OBJECTIVE:Succinylated gelatin is widely used in the management of hypovolaemic conditions. Volplex((R)) is a new presentation of succinylated gelatin in a flexible, collapsible bag, which is sterilised at 121 degrees C. This study aimed to document the safety and tolerability of Volplex((R)), using Gelofusine((R)) 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((R)) or Gelofusine((R)) in a 2 : 1 ratio in favour of Volplex((R)). 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((R)) and 24 receiving Gelofusine((R))) were included in the intent-to-treat population. The volumes of fluids infused were 1154mL and 1115mL for the Volplex((R)) and Gelofusine((R))groups, respectively, of which 962mL was Volplex((R)) and 958mL was Gelofusine((R)), respectively. Patients also received crystalloids and blood and there were no significant differences between groups in the amounts received. Eighteen Volplex((R)) recipients (35%) and 12 Gelofusine((R)) recipients (50%) reported at least one adverse event. Of the 27 events reported for Volplex((R)), 15 (56%) were considered not related and 12 (44%) possibly related to Volplex((R)). In the case of Gelofusine((R)), 17 events were reported, and of these eight (47%) were considered not related and nine (53%) possibly related to Gelofusine((R)). None of the reported adverse events were considered probably related to either colloid. One serious adverse event, mild hypothermia, was reported in the Gelofusine((R)) group. The unexpected length of surgery was stated as the causal factor. There were no significant differences between Volplex((R)) and Gelofusine((R)) 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((R)), a new presentation of succinylated gelatin, was comparable to a well-established brand, Gelofusine((R))when used in the management of patients undergoing elective surgery.
RCT Entities:
OBJECTIVE: Succinylated gelatin is widely used in the management of hypovolaemic conditions. Volplex((R)) is a new presentation of succinylated gelatin in a flexible, collapsible bag, which is sterilised at 121 degrees C. This study aimed to document the safety and tolerability of Volplex((R)), using Gelofusine((R)) 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((R)) or Gelofusine((R)) in a 2 : 1 ratio in favour of Volplex((R)). 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((R)) and 24 receiving Gelofusine((R))) were included in the intent-to-treat population. The volumes of fluids infused were 1154mL and 1115mL for the Volplex((R)) and Gelofusine((R))groups, respectively, of which 962mL was Volplex((R)) and 958mL was Gelofusine((R)), respectively. Patients also received crystalloids and blood and there were no significant differences between groups in the amounts received. Eighteen Volplex((R)) recipients (35%) and 12 Gelofusine((R)) recipients (50%) reported at least one adverse event. Of the 27 events reported for Volplex((R)), 15 (56%) were considered not related and 12 (44%) possibly related to Volplex((R)). In the case of Gelofusine((R)), 17 events were reported, and of these eight (47%) were considered not related and nine (53%) possibly related to Gelofusine((R)). None of the reported adverse events were considered probably related to either colloid. One serious adverse event, mild hypothermia, was reported in the Gelofusine((R)) group. The unexpected length of surgery was stated as the causal factor. There were no significant differences between Volplex((R)) and Gelofusine((R)) 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((R)), a new presentation of succinylated gelatin, was comparable to a well-established brand, Gelofusine((R))when used in the management of patients undergoing elective surgery.