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

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-514857-31-00
Enrollment
90
Registered
2024-11-12
Start date
2025-05-02
Completion date
Unknown
Last updated
2025-01-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromuscular scoliosis (NMS), Adolescent idiopathic scoliosis (AIS)

Brief summary

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

Detailed description

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).

Interventions

DRUGPlasma-Lyte® 148 (pH 7.4) solution for infusion.
DRUGoctaplasLG infuusiokuiva-aine ja liuotin

Sponsors

HUS-Yhtymae
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Primary

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

Secondary

MeasureTime frame
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).

Countries

Finland

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026