Comparison · NCT01411852-ea0edebf
Standard Resuscitation (SR) vs Controlled Resuscitation (CR): Number of Ineligible Patients Enrolled at the Time of Randomization
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Standard Resuscitation (SR) vs Controlled Resuscitation (CR): Number of Ineligible Patients Enrolled at the Time of Randomization. Trial comparisons, record NCT01411852-ea0edebf. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01411852-ea0edebf
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.253 | 0.176 | 0.348 | wilson | |
| Risk in group 2 | 0.0928 | 0.0496 | 0.167 | wilson | |
| Risk difference, group 1 minus group 2 | 0.16 | 0.0532 | 0.265 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.72 | 1.34 | 5.55 | log | |
| Odds ratio, group 1 over group 2 | 3.31 | 1.44 | 7.56 | log | |
| Number needed to treat, for one more participant with the outcome on Standard Resuscitation (SR) than on Controlled Resuscitation (CR) | 6.26 | 3.77 | 18.8 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Standard Resuscitation (SR) | Patients in the SR group received 2 liters of fluid as an initial bolus. Following the initial bolus, additional fluid was given a needed to maintain a SBP of 110 mmHg for the duration of the study period. | 24 | 95 | OG000 |
| Group 2 | Controlled Resuscitation (CR) | Patients in the CR group received a 250 milliliter (ml) bolus of saline only if their SBP was \< 70 millimeters of mercury (mmHg) or they had no palpable radial pulse. | 9 | 97 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Ineligible Patients Enrolled at the Time of Randomization
- Description
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
- Time frame
- From the time the paramedic with study drug kit arrived at patient's side to the time kit was opened prior to ED arrival
- Population
- All patients enrolled in the study.
Source ClinicalTrials.gov
Trial
- Title
- Field Trial of Hypotensive Versus Standard Resuscitation for Hemorrhagic Shock After Trauma
- NCT number
- NCT01411852
- Phases
- PHASE2
- Conditions
- Blunt Trauma, Penetrating Wound, Hemorrhagic Shock
- Interventions
- 0.9% Sodium Chloride 250 mL bolus, 0.9% Sodium Chloride 2000 mL bolus
- Lead sponsor
- University of Washington
- Results first posted
- 2014-10-20
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01411852?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
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
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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