Effect of Human Thrombin With Gelatin Matrix on Perioperative Blood Loss in Scoliosis Surgery
Condition: Adolescent Idiopathic Scoliosis
MeSH terms: Scoliosis
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Gelatin matrix with human derived thrombin (Floseal, Baxter)
Intervention type(s): Device
Intervention description(s): 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.
Other intervention name(s): Floseal, Baxter
Intervention MeSH terms: Thrombin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: RCT; Gelatin matrix; thrombin; idiopathic scoliosis; Surgery