Safety and Tolerability of Volplex® in Elective Surgery

Abstract

Objective: Succinylated gelatin is widely used in the management of hypovolaemic conditions. Volplex® is a new presentation of succinylated gelatin in a flexible, collapsible bag, which is sterilised at 121°C. This study aimed to document the safety and tolerability of Volplex®, using Gelofusine® as a control, in elective surgery.

Design and patients: The study was a single-centre, open-label, randomised, parallel-group trial that included patients aged 18–75 years who were, in the opinion of the investigator, likely to need an infusion of a colloid as part of their surgical management. The patients were randomised to receive either Volplex® or Gelofusine® in a 2: 1 ratio in favour of Volplex®. Three assessments, preoperative, perioperative and 24 hours following anaesthetic induction, were performed. All statistical testing was two-sided and performed at a 5% level of significance.

Results: 76 patients (52 receiving Volplex® and 24 receiving Gelofusine®) were included in the intent-to-treat population. The volumes of fluids infused were 1154mL and 1115mL for the Volplex® and Gelofusine® groups, respectively, of which 962mL was Volplex® and 958mL was Gelofusine®, respectively. Patients also received crystalloids and blood and there were no significant differences between groups in the amounts received. Eighteen Volplex® recipients (35%) and 12 Gelofusine® recipients (50%) reported at least one adverse event. Of the 27 events reported for Volplex®, 15 (56%) were considered not related and 12 (44%) possibly related to Volplex®. In the case of Gelofusine®, 17 events were reported, and of these eight (47%) were considered not related and nine (53%) possibly related to Gelofusine®. None of the reported adverse events were considered probably related to either colloid. One serious adverse event, mild hypothermia, was reported in the Gelofusine® group. The unexpected length of surgery was stated as the causal factor. There were no significant differences between Volplex® and Gelofusine® with regard to the number of patients with out-of-range laboratory values postoperatively. Urine output for both groups was reduced postoperatively, but there were no major differences between the groups observed.

Conclusion: This small, open-label study showed that Volplex®, a new presentation of succinylated gelatin, was comparable to a well-established brand, Gelofusine® when used in the management of patients undergoing elective surgery.