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

NCT ID: NCT01451788

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2016-12-31

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.

Detailed Description

Background: Posterior spinal deformity surgery can be associated with major blood loss, especially from cancellous bone or epidural venous plexus. Products such as Gelatin Matrix with bovine derived thrombin (Floseal) can be used to prevent blood loss in adult patients undergoing spine surgery.

Aim: To document and compare effectiveness of Gelatin matrix with human derived thrombin with conventional blood loss control methods in adolescents undergoing posterior spinal deformity surgery for adolescent idiopathic scoliosis (AIS), who do not need vertebral column resection.

Methods: 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, Tampere 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.

Main outcome measures:

Blood loss during surgery (millilitres) Drain output during 24 hours (millilitres) Total blood loss (Blood loss during surgery + drain output, millitres) Used blood products (Red cell, frozen plasma, and thrombocyte units) Time of surgery Hospital stay Cost benefit analysis (blood product use, surgical time, hospital stay) Complications related to use of Floseal as a secondary outcome measure.

Primary Hypothesis and expected outcomes: Use of Floseal will reduce blood loss and surgical time in patients undergoing spine surgery for adolescent idiopathic scoliosis (Level-I evidence). Cost benefit analysis will most probably show that the use of Floseal is cost effective. E.g. the value of one allogenic Red Blood Cell unit is 400€. If no red blood cell units are needed instead of the usual three, the reduced blood product use alone will cover the extra costs of Floseal use. In addition, if no allogenic blood infusions are needed, the risk of infections will probably be significantly less. Reduced surgical time and shorter hospital stay may also be cost reducing findings in patients receiving Floseal.

Safety Aspects: Gelatin Matrix with human derived thrombin (Floseal, Baxter Biosurgery) is indicated for blood loss control in patients undergoing spine surgery when other methods are less effective.

Conditions

Adolescent Idiopathic Scoliosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Floseal

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

Group Type: EXPERIMENTAL

Gelatin matrix with human derived thrombin (Floseal, Baxter)

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Floseal, Baxter

Eligibility Criteria

Inclusion Criteria

• 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).

Exclusion Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tampere University Hospital

OTHER

Sponsor Role: collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role: collaborator

Turku University Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ilkka J. Helenius, M.D., Ph.D.

Role: STUDY_DIRECTOR

Turku Children's Hospital, Turku University Central Hospital

Locations

Helsinki University Central Hospital

Helsinki, , Finland

Tampere University Central Hospital

Tampere, , Finland

Turku Children's Hospital

Turku, , Finland

Countries

Finland

Other Identifiers

TurkuUH

Identifier Type: -

Identifier Source: org_study_id