Hip Replacement SurgeryPhase 3NCT00161902
Efficacy and Safety of Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D) for Hemostasis in Subjects Undergoing Total Hip Replacement
A Phase 3 study testing Fibrin Sealant Vapor-Heated Solvent/Detergent-treated in people with Hip Replacement Surgery, run by Baxter Healthcare Corporation at 7 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hip Replacement Surgery
- What is being tested?
- Fibrin Sealant Vapor-Heated Solvent/Detergent-treated
- How many people
- Not given
- Where
- 7 sitesin 3 countries
- Study dates
- Aug 2001to Mar 2003
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Subjects fulfilling the following exclusion criteria will not be recruited into the study:
- Impaired coagulation
- Previous hip surgery
- Acetabular roof plastic
- Known hypersensitivity to aprotinin or other components of the product
- Immunodeficiency
Show all 10Show fewer
- Increased red cell production
- Pregnant or lactating women (positive urine or serum pregnancy test; this test is required of any female subject who is not post menopausal or surgically sterilized).
- Subjects concurrently participating in another clinical trial or having received another investigational drug within the last 30 days.
- Also patients with abnormal coagulation values due to anticoagulants like coumadins or heparin must be excluded.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Austria3 sites
A. ö. Krankenhaus Krems, Abteilung f. Orthopädie
Krems, Lower Austria, 3500
Allgemeines Krankenhaus der Stadt Wien, University Clinic for Orthopedics
Vienna, 1090
Donauspital im SMZ Ost, Department of Orthopedic Surgery
Vienna, 1220
Netherlands3 sites
St. Anna Ziekenhuis, Orthopedic Surgery
Geldrop, 5664
Academisch Ziekenhuis Maastricht, Orthopedic Surgery
Maastricht, 6229
St. Clara Ziekenhuis, Orthopedic Surgery
Rotterdam, 3078
Germany1 site
Klinik für Unfall- u. Wiederherstellungschirurgie des Zentralklinikums Augsburg
Augsburg, 86156
About this study
Official title: A Randomized, Controlled, Multicenter Study to Evaluate Efficacy and Safety of Fibrin Sealant VH S/D for Hemostasis in Subjects Undergoing Total Hip Replacement
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.
- Conditions
- Hip Replacement Surgery
- Being tested
- Fibrin Sealant Vapor-Heated Solvent/Detergent-treated
- Keywords
- Arthroplasty, Hip Prosthesis, Cement Free Hip Prosthesis, Femur Head Necrosis, Coxarthrosis
- Medical subject headings
- Femur Head Necrosis, Osteoarthritis, Hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fibrin Sealant Vapor-Heated Solvent/Detergent-treatedDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startAug 2001
- Study completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip Replacement SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Baxter Healthcare Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Florian Gottsauner-Wolf, MD, Principal investigator, A. ö. Krankenhaus Krems, AustriaAxel Rüter, MD, Principal investigator, Klinik für Unfall- und Wiederherstellungschirurgie des Zentralklinikums Augsburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00161902
- Sponsor's protocol ID
- 550001
- Status last verified
- Oct 2006
- First submitted
- 8 Sep 2005
- Last updated
- 23 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled, Multicenter Study to Evaluate Efficacy and Safety of Fibrin Sealant VH S/D for Hemostasis in Subjects Undergoing Total Hip Replacement
- ClinicalTrials.gov ID
- NCT00161902
- Acronym / sponsor ID
- 550001
- Conditions
- Hip Replacement Surgery
- Keywords
- Arthroplasty, Hip Prosthesis, Cement Free Hip Prosthesis, Femur Head Necrosis, Coxarthrosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Baxter Healthcare CorporationIndustry (pharma, biotech, devices)
- Study start
- Aug 2001
- Study completion
- Mar 2003
- First posted
- 13 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- Subjects fulfilling the following exclusion criteria will not be recruited into the study:
- Impaired coagulation
- Previous hip surgery
- Acetabular roof plastic
- Known hypersensitivity to aprotinin or other components of the product
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fibrin Sealant Vapor-Heated Solvent/Detergent-treated | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florian Gottsauner-Wolf, MD principal investigator
A. ö. Krankenhaus Krems, Austria
Axel Rüter, MD principal investigator
Klinik für Unfall- und Wiederherstellungschirurgie des Zentralklinikums Augsburg, Germany
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fibrin Sealant Vapor-Heated Solvent/Detergent-treated in people with Hip Replacement Surgery, run by Baxter Healthcare Corporation at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Austria, Netherlands, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2006.