Trial · NCT01411852
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Volume of All Crystalloid Given for Early Resuscitation (Feasibility) | From time of first intravenous or intraosseous insertion through the first 2 hours after hospital arrival or hemorrhage control, which ever occurs first | The primary feasibility endpoint was early crystalloid volume (ECV) defined as crystalloid infused from Emergency Medical Services (EMS) arrival at the scene until the end of the study period |
| Primary | 24 Hour Mortality | From time of hospital arrival through the first 24 hours | The 24 hour mortality endpoint for the total number of patients each arm |
| Secondary | Number of Ineligible Patients Enrolled at the Time of Randomization | From the time the paramedic with study drug kit arrived at patient's side to the time kit was opened prior to ED arrival | Eligibility criteria: Inclusion Criteria Included will be those with: 1. Blunt or penetrating injury 2. Age ≥15yrs or weight ≥50kg if age is unknown 3. Prehospital SBP ≤ 90 mmHg 5.3 Exclusion Criteria Excluded will be those with: 1. Ground level falls 2. Evidence of severe blunt or penetrating head injury with a Glasgow Coma Score (GCS) ≤ 8 3. Bilateral paralysis secondary to suspected spinal cord injury 4. Fluid greater than 250 ml was given prior to randomization 5. Cardiopulmonary resuscitation (CPR) by Emergency Medical Services (EMS) prior to randomization 6. Known prisoners 7. Known or suspected pregnancy 8. Drowning or asphyxia due to hanging 9. Burns Total Body Surface Area (TBSA) \> 20% 10. Time of call received at dispatch to study intervention \> 4 hours |
| Secondary | Total Fluid Requirement During First 24 Hours | From ED arrival through the first 24 hours | Total volume of fluid administered during the first 24 hours inclusive of crystalloids, blood products, 3% saline, mannitol, and other colloids |
| Secondary | Total Blood Product Requirements in First 24 Hours | From ED arrival through the first 24 hours | Total amount of blood products required: packed red blood cells (PRBC), fresh frozen plasma (FFP), platelets (plts), cryoprecipitate (cryo) |
| Secondary | Base Deficit on Admission to the Emergency Department (ED) | From final Emergency Department arrival time through first 24 hours | The first base deficit value reported from arterial blood lab work drawn after arrival in the final Emergency Department. This measure reflects the acid-base balance in the arterial blood. A negative number indicates that the blood is more acid that normal. |
| Secondary | Hemoglobin on Admission to the Emergency Department | From final Emergency Department arrival time through first 24 hours | The first hemoglobin value reported from blood drawn in the final Emergency Department |
| Secondary | Platelet Value on Admission | From final Emergency Department arrival time through first 24 hours | First platelet value from blood drawn in the the first 24 hours after arrival |
| Secondary | International Normalized Ratio (INR) on Admission to the Emergency Department | From final Emergency Department arrival time through first 24 hours | The first International normalized ratio (INR) value reported from blood drawn within the first 24 hours from arrival |
| Secondary | Hemorrhage Control Procedure Within 2 Hours of ED Arrival | From ED arrival through the first 2 hours | Hemorrhage control procedures include blood vessel ligated or embolized, organ packed or removed, laparotomy or thoracotomy |
| Secondary | Acute Renal Failure Classification Score of "Risk" Without Glomerular Filtration Rate (GFR) | From ED arrival through Day 28 | Increased plasma creatinine \> 1.5 x reference measure (ED admission). Urine criteria is based on 6-hour periods for this level of the RIFLE and cannot be assessed since study data are collected for 24-hour periods. This row includes patients who met the "Injury" and "Failure" criteria as well. Only measured for patients with at least 2 days of ICU stay assessed. |
| Secondary | Acute Renal Failure Classification Score of "Injury" Without Glomerular Filtration Rate (GFR) | From ED arrival through Day 28 | Increased plasma creatinine \> 2 x reference measure (ED admission) or urine output \< 0.5 mL/kg/h x 24h. The RIFLE urine criterion for this level actually specifies a 12 hour period of assessment but study data are collected for 24-hr periods. This row includes patients who met the "Failure" criteria as well. Only measured for patients with at least 2 days of ICU stay assessed. |
| Secondary | Acute Renal Failure Classification Score of "Failure" Without Glomerular Filtration Rate (GFR) | From ED arrival through the first 24 hours | Increased plasma creatinine \> 3 x reference measure (ED admission) or acute plasma creatinine = 350 umol/L or acute rise = 44 umol/L or urine output \< 0.3 mL/k/h x 24h. Only measured for patients with at least 2 days of ICU stay assessed. |
| Secondary | Ventilator Free Days Through Day 28 | From day of the 911 call through Day 28 | The number of days beginning with the day of the 911 call counted as "Day 0" through Day 28 during which the patient did not require mechanical ventilation. Deaths are assigned the worst score (0). |
| Secondary | Days Alive Out of the Intensive Care Unit (ICU) Through Day 28 | From day of the 911 call through Day 28 | The number of days beginning with the day of the 911 call counted as "Day 0" through Day 28 during which the patient is alive and not being cared for in the intensive care unit |
| Secondary | Days Alive Out of the Hospital Through Day 28 | From day of the 911 call through Day 28 | The number of days beginning with the day of the 911 call counted as "Day 0" through Day 28 during which the patient is alive and not being cared for in the hospital |
| Secondary | Blunt Trauma 24 Hour Mortality | From time of hospital arrival through first 24 hours | The 24 hour mortality endpoint for the total number of patients injured by blunt mechanisms in each arm. |
| Secondary | Penetrating Trauma 24 Hour Mortality | From time of hospital arrival through first 24 hours | The 24 hour mortality endpoint for the total number of patients injured by penetrating mechanisms in each arm. |
| Secondary | In-hospital Mortality | From day of the 911 call through hospital discharge | Number of patients who died prior to discharge. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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 list from software.
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GET https://conductscience.org/api/trials/v1/NCT01411852/registered