Status:
COMPLETED
Effect of Human Thrombin With Gelatin Matrix on Perioperative Blood Loss in Scoliosis Surgery
Lead Sponsor:
Turku University Hospital
Collaborating Sponsors:
Tampere University Hospital
Helsinki University Central Hospital
Conditions:
Adolescent Idiopathic Scoliosis
Eligibility:
All Genders
10-20 years
Phase:
PHASE4
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...
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 t...
Eligibility Criteria
Inclusion
- 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
- Need for anteroposterior surgery
- Need for vertebral column resection
- Smoking
- Diabetes mellitus
- Abnormalities in blood coagulation
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2016
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT01451788
Start Date
November 1 2011
End Date
December 1 2016
Last Update
October 8 2020
Active Locations (3)
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1
Helsinki University Central Hospital
Helsinki, Finland
2
Tampere University Central Hospital
Tampere, Finland
3
Turku Children's Hospital
Turku, Finland, FI-20521