Efficacy and Safety of Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D) for Hemostasis in Subjects Undergoing Total Hip Replacement

A Randomized, Controlled, Multicenter Study to Evaluate Efficacy and Safety of Fibrin Sealant VH S/D for Hemostasis in Subjects Undergoing Total Hip Replacement

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00161902

Enrollment

Unknown

Registered

2005-09-13

Start date

2001-08-31

Completion date

2003-03-31

Last updated

2006-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Replacement Surgery

Keywords

Arthroplasty, Hip Prosthesis, Cement Free Hip Prosthesis, Femur Head Necrosis, Coxarthrosis

Brief summary

The purpose of the study is to monitor the safety of FS VH S/D and evaluate whether FS VH S/D is superior to standard treatment in reducing blood loss in subjects undergoing total hip replacement with cement-free hip prostheses.

Interventions

DRUGFibrin Sealant Vapor-Heated Solvent/Detergent-treated

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Inclusion criteria

Each subject to be included into the study must fulfill the following inclusion criteria: * Subjects receiving a cement free hip prosthesis due to coxarthrosis because of primary or dysplastic arthrosis grade 1 - 3 according to Crowe or rheumatoid arthritis as well as subjects receiving a cement free hip prosthesis due to femur head necrosis (Crowe classification). * ASA and NSAIDs have been discontinued one week prior to surgery * Written informed consent * Male and female at least 19 years of age

Exclusion criteria

Subjects fulfilling the following

Countries

Austria, Germany, Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026