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NCT01611935 · ClinicalTrials.gov registry record · Phase 2
AVERT Shock: Arginine Vasopressin During the Early Resuscitation of Traumatic Shock
A Phase 2 study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- Phase 2
- Development phase
- 101
- Enrollment target
NCT01611935: Completed Phase 2 study, sponsored by University of Pennsylvania.
NCT01611935 is a Phase 2 study that has completed, run by University of Pennsylvania. The registered enrollment target is 101 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01611935, a Phase 2 study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 101 participants
- Enrollment target
Study Summary
Trauma patients, who are transfused with multiple blood products to treat shock due to blood loss, frequently develop inappropriately low vasopressin levels. Vasopressin is a hormone necessary to maintain an adequate blood pressure and low levels have been associated with the need for increased transfusions, vasopressors and additional morbidity. Vasopressin is routinely used in the ICU to treat septic shock and other disease processes resulting in decreased vasopressin levels and low blood pressure. This study will investigate the potential benefit of early vasopressin supplementation during the resuscitation of trauma patients and the applicability of using copeptin as a vasopressin biomarker. Trauma patients who receive 6 or more units of blood product within 12 hours of arrival will be randomized to receive a vasopressin bolus plus infusion or a similar volume of a placebo (normal saline) for 48 hours. Serial blood samples will be taken for 5 days post-injury. Clinical and demographic data will be recorded prospectively.
Primary Outcome
Cumulative number of units of blood products, including packed red blood cells, plasma and platelets measured in liters
Interventions
- DRUG Vasopressin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 101 participants |
| Start Date | 2013-05-01 |
| Est. Completion | 2016-09-06 |
| Phase | Phase 2 |
What the finished NCT01611935 record still lists
NCT01611935 is an interventional study that assigns participants to a tested intervention. The registered 101 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (24% lower).
The record links to 0 conditions, and to 1 intervention - of which Vasopressin is the first listed.
NCT01611935 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01611935 about?
NCT01611935 is a clinical study titled "AVERT Shock: Arginine Vasopressin During the Early Resuscitation of Traumatic Shock". Trauma patients, who are transfused with multiple blood products to treat shock due to blood loss, frequently develop inappropriately low vasopressin levels. Vasopressin is a hormone necessary to maintain an adequate blood pressure and low levels have been associated with the need for increased tran...
What is the current status of trial NCT01611935?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 101 participants. The study started on 2013-05-01. Estimated completion is 2016-09-06.
What interventions are being tested in trial NCT01611935?
The interventions under investigation include: Vasopressin (DRUG).
Who is sponsoring clinical trial NCT01611935?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01611935's enrollment target sits among peer trials
101 672nd of 2000 higher than 1,329 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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