Trial · NCT01411852
Field Trial of Hypotensive Versus Standard Resuscitation for Hemorrhagic Shock After Trauma
NCT01411852, Phase 2, Completed, University of Washington; results first posted 2014-10-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Field Trial of Hypotensive Versus Standard Resuscitation for Hemorrhagic Shock After Trauma. Trials, record NCT01411852. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01411852
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Field Trial of Hypotensive Versus Standard Resuscitation for Hemorrhagic Shock After Trauma
- NCT number
- NCT01411852
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 192 participants, actual
- Lead sponsor
- University of Washington
- Conditions
- Blunt Trauma, Penetrating Wound, Hemorrhagic Shock
- Interventions
- 0.9% Sodium Chloride 250 mL bolus, 0.9% Sodium Chloride 2000 mL bolus
- First posted
- 2011-08-08
- Last updated
- 2015-01-13
- Results first posted
- 2014-10-20
- Limitations and caveats
One patient was determined to have been in police custody at the time of enrollment, which was a protocol violation. This patient was randomized to the controlled resuscitation group but was not included in the primary or secondary outcome analyses.
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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 |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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 | Patients with traumatic shock due to blunt or penetrating mechanisms | liters | MEAN |
| PRIMARY | 24 Hour Mortality | From time of hospital arrival through the first 24 hours | All patients except for one who was enrolled while in police custody | participants | NUMBER |
| 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 | All patients enrolled in the study. | participants | NUMBER |
| SECONDARY | Total Fluid Requirement During First 24 Hours | From ED arrival through the first 24 hours | All patients except one who was enrolled while in police custody | Liters | MEAN |
| SECONDARY | Total Blood Product Requirements in First 24 Hours | From ED arrival through the first 24 hours | All patients except one who was enrolled while in police custody | Liters | MEAN |
| SECONDARY | Base Deficit on Admission to the Emergency Department (ED) | From final Emergency Department arrival time through first 24 hours | Patient with the first base deficit recorded in the first 24 hours of the ED arrival | mmol/Liter | MEAN |
| SECONDARY | Hemoglobin on Admission to the Emergency Department | From final Emergency Department arrival time through first 24 hours | All patients with a first hemoglobin measured within the first 24 hours of ED arrival | grams/deciliter | MEAN |
| SECONDARY | Platelet Value on Admission | From final Emergency Department arrival time through first 24 hours | All patients with the first platelet value measured within the first 24 hours of ED arrival | 10^9 Platelets/Liters | MEAN |
| SECONDARY | International Normalized Ratio (INR) on Admission to the Emergency Department | From final Emergency Department arrival time through first 24 hours | Patients who had a first INR value measured within the first 24 hours of ED arrival | ratio | MEAN |
| SECONDARY | Hemorrhage Control Procedure Within 2 Hours of ED Arrival | From ED arrival through the first 2 hours | All patients except for 1 patient who was enrolled while in police custody | participants | NUMBER |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group45
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Total Volume of All Crystalloid Given for Early Resuscitation (Feasibility) | Standard Resuscitation (SR) | 2.04 | 95% Confidence Interval 1.76 to 2.32 | liters | |
| Total Volume of All Crystalloid Given for Early Resuscitation (Feasibility) | Controlled Resuscitation (CR) | 1.04 | 95% Confidence Interval 0.75 to 1.34 | liters | |
| Total Volume of All Crystalloid Given for Early Resuscitation (Feasibility) | ECV Difference [Standard - Controlled] | 1 | 95% Confidence Interval 0.6 to 1.4 | liters | |
| 24 Hour Mortality | Standard Resuscitation (SR) | Died within first 24 hours after hospital arrival | 14 | participants | |
| 24 Hour Mortality | Controlled Resuscitation (CR) | Died within first 24 hours after hospital arrival | 5 | participants | |
| 24 Hour Mortality | Standard Resuscitation (SR) | Alive at 24 hours after hospital arrival | 81 | participants | |
