Osteoarthritis, HipPhase 4NCT02379663
Prophylaxis of Deep Vein Thrombosis Following Total Hip Arthroplasty
A Phase 4 study testing Rivaroxaban, Enoxaparin and Normal saline in people with Osteoarthritis, Hip and Femur Head Necrosis, run by Samsung Medical Center.
Trial summary
This prospective study compares an oral direct factor Xa inhibitor with LMWH for thromboprophylaxis in the patients undergoing THA. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Hip, Femur Head Necrosis, Femoral Neck Fractures
- What is being tested?
- Rivaroxaban, Enoxaparin and Normal saline
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 639 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Jan 2013
- Phase
- Phase 4
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female without childbearing potential aged ≥20 years who were scheduled for elective primary THA
Who cannot join
- recent history of active bleeding or VTE
- known genetic disorder associated with bleeding tendency or any condition related with an increased risk of bleeding
- persistent blood pressure of ≥160mmHg systolic and/or ≥100 mmHg diastolic at baseline
- myocardial infarction or cerebrovascular accident within three months of the scheduled surgery
- major surgery in the prior three months
- renal insufficiency with a creatinine clearance <60mL/min , hepatic failure combined with coagulopathy, or thrombocytopenia (platelets < 100,000/mm³), or planned indwelling epidural catheter for > 6 hours after the end of surgery
About this study
Official title: Efficacy and Safety for Prophylaxis of Deep Vein Thrombosis Following Total Hip Arthroplasty
This prospective study compares an oral direct factor Xa inhibitor with LMWH for thromboprophylaxis in the patients undergoing THA.
- Being tested
- Rivaroxaban, Enoxaparin, Normal saline
- Medical subject headings
- Osteoarthritis, Hip, Femur Head Necrosis, Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivaroxabanDrug
Rivaroxaban was taken orally in a dosage of 10mg once daily
EnoxaparinDrug
Enoxaparin was injected subcutaneously in a dosage of 40mg once daily
Normal salineOther
subcutaneous injection of 1 cc of normal saline once daily
| Study group | Role | What they receive |
|---|---|---|
| Oral direct Factor Xa inhibitor | Active comparator | Rivaroxaban Receives: Drug: Rivaroxaban |
| Low molecular weight heparin | Active comparator | Enoxaparin Receives: Drug: Enoxaparin |
| Normal Saline | Placebo comparator | Normal Saline Receives: Other: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major wound complication
hematoma : size, site woozing : frequency, amount, dressing change count infection : culture
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2015 (estimated)
- Study startJan 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, HipStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 639 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02379663
- Sponsor's protocol ID
- 2011-11-012
- Status last verified
- Dec 2014
- First submitted
- 13 Feb 2015
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety for Prophylaxis of Deep Vein Thrombosis Following Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT02379663
- Acronym / sponsor ID
- 2011-11-012
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 639 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 5 Mar 2015 (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.
This prospective study compares an oral direct factor Xa inhibitor with LMWH for thromboprophylaxis in the patients undergoing THA.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral direct Factor Xa inhibitor | Active comparator | Drug: RivaroxabanRivaroxaban |
| Low molecular weight heparin | Active comparator | Drug: EnoxaparinEnoxaparin |
| Normal Saline | Placebo comparator | Other: Normal salineNormal Saline |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male or female without childbearing potential aged ≥20 years who were scheduled for elective primary THA
Key exclusion criteria (6 listed)
- recent history of active bleeding or VTE
- known genetic disorder associated with bleeding tendency or any condition related with an increased risk of bleeding
- persistent blood pressure of ≥160mmHg systolic and/or ≥100 mmHg diastolic at baseline
- myocardial infarction or cerebrovascular accident within three months of the scheduled surgery
- major surgery in the prior three months
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 |
|---|---|---|
| RivaroxabanRivaroxaban was taken orally in a dosage of 10mg once daily | Drug | Oral direct Factor Xa inhibitor |
| EnoxaparinEnoxaparin was injected subcutaneously in a dosage of 40mg once daily | Drug | Low molecular weight heparin |
| Normal salinesubcutaneous injection of 1 cc of normal saline once daily | Other | Normal Saline |
Primary outcome
Major wound complication
Time frame: 2 weeks
hematoma : size, site woozing : frequency, amount, dressing change count infection : culture
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 5 Mar 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rivaroxaban, Enoxaparin and Normal saline in people with Osteoarthritis, Hip and Femur Head Necrosis, run by Samsung Medical Center.
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 1 inclusion and 6 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 5 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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.
What does the primary outcome measure?
Major wound complication (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
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 5 Mar 2015.