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

NCT06934278 | Recruiting Phase 3 DMC

• 1 other identifier: T/210/2024
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 2

Brief Summary

OCTAGON trial is a randomized, double-blinded, parallel-group non-inferiority multicenter (Helsinki and Turku University Hospitals, Finland) clinical trial according to CONSORT criteria. 194 adolescents with idiopathic (major curve \> 45 degrees) or neuromuscular scoliosis (major curve \> 50 degrees) are enrolled for the OCTAGON trial comparing pooled human plasma (Octaplas, 10mL/kg, active management) vs. Plasmalyte (10 mL/kg, placebo) before incision as part of the normal intraoperative fluid therapy. Data is collected at baseline and at each follow-up until a minimum of 2-year follow-up. Outcomes Outcomes for the OCTAGON trial include 1) intraoperative blood loss (in mL, primary outcome) and the need for allogenic red blood cell infusion (percentage of patients). Secondary outcomes include health-related quality of life (Scoliosis Research Society 24 outcome questionnaire), postoperative pain (48-hour opioid consumption), operative time (hours), drain output (mL), hidden blood loss (mL), hospital stay, and complications (skin reactions, TRALI, deep surgical site infection, neurologic deficit). Research questions and hypothesis Does prophylactic use of pooled human plasma decrease intraoperative blood loss in adolescents undergoing instrumented spinal fusion for scoliosis? We hypothesize that pooled human plasma will reduce intraoperative and total blood loss by 25% resulting in lower need for blood transfusion and fewer surgical site infections. Objectives To compare the effect of pooled human plasma vs. crystalloid fluids on intraoperative bleeding and total blood loss (drain output and hidden blood loss) in children undergoing posterior spinal fusion for AIS and NMS. Adverse events will be recorded and reported as minor (skin reaction) or major (severe allergic reaction, transfusion related acute lung injury, TRALI, deep surgical site infection, neurologic injury). Ethical aspects The PHP trial has been evaluated via European regulatory authority (EU CT: 2024-514857-31-00) and by Fimea (FIMEA/2024/006588). Informed consent is obtained from the parent(s). Results will be disseminated in high-quality peer-reviewed publications. The individual patient safety and high-quality management of fractures and scoliosis is a priority in this trial. The randomization can be opened at any stage of the treatment process. Based on the clinical decision the randomized treatment can be terminated and treatment provided accord-ing to clinical decision making even if results will be evaluated using the intention to treat princi-ple. Pain management will be prioritized in every clinical scenario and parental presence is always possible.

Conditions

Adolescent Idiopathic Scoliosis (AIS); Neuromuscular Scoliosis

Keywords

adolescent idiopathic scoliosis; neuromuscular scoliosis; pooled human plasma; randomized clinical trial; double-blind placebo controlled

Outcome Measures

Primary Outcomes (1)

• Intraoperative blood loss

  Bleeding during surgery (milliliters, mL). Typical intraoperative blood loss ranges 500 mL to 3000 mL representing 20% to 75% blood loss out of total blood volume. Higher blood loss during surgery is associated with worse outcomes.

  Exposure to closure

Secondary Outcomes (4)

• Total blood loss

  From exposure to drain removal at 24 hours postoperatively

• Need for allogeneic blood transfusion

  From surgical exposure to 72 hours postoperatively

• Health-related quality of life

  At 6 and 24 months

• Adverse events

  From surgery to 2-year follow-up

Study Arms (2)

Pooled human plasma

ACTIVE COMPARATOR

Pooled human plasma (Octaplas, 10mL/kg, max 400 mL)

Drug: Pooled human plasma

Placebo

PLACEBO COMPARATOR

Crystalloid infusion (Plasmalyte, 10 mL/kg, max 400 mL)

Drug: Placebo

Interventions

Pooled human plasma DRUG

Infusion of pooled human plasma (Octaplas, 10 mL/kg, max 400 mL) over 1 hour after induction of general anaesthesia

Pooled human plasma

Placebo DRUG

Infusion of cryst (Octaplas, 10 mL/kg, max 400 mL) over 1 hour after induction of general anaesthesia

