One-stage Bilateral Total Hip ReplacementNCT01468129
Cell Saver Use in Bilateral Total Hip Arthroplasty (THA)
A study testing Cell Saver in people with One-stage Bilateral Total Hip Replacement, run by Rothman Institute Orthopaedics at 1 site in United States.
Trial summary
This study will investigate the efficacy of using cell saver during bilater total hip arthroplasty Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- One-stage Bilateral Total Hip Replacement
- What is being tested?
- Cell Saver
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Dec 2012
- Phase
- Interventional
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is over 21 years of age
- Subject with bilateral degenerative disease of hips who are candidate for one-stage bilateral THA
- Subject willing and able to provide written informed consent
Who cannot join
- Subject with significant comorbidities identified by Charleston index of ≥ 3
- Subject with malignancy
- Subject with history of heart disease, myocardial infarction, pulmonary insufficiency, pulmonary embolus, documented fat emboli syndrome, adult respiratory distress syndrome, documented patent ductus arteriosus or septal defect, chronic renal failure and/or acute hepatic failure or chirhosis
- Subjects with hematologic disorders such as anemia (Hb < 10 g/dL) and sickle cell disease, acquired or congenital coagulopathies, acquired or congenital bleeding disorders,
- Subject who received anticoagulant such as aspirin or Warfarin (Coumadin) or antiplatelet agents such as clopidogrel (Plavix) within 7 days of surgery
- Subject who received hemostatic agents such as tranexamic acid and aprotinin
Show all 12Show fewer
- Subjects utilizing acute normovolumic haemodilution
- Subject is not permitted to remain without his/her anti-coagulant regimen (eg Plavix) for 48 hours postoperatively
- Subject is known to be pregnant.
- Subject has erythropoietin agonist/stimulating agent within 90 days prior to surgery.
- Presence of contaminants such as urine, fat, bowel contents, and most importantly infection in the operative field
- Presence of vasoactive drugs such as papaverine in the operative field
Trial locations and contacts
1 site in 1 country.
Tiffany Morrison, MS contact
United States1 site, 1 recruiting
- Recruiting
Rothman Institute
Philadelphia, Pennsylvania, 19107
Javad Parvizi, MD, FRCS
William Hozack, MD
About this study
Official title: A Prospective, Randomized Controlled Trial to Evaluate the Efficacy of Cell Saver to Redue Blood Loss in One-stage Bilateral Total Hip Arthroplasty (THA)
This study will investigate the efficacy of using cell saver during bilater total hip arthroplasty
- Being tested
- Cell Saver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell SaverOther
| Study group | Role | What they receive |
|---|---|---|
| Cell Saver | Active comparator | Not described Receives: Other: Cell Saver |
| Non Cell Saver | No intervention | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for One-stage Bilateral Total Hip ReplacementStudies 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 N/A
Sponsor and investigators
- Lead sponsor
- Rothman Institute Orthopaedics
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01468129
- Sponsor's protocol ID
- 11UJPAR
- Status last verified
- Nov 2011
- First submitted
- 7 Nov 2011
- Last updated
- 9 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled Trial to Evaluate the Efficacy of Cell Saver to Redue Blood Loss in One-stage Bilateral Total Hip Arthroplasty (THA)
- ClinicalTrials.gov ID
- NCT01468129
- Acronym / sponsor ID
- 11UJPAR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Rothman Institute OrthopaedicsUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2012
- Study completion
- Dec 2012
- First posted
- 9 Nov 2011 (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 study will investigate the efficacy of using cell saver during bilater total hip arthroplasty
Study design
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cell Saver | Active comparator | Other: Cell Saver |
| Non Cell Saver | No intervention | – |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is over 21 years of age
- Subject with bilateral degenerative disease of hips who are candidate for one-stage bilateral THA
- Subject willing and able to provide written informed consent
Key exclusion criteria (12 listed)
- Subject with significant comorbidities identified by Charleston index of ≥ 3
- Subject with malignancy
- Subject with history of heart disease, myocardial infarction, pulmonary insufficiency, pulmonary embolus, documented fat emboli syndrome, adult respiratory distress syndrome, documented patent ductus arteriosus or septal defect, chronic renal failure and/or acute hepatic failure or chirhosis
- Subjects with hematologic disorders such as anemia (Hb < 10 g/dL) and sickle cell disease, acquired or congenital coagulopathies, acquired or congenital bleeding disorders,
- Subject who received anticoagulant such as aspirin or Warfarin (Coumadin) or antiplatelet agents such as clopidogrel (Plavix) within 7 days of surgery
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 |
|---|---|---|
| Cell Saver | Other | Cell Saver |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2011.
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.
Tiffany Morrison, MS contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cell Saver in people with One-stage Bilateral Total Hip Replacement, run by Rothman Institute Orthopaedics at 1 site in United States.
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 3 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 9 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tiffany Morrison, MS (tiffany.morrison@rothmaninstitute.com), or a site near the patient. 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 9 Nov 2011.