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https://pubmed.ncbi.nlm.nih.gov/31497522Actively Recruiting
Phase 3
Age: 10Years - 21Years
All Genders
ID06934278
Pooled Human Plasma vs Crystalloid in The Management of Children Undergoing Instrumented Spinal Fusion for Scoliosis: A Double-Blind, Randomized Clinical Trial
Led by Turku University Hospital · Updated on 2025-05-07
194
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
T
Turku University Hospital
Lead Sponsor
H
Helsinki University Central Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
The OCTAGON trial is a randomized, double-blind, multicenter clinical study evaluating the use of pooled human plasma compared to crystalloid fluids in adolescents aged 10 to 21 years undergoing posterior spinal fusion surgery for adolescent idiopathic scoliosis (AIS) or neuromuscular scoliosis (NMS). The study aims to determine if pooled human plasma can reduce intraoperative blood loss and the need for blood transfusions while monitoring safety and quality of life over a minimum two-year follow-up period. Participants are randomly assigned to receive either pooled human plasma (Octaplas) or a placebo crystalloid solution (Plasmalyte) as an intravenous infusion of 10 mL/kg (up to 400 mL) over one hour before surgery. The surgery involves spinal fusion using pedicle screws, and standard anesthesia and pain management protocols are followed. The study includes extensive blinding procedures and safety monitoring, including the possibility of unblinding if severe adverse events occur. During the study, participants undergo regular assessments including measurements of blood loss during and after surgery, pain levels, opioid consumption, and quality of life questionnaires at baseline, 6 months, and 24 months post-surgery. Safety evaluations include monitoring for allergic reactions, infections, and other complications. The trial ends 24 months after the last participant's surgery, with ongoing data collection and safety oversight by an independent monitoring board.
CONDITIONS
Brief Title
Pooled Human Plasma vs Crystalloid in The Management of Children Undergoing Instrumented Spinal Fusion for Scoliosis
Who Can Participate
Age: 10Years - 21Years
All Genders
Eligibility Criteria
You may qualify if you...
- Written informed consent
- Aged between 10 and 21 years
- Scoliosis requiring posterior scoliosis surgery using all pedicle screw technique for AIS (major curve >45 degrees) or NMS (major curve >50 degrees)
- Normal whole spine MRI except for the spinal deformity (only for AIS patients)
You will not qualify if you...
- Immunoglobulin A-deficiency
- Need for anteroposterior surgery
- Need for three column vertebral resection
- Smoking
- Diabetes mellitus
- Abnormalities in blood coagulation (thromboplastin time outside 70-130%)
- Blood thrombocytes less than 150 x 10^9/l
- Body mass index over 40
- Allergy or hypersensitivity to study medications or their ingredients
- Pregnancy, breastfeeding, or aiming to become pregnant during the study
- Participation in another study or receipt of investigational agents in past 2 years
- Inability to provide written informed consent
- Significant disease or disorder that increases risk or affects study results
- History of drug or alcohol use interfering with study adherence
- Known hepatitis B, C, or HIV infection
- Prior or concurrent malignancy
- Elevated liver enzymes (AST or ALT ≥ 3 times upper limit)
- Reduced kidney function (creatinine clearance < 60 ml/min)
- Clinically significant ECG abnormalities
- Amiodarone medication
- Hyperkalemia
- Renal insufficiency
- AV-block
- Metabolic or respiratory alkalosis
- Hypochlorhydria
- Hypersensitivity to active components or additives
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility assessments including informed consent and MRI for AIS patients
Treatment
Duration - Day of surgery
Participants receive either pooled human plasma or crystalloid infusion over 1 hour during anesthesia before scoliosis surgery. Surgery and anesthesia are conducted according to standard procedures while monitoring blood loss and vital signs.
1 visit (in-person) on surgery day including infusion and surgery
Post-operative Follow-up
Duration - Up to 5 days post-surgery
Participants are monitored in the hospital for up to 5 days after surgery for blood loss, pain management, wound care, and adverse events. Assessments include hemoglobin levels, drain output, pain scores, and opioid use.
Daily hospital visits for postoperative care and assessments
Long-term Monitoring
Duration - 24 months
Participants attend outpatient visits at 6 and 24 months after surgery for health-related quality of life assessments, scoliosis radiographs, pain evaluation, and safety monitoring.
2 outpatient visits at 6 and 24 months post-surgery
Trial Site Locations
Total: 2 locations
1
Helsinki University Hospital
Helsinki, Finland, FI-00029
Actively Recruiting
2
Turku University Hospital
Turku, Finland, 20900
Actively Recruiting
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Research Team
I
Ilkka Helenius, MD, orthopaedic surgeon
T
Tanja Perokorpi, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Tranexamic Acid Is Efficacious at Decreasing the Rate of Blood Loss in Adolescent Scoliosis Surgery: A Randomized Placebo-Controlled Trial.
Susan M Goobie, David Zurakowski, Michael P Glotzbecker...
https://pubmed.ncbi.nlm.nih.gov/30516625Gelatine matrix with human thrombin decreases blood loss in adolescents undergoing posterior spinal fusion for idiopathic scoliosis: a multicentre, randomised clinical trial.
I Helenius, H Keskinen, J Syvänen...
https://pubmed.ncbi.nlm.nih.gov/26920966Back Pain and Quality of Life After Surgical Treatment for Adolescent Idiopathic Scoliosis at 5-Year Follow-up: Comparison with Healthy Controls and Patients with Untreated Idiopathic Scoliosis.
Linda Helenius, Elias Diarbakerli, Anna Grauers...
https://pubmed.ncbi.nlm.nih.gov/31436653Postoperative outcomes of pedicle screw instrumentation for adolescent idiopathic scoliosis with and without a subfascial wound drain: a multicentre randomized controlled trial.
Linda Helenius, Paul Gerdhem, Matti Ahonen...
https://pubmed.ncbi.nlm.nih.gov/36047026A retrospective cohort study of bleeding characteristics and hidden blood loss after segmental pedicle screw instrumentation in neuromuscular scoliosis as compared with adolescent idiopathic scoliosis.
Venla Soini, Arimatias Raitio, Ilkka Helenius...
https://pubmed.ncbi.nlm.nih.gov/36561891Mortality and Causes of Death in Children With Cerebral Palsy With Scoliosis Treated With and Without Surgery.
Matti Ahonen, Ilkka Helenius, Mika Gissler...
https://pubmed.ncbi.nlm.nih.gov/37679048