Pooled Human Plasma vs Crystalloid in The Management of Children Undergoing Instrumented Spinal Fusion for Scoliosis

Launched by TURKU UNIVERSITY HOSPITAL · Apr 17, 2025

Keywords

ClinConnect Summary

The OCTAGON trial is a clinical study looking at the best way to manage bleeding during spinal surgery for adolescents with scoliosis. Specifically, it compares two types of fluids given before surgery: pooled human plasma and a saline solution called Plasmalyte. Researchers want to see if using pooled human plasma can reduce blood loss during surgery and lower the need for blood transfusions. The trial will involve 194 teenagers aged 10 to 21 who are undergoing spinal fusion surgery due to scoliosis curves that are considered significant.

To participate, young patients must have scoliosis that requires surgery, and they should not have certain medical conditions, such as severe allergies or issues with blood clotting. Throughout the trial, doctors will monitor various factors, including how much blood is lost during surgery, how long the surgery takes, and any complications that may arise. Parents will be involved in the process, and their presence will be welcomed to ensure comfort and support for their child. The study has been approved by regulatory authorities, and the findings will be shared in reputable medical journals to help improve future care for scoliosis patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Written informed consent.
• • Aged between 10 and 21 years of age
• • Scoliosis requiring posterior scoliosis surgery using all pedicle screw technique for AIS (\>45-degree major curve) or NMS (\>50-degree major curve)
• • Normal whole spine MRI except for the spinal deformity (only for patients with adolescent idiopathic scoliosis as patients with neuromuscular scoliosis do not typically undergo MR images as they would need general anaesthesia)
• Exclusion Criteria:
• • Immunoglobulin A-deficiency
• • Need for anteroposterior surgery
• • Need for three column vertebral resection
• • Smoking
• • Diabetes mellitus
• • Abnormalities in blood coagulation (thromboplastin time below above or below of normal values, 70-130%)
• • Blood trombosytes less than 150 x E9/l
• • Body mass index over 40
• • Allergy or hypersensitivity to study medications or their ingredients
• • Pregnancy or breast-feeding, aim of becoming pregnant during the study.
• • Participation in another study and receipt of any other investigational agent during 2 year period of current investigation
• • Inability to provide written informed consent
• • Any significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk by participation in the study, or may influence the result of the study.
• • A history of drug or alcohol use that, in the opinion of the investigator, would interfere with adherence to study requirements.
• • Known history of, or documented positive hepatitis B or C or HIV infection Prior or concurrent malignancy
• • Aspartate transaminase (AST) or alanine transaminase (ALT) ≥ 3 x upper-limit of normal
• • Creatinine clearance (CrCl) \< 60 ml/min measured by 24-hour urine collection or estimated from the Cockcroft and Gault formula
• • Clinically significant ECG findings as judged by the investigator
• • Amiodarone medication
• • Hyperkalemia
• • Renal insufficiency
• • AV-block
• • Metabolic or respiratory alkalosis
• • Hypochlorhydria
• • Hypersensitivity for active component or additives.