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

NCT01451788 | Completed Phase 4

• 1 other identifier: TurkuUH
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

RCT; Gelatin matrix; thrombin; idiopathic scoliosis; Surgery

Outcome Measures

Primary Outcomes (1)

• Total perioperative blood loss

  Total blood loss during surgery + drain output, millilitres

  Surgery time (up to 8 hours) + first postoperative 24 hours

Secondary Outcomes (3)

• Used blood products

  Surgery time (up to 8 hours) + first 24 hours postoperatively

• Blood loss during surgery

  up to 8 hours

• Time of surgery

  up to 8 hours

Study Arms (2)

Conventional group

NO INTERVENTION

conventional blood saving methods (use of bone wax for cancellous bony bleeding; bipolar diathermy and epidural space packing for epidural venous bleeding)

Floseal

EXPERIMENTAL

Gelatin matrix with human derived thrombin (Floseal) used in adolescents undergoing posterior spinal deformity surgery for adolescent idiopathic scoliosis (AIS)

Device: Gelatin matrix with human derived thrombin (Floseal, Baxter)

Interventions

Gelatin matrix with human derived thrombin (Floseal, Baxter) DEVICE

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.

Also known as: Floseal, Baxter

Floseal

Eligibility Criteria

• Age: 10 Years - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients will be included if between 10 and 20 years of age, no contraindication for Floseal use, posterior scoliosis surgery using total pedicle screw technique for AIS with normal blood coagulation and normal whole spine magnetic resonance images except spinal deformity (AIS).

You may not qualify if:

• Need for anteroposterior surgery
• Need for vertebral column resection
• Smoking
• Diabetes mellitus
• Abnormalities in blood coagulation

Sponsors & Collaborators

• Turku University Hospital: lead
• Tampere University Hospital: collaborator
• Helsinki University Central Hospital: collaborator

Study Sites (3)

Helsinki University Central Hospital

Helsinki, Finland

Location

Tampere University Central Hospital

Tampere, Finland

Location

Turku Children's Hospital

Turku, FI-20521, Finland

Location

Study Officials

• Ilkka J. Helenius, M.D., Ph.D.

  Turku Children's Hospital, Turku University Central Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2011
• First Posted: October 14, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2016
• Last Updated: October 8, 2020

Record last verified: 2020-10

Locations

FI (3)