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

Adolescent Idiopathic Scoliosis Clinical Trial

Official title:

Effectiveness Of Gelatin Matrix With Human Derived Thrombin On Blood Loss, Surgical Time, Hospital Stay And Complications In Adolescents Undergoing Spine Surgery For Adolescent Idiopathic Scoliosis: A Randomized Clinical Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01451788
• Other study ID #: TurkuUH
• Status: Completed
• Phase: Phase 4
• Start date: November 2011
• Est. completion date: December 2016

Study information

• Verified date: October 2020
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Intervention

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.

Locations

Country	Name	City	State
Finland	Helsinki University Central Hospital	Helsinki
Finland	Tampere University Central Hospital	Tampere
Finland	Turku Children's Hospital	Turku

Sponsors (3)

Lead Sponsor	Collaborator
Turku University Hospital	Helsinki University Central Hospital, Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total perioperative blood loss	Total blood loss during surgery + drain output, millilitres	Surgery time (up to 8 hours) + first postoperative 24 hours
Secondary	Used blood products	Red cell, frozen plasma, and thrombocyte units	Surgery time (up to 8 hours) + first 24 hours postoperatively
Secondary	Blood loss during surgery	Blood loss during primary surgery, in millilitres	up to 8 hours
Secondary	Time of surgery	Time of surgery (hours, minutes)	up to 8 hours