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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2011 by Turku University Hospital
Sponsor:
Collaborators:
Tampere University Hospital
Helsinki University Central Hospital
Information provided by (Responsible Party):
Turku University Hospital
ClinicalTrials.gov Identifier:
NCT01451788
First received: September 30, 2011
Last updated: December 13, 2011
Last verified: September 2011
  Purpose

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.


Condition Intervention Phase
Adolescent Idiopathic Scoliosis
Device: Gelatin matrix with human derived thrombin (Floseal, Baxter)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Turku University Hospital:

Primary Outcome Measures:
  • Total perioperative blood loss [ Time Frame: Surgery time (up to 8 hours) + first postoperative 24 hours ] [ Designated as safety issue: Yes ]
    Total blood loss during surgery + drain output, millilitres


Secondary Outcome Measures:
  • Used blood products [ Time Frame: Surgery time (up to 8 hours) + first 24 hours postoperatively ] [ Designated as safety issue: Yes ]
    Red cell, frozen plasma, and thrombocyte units

  • Blood loss during surgery [ Time Frame: up to 8 hours ] [ Designated as safety issue: Yes ]
    Blood loss during primary surgery, in millilitres

  • Time of surgery [ Time Frame: up to 8 hours ] [ Designated as safety issue: No ]
    Time of surgery (hours, minutes)


Estimated Enrollment: 60
Study Start Date: November 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Conventional group
conventional blood saving methods (use of bone wax for cancellous bony bleeding; bipolar diathermy and epidural space packing for epidural venous bleeding)
Experimental: Floseal
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)
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 Name: Floseal, Baxter

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.

  Eligibility

Ages Eligible for Study:   10 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01451788

Contacts
Contact: Ilkka J. Helenius, M.D., Ph.D. +358-2-3130218 ilkka.helenius@tyks.fi
Contact: Olli T. Pajulo, M.D., Ph.D. +358-2-3130000 olli.pajulo@utu.fi

Locations
Finland
Helsinki University Central Hospital Recruiting
Helsinki, Finland
Contact: Mikko Mattila, MD    +358-9-4711    mikko.mattila@hus.fi   
Principal Investigator: Mikko Mattila, MD         
Tampere University Central Hospital Recruiting
Tampere, Finland
Contact: Jarmo Valipakka, MD       jarmo.valipakka@pshp.fi   
Contact: Tuija Lahdes-Vasama, MD, PhD       tuija.lahdesvasama@phsp.fi   
Principal Investigator: Jarmo Valipakka, MD         
Turku Children's Hospital Recruiting
Turku, Finland, FI-20521
Contact: Ilkka J. Helenius, MD, PhD    +358-2-3130218    ilkka.helenius@tyks.fi   
Contact: Olli T. Pajulo, MD, PhD    +358-2+3130000    olli.pajulo@utu.fi   
Sub-Investigator: Olli Pajulo, MD, PhD         
Principal Investigator: Ilkka Helenius, MD, PhD         
Sponsors and Collaborators
Turku University Hospital
Tampere University Hospital
Helsinki University Central Hospital
Investigators
Study Director: Ilkka J. Helenius, M.D., Ph.D. Turku Children's Hospital, Turku University Central Hospital
  More Information

No publications provided

Responsible Party: Turku University Hospital
ClinicalTrials.gov Identifier: NCT01451788     History of Changes
Other Study ID Numbers: TurkuUH
Study First Received: September 30, 2011
Last Updated: December 13, 2011
Health Authority: Finland: Ethics Committee

Keywords provided by Turku University Hospital:
RCT
Gelatin matrix
thrombin
idiopathic scoliosis
Surgery

Additional relevant MeSH terms:
Scoliosis
Blood Loss, Surgical
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Hemorrhage
Pathologic Processes
Intraoperative Complications
Thrombin
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014