Pooled Human Plasma vs Crystalloid in The Management of Children Undergoing Instrumented Spinal Fusion for Scoliosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age10-21
SponsorTurku University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
Immunoglobulin A-deficiency
Need for anteroposterior surgery
Need for three column vertebral resection
Smoking
Trial design
Design model
Parallel
Treatments tested in this trial
Pooled human plasma
DrugInfusion of pooled human plasma (Octaplas, 10 mL/kg, max 400 mL) over 1 hour after induction of general anaesthesia
Placebo
DrugInfusion of cryst (Octaplas, 10 mL/kg, max 400 mL) over 1 hour after induction of general anaesthesia
Treatment groups
194 Participants
are divided into 2 treatment groupsGroup A: Pooled human plasmaActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
Exposure to closureSecondary outcomes
1
Total blood loss
Intraoperative and drain output calculated together in milliliters (mL). Mean 24 hour drain output typically equals to intraoperative blood loss with a range from 500 mL to 1500 mL. Higher blood loss during perioperative management is associated with worse outcomes.
Time frame
From exposure to drain removal at 24 hours postoperatively2
Need for allogeneic blood transfusion
Number of red blood cell packages infused during and after surgery until 3rd postoperative day. Use of allogeneic blood transfusion is associated with increased risk for surgical site infection and transfusion related reaction.
Time frame
From surgical exposure to 72 hours postoperatively3
Health-related quality of life
SRS-24 outcome questionnaire total score with 5.0 representing excellent and 1.0 the worse possible scoliosis specific health-related quality of life.
Time frame
At 6 and 24 months4
Adverse events
Deep surgical site infection, skin reaction, transfusion related reaction, neurologic injury. Surgical site infection has an incidence of less than 2.0% after spinal fusion surgery and is associated with significant treatment related burden, including revision surgery and prolonged antibiotic therapy.
Time frame
From surgery to 2-year follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Turku University Hospital
Lead sponsor
Helsinki University Central Hospital
Collaborator
Source ClinicalTrials.gov