Pooled human plasma vs. Crystalloid in the fluid management of children undergoing instrumented spinal fusion for scoliosis. A double-blind, randomized clinical trial.

Start 2 May 2025 · Status Ongoing, recruiting · 1 EU/EEA countries · 2 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic exploratory (Phase II)

Status Ongoing, recruiting

Participants planned 90

Countries 1

Sites 2

Neuromuscular scoliosis (NMS)

To quantify the efficacy of OCTAPLAS infusion to reduce intraoperative blood loss compared with PLASMALYTE in subjects undergoing PSF for scoliosis.

Key facts

Sponsor: HUS-Yhtymae
Participant type: Pediatric, Patients
Age range: 0-17 years, 18-64 years
Gender: Male and Female
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trial duration: 2 May 2025 → ongoing
Decision date (initial): 2024-11-12
Transition trial: No
Low-intervention: No
Rare-disease indication: No
Vulnerable population: Yes

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy

To quantify the efficacy of OCTAPLAS infusion to reduce intraoperative blood loss compared with PLASMALYTE in subjects undergoing PSF for scoliosis.

Conditions and MedDRA coding

Neuromuscular scoliosis (NMS)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 1

Scoliosis patients (aged 10 to 21 years of age) undergoing posterior spinal fusion for adolescent idiopathic scoliosis or neuromuscular scoliosis (>45 degrees) using pedicle screw technique.

Exclusion criteria 1

Coagulation disorder, smoking, unwilling to consent, vertebral column resection, need for anteroposterior surgery and body mass index over 40.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

Primary outcome is the intraoperative blood loss (blood loss in mL after wound closure).

Secondary endpoints 1

Secondary outcomes include need for allogenic red blood cell infusion (percentage of patients at hospital release, health-related quality of life (Scoliosis Research Society 24 outcome questionnaire), postoperative pain (48-hour opioid consumption, pain visual analogue score), operative time (hours), drain output (mL), hidden blood loss (mL), hospital stay, and complications (skin reactions, TRALI, deep surgical site infection).

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

octaplasLG infuusiokuiva-aine ja liuotin, liuosta varten

PRD10335873 · Product

Active substance: Human Plasma Protein
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENOUS INFUSION
Max daily dose: 10 millilitre(s)/kilogram
Max total dose: 10 millilitre(s)/kilogram
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: B05AA — BLOOD SUBSTITUTES AND PLASMA PROTEIN FRACTIONS
Marketing authorisation: 40471
MA holder: OCTAPHARMA AB
MA country: Finland
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Comparator 1

Plasma-Lyte® 148 (pH 7.4) solution for infusion.

PRD332654 · Product

Active substance: Magnesium Chloride Hexahydrate
Pharmaceutical form: SOLUTION FOR INFUSION
Route of administration: INTRAVENIOUS INFUSION
Max daily dose: 10 millilitre(s)/kilogram
Max total dose: 10 millilitre(s)/kilogram
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: B05BB01 — ELECTROLYTES
Marketing authorisation: PL 00116/0332
MA holder: BAXTER HEALTHCARE LTD.
MA country: XI
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

HUS-Yhtymae

Sponsor organisation: HUS-Yhtymae
Address: Stenbackinkatu 9
City: Helsinki
Postcode: 00290
Country: Finland

Scientific contact point

Organisation: HUS-Yhtymae
Contact name: Clinical Trial Unit (CTU)

Public contact point

Organisation: HUS-Yhtymae
Contact name: Clinical Trial Unit (CTU)

Locations

1 EU/EEA country · 2 investigational sites

By country

Country	MS status	Planned subjects	Sites
Finland	Ongoing, recruiting	90	2
Rest of world	—	0	—

Investigational sites

Finland

2 sites · Ongoing, recruiting

Turku University Hospital

Anesthesiology and Intensive Care, Lighthouse Hospital, Kiinamyllynkatu 4-8, 20520, Turku

HUS-Yhtymae

Department of Pediatric Orthopedics and Traumatology, Stenbackinkatu 9, 00290, Helsinki

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Finland	2025-05-02		2025-05-02

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 14 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	D1_Protocol and synopsis_2024-514857-31-00	3.0
Protocol (for publication)	D4_Patient facing documents_pain location drawing FI	1
Protocol (for publication)	D4_Patient facing documents_pain location drawing SVE	1
Protocol (for publication)	D4_Patient facing documents_SRS questionnaire FI	1
Protocol (for publication)	D4_Patient facing documents_SRS questionnaire SVE	1
Recruitment arrangements (for publication)	K1_Recruitment arrangements_Octaplas	2.0
Subject information and informed consent form (for publication)	L1_SIS and ICF_Octaplas_legal representatives of subjects	2
Subject information and informed consent form (for publication)	L1_SIS and ICF_Octaplas_parents of subjects under 18y	3
Subject information and informed consent form (for publication)	L1_SIS and ICF_Octaplas_subjects 10-14y old	2
Subject information and informed consent form (for publication)	L1_SIS and ICF_Octaplas_subjects 15-17y old	2
Subject information and informed consent form (for publication)	L1_SIS and ICF_Octaplas_subjects 18y and older	3
Subject information and informed consent form (for publication)	L1_SIS and ICF_Octaplas_subjects plain language	2
Summary of Product Characteristics (SmPC) (for publication)	G2_SmPC_octaplasLG	3.0
Summary of Product Characteristics (SmPC) (for publication)	G2_SmPC_Plasmalyte	1

Application history

2 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-08-01	Finland	Acceptable with conditions 2024-11-04	2024-11-12
2	SUBSTANTIAL MODIFICATION	SM-3	2024-11-27	Finland	Acceptable 2025-01-16	2025-01-16