Comparison of OctaplasLG and Plasma-Lyte 148 in Fluid Management for Pediatric Instrumented Spinal Fusion in Neuromuscular and Adolescent Idiopathic Scoliosis

The primary objective of this double-blind, randomized clinical trial is to quantify the efficacy of **OCTAPLAS** infusion in reducing intraoperative blood loss compared to **PLASMALYTE** in pediatric subjects undergoing instrumented spinal fusion for scoliosis. This is clinically relevant as minimizing blood loss during surgery can reduce the need for blood transfusions and associated complications, thereby improving surgical outcomes and recovery in children with **neuromuscular scoliosis** and **adolescent idiopathic scoliosis**. No secondary objectives are specified for this study.

The clinical trial involves a study population comprising **scoliosis** patients aged between 10 to 21 years, including both male and female subjects. The trial focuses on individuals diagnosed with either **adolescent idiopathic scoliosis** or **neuromuscular scoliosis** with a curvature greater than 45 degrees, who are undergoing posterior spinal fusion using the pedicle screw technique. The sponsor has not provided information regarding the total number of participants. The trial population was selected based on specific inclusion criteria, targeting a vulnerable population due to the nature of the medical condition and the surgical intervention involved. Participants' general health status and lifestyle considerations such as diet, physical activity, or habits have not been detailed in the available data.

The clinical trial is designed as a **randomized**, **double-blind**, controlled study to evaluate the efficacy of OCTAPLAS infusion in reducing intraoperative blood loss compared to PLASMALYTE in patients undergoing posterior spinal fusion for scoliosis. The trial targets individuals aged 10 to 21 years with **adolescent idiopathic scoliosis** or **neuromuscular scoliosis** exceeding 45 degrees, treated using the pedicle screw technique. The primary endpoint is the measurement of intraoperative blood loss, while secondary endpoints include the need for allogenic red blood cell infusion, health-related quality of life, postoperative pain, operative time, drain output, hidden blood loss, hospital stay, and complications such as skin reactions and deep surgical site infections.

The trial is expected to commence recruitment on September 1, 2024, and conclude by December 31, 2029. Participants will be involved in the study for a maximum treatment period of one day, with the administration of the investigational products via **intravenous infusion**. The study visits will include an initial screening visit to confirm eligibility based on the inclusion criteria, followed by the treatment visit where the investigational product is administered. Follow-up visits will be scheduled to monitor the secondary endpoints and assess any adverse events. The end-of-study visit will occur after the final follow-up to collect comprehensive data on the primary and secondary outcomes.

Participants may be withdrawn from the study if they experience significant adverse reactions, fail to comply with the study protocol, or if the investigator deems it necessary for their safety. The trial is conducted under Phase 4, ensuring rigorous evaluation of the investigational products' safety and efficacy in the specified patient population. The study's design and methodology adhere to ethical standards and regulatory requirements, ensuring the integrity and reliability of the trial outcomes.

The clinical trial involves the administration of **Plasma-Lyte® 148 (pH 7.4) solution for infusion**, which is a crystalloid solution used as a comparator treatment. This solution is composed of several active substances, including **magnesium chloride hexahydrate**, **potassium chloride**, **sodium chloride**, **sodium acetate trihydrate**, and **sodium gluconate**. The pharmaceutical form of this product is a solution for infusion, and it is administered via **intravenous infusion**. The dosage is calculated based on the participant's body weight, with a maximum daily dose of 10 milliliters per kilogram. The maximum treatment period is limited to one day. The solution is manufactured by Baxter Healthcare Ltd. and is not a pediatric formulation.

The experimental treatment in this trial is **octaplasLG**, a pooled human plasma product used as the test treatment. This product is a solution for infusion containing **human plasma protein** as its active substance. It is also administered through **intravenous infusion**. Similar to the comparator, the dosage is determined by the participant's body weight, with a maximum daily dose of 10 milliliters per kilogram, and the treatment period is restricted to one day. OctaplasLG is produced by Octapharma AB and is derived from blood, making it a structurally diverse substance. This product is also not formulated for pediatric use.

The efficacy of the clinical trial will be assessed by evaluating the primary and secondary endpoints. The primary endpoint is the measurement of intraoperative blood loss, quantified in milliliters, after wound closure in patients undergoing posterior spinal fusion for scoliosis. This will provide a direct measure of the efficacy of **OCTAPLAS** infusion compared to **PLASMALYTE** in reducing blood loss during surgery.

Secondary endpoints include a range of parameters that will be assessed to provide a comprehensive evaluation of the treatment's efficacy. These include the need for allogenic red blood cell infusion, measured as the percentage of patients requiring transfusion at hospital release. Health-related quality of life will be assessed using the Scoliosis Research Society 24 outcome questionnaire. Postoperative pain will be evaluated through 48-hour opioid consumption and a pain visual analogue score. Additional secondary endpoints include operative time in hours, drain output in milliliters, hidden blood loss in milliliters, length of hospital stay, and the incidence of complications such as skin reactions, transfusion-related acute lung injury (TRALI), and deep surgical site infections.