| 24 Hour Mortality | Controlled Resuscitation (CR) | Alive at 24 hours after hospital arrival | 91 | participants | |
| Number of Ineligible Patients Enrolled at the Time of Randomization | Standard Resuscitation (SR) | 24 | participants | ||
| Number of Ineligible Patients Enrolled at the Time of Randomization | Controlled Resuscitation (CR) | 9 | participants | ||
| Total Fluid Requirement During First 24 Hours | Standard Resuscitation (SR) | 4.43 | Standard Deviation 4.02 | Liters |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Prehospital Intervention Phase | STARTED | 0.9% Sodium Chloride 2000 mL Bolus | 95 | |
| Prehospital Intervention Phase | STARTED | 0.9% Sodium Chloride 250 mL Bolus | 96 | |
| Prehospital Intervention Phase | COMPLETED | 0.9% Sodium Chloride 2000 mL Bolus | 83 | |
| Prehospital Intervention Phase | COMPLETED | 0.9% Sodium Chloride 250 mL Bolus | 89 | |
| Prehospital Intervention Phase | NOT COMPLETED | 0.9% Sodium Chloride 2000 mL Bolus | 12 | |
| Prehospital Intervention Phase | NOT COMPLETED | 0.9% Sodium Chloride 250 mL Bolus | 7 | |
| Hospital Intervention Phase | STARTED | 0.9% Sodium Chloride 2000 mL Bolus | 83 | |
| Hospital Intervention Phase | STARTED | 0.9% Sodium Chloride 250 mL Bolus | 89 | |
| Hospital Intervention Phase | COMPLETED | 0.9% Sodium Chloride 2000 mL Bolus | 59 | |
| Hospital Intervention Phase | COMPLETED | 0.9% Sodium Chloride 250 mL Bolus | 71 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events22
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Pneumonia | Infections and infestations | Standard Resuscitation (SR) | 2 | 95 | 2 |
| serious | Pneumonia | Infections and infestations | Controlled Resuscitation (CR) | 6 | 96 | 6 |
| serious | Urinary tract infection | Infections and infestations | Standard Resuscitation (SR) | 3 | 95 | 3 |
| serious | Urinary tract infection | Infections and infestations | Controlled Resuscitation (CR) | 3 | 96 | 3 |
| serious | Wound infection | Infections and infestations | Standard Resuscitation (SR) | 0 | 95 | 0 |
| serious | Wound infection | Infections and infestations | Controlled Resuscitation (CR) | 5 | 96 | 5 |
| serious | Sepsis | Infections and infestations | Standard Resuscitation (SR) | 1 | 95 | 1 |
| serious | Sepsis | Infections and infestations | Controlled Resuscitation (CR) | 1 | 96 | 1 |
| serious | Bloodstream infection | Infections and infestations | Standard Resuscitation (SR) | 0 | 95 | 0 |
| serious | Bloodstream infection | Infections and infestations | Controlled Resuscitation (CR) | 1 | 96 | 1 |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Standard Resuscitation (SR) | ||
| Total, all-cause mortality | Controlled Resuscitation (CR) | ||
| Total, other adverse events | Standard Resuscitation (SR) | 0 | 95 |
| Total, other adverse events | Controlled Resuscitation (CR) | 0 | 96 |
| Total, serious adverse events | Standard Resuscitation (SR) | 8 | 95 |
| Total, serious adverse events | Controlled Resuscitation (CR) | 18 | 96 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U01HL077863 | Resuscitation Outcomes Consortium (ROC) Data Coordinating Center | MAY, SUSANNE | UNIVERSITY OF WASHINGTON | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2004 to 2015 |
Source NIH RePORTER
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Standard Resuscitation (SR) vs Controlled Resuscitation (CR): In-hospital Mortality | Trial comparisons |
| Standard Resuscitation (SR) vs Controlled Resuscitation (CR): Hemorrhage Control Procedure Within 2 Hours of ED Arrival | Trial comparisons |
| Standard Resuscitation (SR) vs Controlled Resuscitation (CR): Acute Renal Failure Classification Score of Risk Without Glomerular Filtration Rate (GFR) | Trial comparisons |
| Standard Resuscitation (SR) vs Controlled Resuscitation (CR): Acute Renal Failure Classification Score of Injury Without Glomerular Filtration Rate (GFR) | Trial comparisons |
| Standard Resuscitation (SR) vs Controlled Resuscitation (CR): Number of Ineligible Patients Enrolled at the Time of Randomization | Trial comparisons |
| Standard Resuscitation (SR) vs Controlled Resuscitation (CR): Acute Renal Failure Classification Score of Failure Without Glomerular Filtration Rate (GFR) | Trial comparisons |
| Standard Resuscitation (SR) vs Controlled Resuscitation (CR): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01411852
GET https://conductscience.org/api/trials/v1/NCT01411852/results?page=2