Vasopressin in Traumatic Hemorrhagic Shock Study

What Was Tested

The trial (phase 2, phase 3) is built around Vasopressin.

The purpose of the present trial is therefore to assess effects of arginine vasopressin vs. saline placebo on hospital admission rate (primary end point), as well as hemodynamic variables, fluid resuscitation requirements and hospital discharge rate (secondary study end points) in presumed traumatic hemorrhagic shock patients with a systolic arterial blood pressure \<90 mm Hg after 10 min of standard shock treatment.

Accordingly, the study reflects an add-on design to standard traumatic shock therapy.

The hypothesis is that both arginine vasopressin and saline placebo have comparable effects on hemodynamic variables, fluid resuscitation requirements, and hospital admission and discharge rate.

It had two arms (groups): Vasopressin (active comparator) and Saline (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

The study will be designed as a multicenter, randomized, placebo-controlled clinical trial with blinded assessment of the outcome in a study network with helicopter emergency medical service units in Austria, Germany, Switzerland, Italy, Czech Republic and the Netherlands.

The protocol, information and consent procedure will be approved by the institutional review board of each participating center.

Treatment assignments of blinded study drugs will be randomly generated by computer in blocks of two, with stratification according to center.

Before the start of the trial, staff at participating centers will be informed about the rationale of the protocol and the study; participating centers will be subsequently contacted and visited to ensure proper enrollment.

Who Took Part

Enrollment: 64 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

The full record lists 1 inclusion and 10 exclusion criteria; among the exclusions: terminal illness; no intravenous access; age \< 18 years.

How the Study Was Run

The set-up was randomized, single-group and double-blind.

The participants were allocated by chance, so the Vasopressin group and the comparison group should start out alike.

As a double-blind Vasopressin study, the assignments were hidden from both participants and investigators until the end.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

Those kept unaware of assignments: participant and care provider.

It started in 2010-07 with completion listed for 2014-10.

It ran at 14 sites in Austria (8) and Germany (6).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Primary end point will be hospital admission rate (time frame: time from trauma to hospital admission).

It also tracked 3 secondary outcomes, for example Hemodynamic variables, Fluid resuscitation requirements and Hospital discharge rate.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Vasopressin in 64 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Vasopressin compound page, all human trials.