Comparison · NCT01411852-sae
Standard Resuscitation (SR) vs Controlled Resuscitation (CR): serious adverse events
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): serious adverse events. Trial comparisons, record NCT01411852-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01411852-sae
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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 | 0.0842 | 0.0433 | 0.157 | wilson | |
| Risk in group 2 | 0.188 | 0.122 | 0.277 | wilson | |
| Risk difference, group 1 minus group 2 | -0.103 | -0.202 | -0.00505 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.449 | 0.205 | 0.983 | log | |
| Odds ratio, group 1 over group 2 | 0.398 | 0.164 | 0.968 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Standard Resuscitation (SR) than on Controlled Resuscitation (CR) | 9.68 | 4.96 | 198 | 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. | 8 | 95 | EG000 |
| 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.~The total number of patients at risk is one less than the total number of patients enrolled. Regulatory restrictions for prisoners required that no data collection, including severe adverse events, be performed for the patient who was determined to have been in police custody at the time of enrollment. | 18 | 96 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Data were collected from the time the blinded study fluid kit was opened by the paramedic prior to hospital arrival to discharge, an average hospital stay of 7.6 days (SD 13.2).
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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