Comparing pooled human plasma and crystalloid for children undergoing spinal fusion for scoliosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Understanding Proteins and Skepsis Progression in Adolescent Scoliosis

  Researchers will test blood protein markers to see if they can predict scoliosis progression in teens with AIS or neuromuscular scoliosis.

  Recruiting University of Colorado, Denver · Aurora, Colorado · NCT07634627

• Erector spinae plane block to reduce post-operative pain after posterior spinal fusion in children

  This will try giving an erector spinae plane block with ropivacaine to see if it reduces pain and the need for opioid pain medicine after posterior spinal fusion in children with adolescent idiopathic or neuromuscular scoliosis.

  Recruiting Phase 3 University of California, San Francisco · San Francisco, California · NCT07561827

• Turkish version of the Scoliosis Misconception Scale for adolescents with AIS

  This study tests a Turkish version of the Scoliosis Misconception Scale in 200 adolescents with AIS to see if the questions reliably measure misconceptions about scoliosis.

  Recruiting Kahramanmaras Sutcu Imam University · Kahramanmaraş, Kahramanmaraş · NCT07909174

• Hypnosis to reduce pain and nausea after scoliosis surgery in teens

  Teens aged 12–18 undergoing scoliosis surgery will try preoperative hypnosis to see if it lowers pain, nausea, and opioid use after surgery.

  Recruiting St. Olavs Hospital · Trondheim · NCT07854951

• Supervised vs. Home Schroth Exercises for Adolescent Idiopathic Scoliosis

  This study tests whether supervised Schroth exercises work better than a home-based program for teens with AIS.

  Recruiting Bitlis Eren University · Siliviri, Istanbul · NCT07779070

• Sleep quality in adolescents with scoliosis

  This study tests whether adolescents with idiopathic scoliosis have different sleep quality than healthy peers aged 10–18.

  Recruiting Bezmialem Vakif University · Istanbul · NCT07767591

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.