Argipressin for prevention of blood loss during liver resection: a study protocol for a randomised, placebo-controlled, double-blinded trial (ARG-01)

What Was Tested

This clinical study looks at Vasopressin.

The study is enrolling patients since March 2022.

The trial is approved by the Swedish Ethical Review Authority (Dnr 2021-03557) and the Swedish Medical Product Agency (Dnr 5.1-2021-90115).

Who Took Part

The study group was 248 patients.

ARG-01 is a prospective, randomised, placebo-controlled, double-blinded study on 248 patients undergoing liver resection at Sahlgrenska University Hospital, Sweden.

Patients will be randomised to one of two parallel groups, infusion of argipressin or normal saline administered peroperatively.

How the Study Was Run

The design is described as randomized, double-blind, placebo-controlled and parallel-group.

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

Neither the patients nor the staff measuring them knew who was on Vasopressin, so expectations could not easily colour the readings.

The comparison arm used a placebo, so changes seen with Vasopressin could be set against what happens without it.

The Vasopressin group and the comparison group ran side by side rather than switching.

The primary endpoint is peroperative blood loss.

Secondary outcomes include need for blood transfusion, perioperative variables, length of hospital stay, the inflammatory response, organ damage markers and complications at 30 days.

What Was Measured

Topics PubMed links to this paper include Arginine Vasopressin, Hepatectomy, Liver, Hemorrhage and Randomized Controlled Trials as Topic.

Author keywords: Acute renal failure, Adult anaesthesia, Blood bank & transfusion medicine, Clinical Trial, Gastrointestinal tumours and Hepatobiliary surgery.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Vasopressin in 248 patients.

The publication is from 2023 (BMJ open), a journal based in England.

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