Placebo

Eligibility Criteria

• Age: 10 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Turku University Hospital: lead
• Helsinki University Central Hospital: collaborator

Study Sites (2)

Helsinki University Hospital

Helsinki, FI-00029, Finland

RECRUITING

Turku University Hospital

Turku, 20900, Finland

RECRUITING

Related Publications (7)

• Javaherforoosh Zadeh F, Janatmakan F, Shafaee Tonekaboni M, Soltanzadeh M. The Effect of Fibrinogen on Blood Loss After Lumbar Surgery: A Double-Blind Randomized Clinical Trial. Anesth Pain Med. 2019 Jun 1;9(3):e91199. doi: 10.5812/aapm.91199. eCollection 2019 Jun.

  PMID: 31497522 BACKGROUND

• Goobie SM, Zurakowski D, Glotzbecker MP, McCann ME, Hedequist D, Brustowicz RM, Sethna NF, Karlin LI, Emans JB, Hresko MT. Tranexamic Acid Is Efficacious at Decreasing the Rate of Blood Loss in Adolescent Scoliosis Surgery: A Randomized Placebo-Controlled Trial. J Bone Joint Surg Am. 2018 Dec 5;100(23):2024-2032. doi: 10.2106/JBJS.18.00314.

  PMID: 30516625 BACKGROUND

• Helenius I, Keskinen H, Syvanen J, Lukkarinen H, Mattila M, Valipakka J, Pajulo O. Gelatine matrix with human thrombin decreases blood loss in adolescents undergoing posterior spinal fusion for idiopathic scoliosis: a multicentre, randomised clinical trial. Bone Joint J. 2016 Mar;98-B(3):395-401. doi: 10.1302/0301-620X.98B3.36344.

  PMID: 26920966 BACKGROUND

• Helenius L, Diarbakerli E, Grauers A, Lastikka M, Oksanen H, Pajulo O, Loyttyniemi E, Manner T, Gerdhem P, Helenius I. Back 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. J Bone Joint Surg Am. 2019 Aug 21;101(16):1460-1466. doi: 10.2106/JBJS.18.01370.

  PMID: 31436653 BACKGROUND

• Helenius L, Gerdhem P, Ahonen M, Syvanen J, Jalkanen J, Charalampidis A, Nietosvaara Y, Helenius I. Postoperative outcomes of pedicle screw instrumentation for adolescent idiopathic scoliosis with and without a subfascial wound drain: a multicentre randomized controlled trial. Bone Joint J. 2022 Sep;104-B(9):1067-1072. doi: 10.1302/0301-620X.104B9.BJJ-2022-0391.R1.

  PMID: 36047026 BACKGROUND

• Soini V, Raitio A, Helenius I, Helenius L, Syvanen J. A retrospective cohort study of bleeding characteristics and hidden blood loss after segmental pedicle screw instrumentation in neuromuscular scoliosis as compared with adolescent idiopathic scoliosis. N Am Spine Soc J. 2022 Dec 5;12:100190. doi: 10.1016/j.xnsj.2022.100190. eCollection 2022 Dec.

  PMID: 36561891 BACKGROUND

• Ahonen M, Helenius I, Gissler M, Jeglinsky-Kankainen I. Mortality and Causes of Death in Children With Cerebral Palsy With Scoliosis Treated With and Without Surgery. Neurology. 2023 Oct 31;101(18):e1787-e1792. doi: 10.1212/WNL.0000000000207796. Epub 2023 Sep 7.

  PMID: 37679048 BACKGROUND

Study Officials

• Matti Ahonen, MD, Ass Prof, Ortho surgeon

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilkka Helenius, MD, orthopaedic surgeon

CONTACT

+358443380034; ilkka.helenius@helsinki.fi

Tanja Perokorpi, MSc

CONTACT

+358504286559; tanja.perokorpi@hus.fi

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: A double-blind placebo controlled randomized clinical trial

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 18, 2025
• Study Start: May 2, 2025
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FI (2)