Comparing pooled human plasma and crystalloid for children undergoing spinal fusion for scoliosis
Pooled Human Plasma vs Crystalloid in The Management of Children Undergoing Instrumented Spinal Fusion for Scoliosis: A Double-Blind, Randomized Clinical Trial
This study is testing whether using pooled human plasma instead of a standard fluid can help reduce blood loss during spinal surgery for scoliosis in teenagers.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 194 (estimated) |
| Ages | 10 Years to 21 Years |
| Sex | All |
| Sponsor | Turku University Hospital Government |
| Locations | 2 sites (Helsinki and 1 other locations) |
| Trial ID | NCT06934278 on ClinicalTrials.gov |
What this trial studies
The OCTAGON trial is a Phase 3, randomized, double-blinded, parallel-group clinical trial that aims to evaluate the effectiveness of pooled human plasma versus crystalloid in reducing intraoperative blood loss in adolescents undergoing spinal fusion surgery for scoliosis. A total of 194 participants aged 10 to 21 years with significant scoliosis curves will be enrolled and monitored for outcomes such as blood loss, need for blood transfusions, and postoperative recovery metrics over a minimum follow-up period of two years. The study will also assess the safety of pooled human plasma by recording any adverse events during the trial.
Who should consider this trial
Good fit: Ideal candidates for this study are adolescents aged 10 to 21 years with idiopathic or neuromuscular scoliosis requiring posterior spinal surgery.
Not a fit: Patients with conditions such as immunoglobulin A deficiency, severe obesity, or those requiring more complex surgical interventions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly reduce the need for blood transfusions and improve surgical outcomes for children undergoing spinal fusion for scoliosis.
How similar studies have performed: While the use of pooled human plasma in pediatric surgery is less explored, similar studies in adult populations have shown promising results in reducing blood loss during major surgeries.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Helsinki and 1 other locations
- Helsinki University Hospital — Helsinki, Finland (Recruiting)
- Turku University Hospital — Turku, Finland (Recruiting)
Study contacts
- Principal investigator: Matti Ahonen, MD, Ass Prof, Ortho surgeon — Helsinki University Central Hospital
- Study coordinator: Ilkka Helenius, MD, orthopaedic surgeon
- Email: ilkka.helenius@helsinki.fi
- Phone: +358443380034
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.