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

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.

Timeline

Start

2025-05-02

Primary completion

2030-12-31

Completion

2030-12-31

Publications

• Background 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

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