.9% Normal Saline (NS) | 250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. |
|
| Secondary | Days Alive Out of the Intensive Care Unit (ICU) Through Day 28 | The number of days the patient is alive and not being cared for in the intensive care unit | Number of participants analyzed in each group is the actual number analyzed, which does not include participants with one of the following: 1. prehospital death; 2. transfer to another hospital without IRB approval; or 3. patient, family member, or legally authorized representative refused consent and was withdrawn from the study. | Posted | | Mean | Standard Deviation | Days | | From day of injury to 28 days after injury | | | | ID | Title | Description |
|---|
| OG000 | 7.5% Hypertonic Saline/6% Dextran (HSD) | 250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. | | OG001 | 7.5% Hypertonic Saline (HS) | 250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. | | OG002 | 0.9% Normal Saline (NS) | 250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. |
|
| Secondary | Days Alive Out of the Hospital Through Day 28 | The number of days the patient is alive and no longer an inpatient in the hospital through day 28 | Number of participants analyzed in each group is the actual number analyzed, which does not include participants with one of the following: 1. prehospital death; 2. transfer to another hospital without IRB approval; or 3. patient, family member, or legally authorized representative refused consent and was withdrawn from the study. | Posted | | Mean | Standard Deviation | Days | | From day of injury to 28 days after injury | | | | ID | Title | Description |
|---|
| OG000 | 7.5% Hypertonic Saline/6% Dextran (HSD) | 250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. | | OG001 | 7.5% Hypertonic Saline (HS) | 250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. | | OG002 | 0.9% Normal Saline (NS) | 250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. |
|
| Secondary | Presence of Nosocomial Infections | Includes one or more nosocomial infections diagnosed during the hospital stay but not present on admission to the hospital from the following list: pneumonia, bloodstream infection, urinary tract infection, and/or wound infection | An analysis of this secondary outcome was done for all participants assigned to each of the three groups who had relevant data. Percentages were based on population at risk. Row 1 nosocomial infections; Row 2 pneumonia; Row 3 bloodstream infections; Row 4 urinary tract infections; and Row 5 wound infections | Posted | | Number | | Diagnoses | | From day of injury to 28 days after injury | | | | ID | Title | Description |
|---|
| OG000 | 7.5% Hypertonic Saline/6% Dextran (HSD) | 250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. | | OG001 | 7.5% Hypertonic Saline (HS) | 250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. | | OG002 | 0.9% Normal Saline (NS) | |
|
| Secondary | Total Fluids in First 24 Hours | The average (mean) total amount of intravenous (IV) fluids given in the pre-hospital setting and the hospital setting in the first 24 hours following the time of the 911 call | An analysis of this secondary outcome was done for all participants assigned to each of the three groups who had relevant data. | Posted | | Mean | Standard Deviation | Liters | | First 24 hours from the time dispatch received 911 call | | | | ID | Title | Description |
|---|
| OG000 | 7.5% Hypertonic Saline/6% Dextran (HSD) | 250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. | | OG001 | 7.5% Hypertonic Saline (HS) | 250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. | | OG002 | 0.9% Normal Saline (NS) | 250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. |
|
| Secondary | Packed Red Blood Cells (PRBC) First 24 Hours | The average (mean) number of units of packed red blood cells (PRBC) transfused in the first 24 hours following the time of the 911 call in each group. | An analysis of this secondary outcome was done for all participants assigned to each of the three groups who had relevant data. | Posted | | Mean | Standard Deviation | Unit of PRBC | | First 24 hours from the time dispatch received 911 call | | | | ID | Title | Description |
|---|
| OG000 | 7.5% Hypertonic Saline/6% Dextran (HSD) | 250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. | | OG001 | 7.5% Hypertonic Saline (HS) | 250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. | | OG002 | 0.9% Normal Saline (NS) | 250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. |
|
| Secondary | Discharge Disposition | Disposition of patient at the time of discharge from the acute care hospital | Number of participants analyzed in each group is the actual number analyzed, which does not include participants with one of the following: 1. prehospital death; 2. transfer to another hospital without IRB approval; or 3. patient, family member, or legally authorized representative refused consent and was withdrawn from the study. | Posted | | Number | | Participants | | Duration of hospital stay | | | | ID | Title | Description |
|---|
| OG000 | 7.5% Hypertonic Saline/6% Dextran (HSD) | 250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. | | OG001 | 7.5% Hypertonic Saline (HS) | 250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. | | OG002 | 0.9% Normal Saline (NS) | 250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting. |
|