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Effect of Human Thrombin With Gelatin Matrix on Perioperative Blood Loss in Scoliosis Surgery

NCT01451788 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2020-10-08

No results posted yet for this study

Summary

The Finnish Paediatric Orthopaedic Study Group will perform a prospective randomized, multicenter, clinical trial comparing Gelatin matrix with human derived thrombin (Floseal, Baxter) and without use of Floseal in adolescents undergoing posterior spinal deformity surgery for AIS (adolescent idiopathic scoliosis between 45 and 90 degrees) in Turku, Tampare and Helsinki Children's Hospitals. Sixty patients will be randomized into the intervention group receiving Floseal (n=30) and control group not receiving Floseal (n=30). Each University Hospital will treat 10 Floseal and 10 conventional treated scoliosis patients (block randomization). Both treatment groups will be allowed to use conventional blood saving methods.

Conditions

  • Adolescent Idiopathic Scoliosis

Interventions

DEVICE

Gelatin matrix with human derived thrombin (Floseal, Baxter)

Floseal will be used to stop cancellous bone bleeding, pedicle channel bleeding or epidural space bleeding by injecting suitable amount of this matrix and irrigating it away after few minutes.

Sponsors & Collaborators

  • Tampere University Hospital

    collaborator OTHER

  • Helsinki University Central Hospital

    collaborator OTHER

  • Turku University Hospital

    lead OTHER_GOV

Principal Investigators

  • Ilkka J. Helenius, M.D., Ph.D. · Turku Children's Hospital, Turku University Central Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
10 Years
Max Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2014-12-31
Completion
2016-12-31

Countries

  • Finland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01451788 on ClinicalTrials.gov