Primary Total Hip and Knee ArthroplastyPhase 4NCT01809054

Pilot Study Evaluating Alterations in Thrombogenicity and Platelet Reactivity Following Lower Extremity Arthroplasty

A Phase 4 study testing Arixtra, Pneumatic compression stockings and Aspirin in people with Primary Total Hip and Knee Arthroplasty, run by LifeBridge Health at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is a prospective, randomized study from pre-surgery to 6 weeks post-surgery designed to detect changes in coagulability following elective total knee and hip arthroplasty. Patients will be randomized to one of the two standard prophylaxis treatments used at Sinai Hospital: 1. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Primary Total Hip and Knee Arthroplasty
What is being tested?: Arixtra, Pneumatic compression stockings and Aspirin
Type of treatment: Injection or infusion, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 54 participants
Where: 2 sitesUnited States
Study dates: Apr 2012to Feb 2013
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men or women age ≥ 18 years old
Total knee or total hip arthroplasty planned in the 60 days following study enrollment

Who cannot join

Pre-existing anti-coagulant therapy (Heparin, Lovenox, Arixtra, Warfarin, Xarelto, and all other non-mentioned anticoagulants) on admission
History of bleeding diathesis
Known active malignancy
Prothrombin time >1.5 x control
Platelet count < 100,000/mm3, hematocrit < 30%, creatinine clearance <30 mL/min
Immunosuppression, e.g., human immunodeficiency virus (HIV) infection, Chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection, Bacterial endocarditis

Show all 10Show fewer

Major surgery within past 3 months of enrollment
Patients requiring bilateral arthroplasty
Body weight <50 kg (venous thromboembolism prophylaxis only)
Unable to return to site for follow-up visit

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Sinai Center for Thrombosis Research
Baltimore, Maryland, 21215

Other trials in United States

About this study

Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks, or
Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.

Conditions: Primary Total Hip and Knee Arthroplasty
Being tested: Arixtra, Pneumatic compression stockings, Aspirin
Keywords: Hip, Knee, Arthroplasty, venous thromboembolic events, blood loss
Medical subject headings: Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ArixtraDrug
Pneumatic compression stockingsDevice
Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)
AspirinDrug

Study groups in NCT01809054
Study group	Role	What they receive
Arixtra Arm	Active comparator	Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks Receives: Drug: Arixtra; Drug: Aspirin
Pneumatic compression stockings arm	Active comparator	Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks. Receives: Device: Pneumatic compression stockings; Drug: Aspirin

What is being measured

The primary outcome is the main question the study is designed to answer.

Blood Loss
requiring transfusion
Measured: 6 weeks

Secondary outcomes (1)

Deep Vein Thrombosis
verified by ultrasound
Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2012Feb 2013

First posted12 Mar 2013 (estimated)
Study startApr 2012
Primary completionFeb 2013
Study completionFeb 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Primary Total Hip and Knee ArthroplastyStudies 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 54 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01809054
Sponsor's protocol ID: 1888
Status last verified: Mar 2014
First submitted: 8 Mar 2013
Last updated: 21 Apr 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationPhase 4
Efficacy And Safety Of Tramadol And Oxycodone Versus Oxycodone Monotherapy For Pain Control After Primary Total Knee And Total Hip Arthroplasty
Post Operative Pain
RecruitingObservational study
Molecular Mechanisms Underlying Hip and Knee Osteoarthritis in Patients Undergoing Primary Elective Arthroplasty
Total Hip Arthroplasty (THA), Total Knee Arthroplasty (TKA)
Not yet recruitingPhase 4
General Anaesthesia vs Spinal Anaesthesia: Patient Outcomes and Success in Outpatient Primary Total Knee and Hip Arthroplasty
Osteo Arthritis Knee and Hip, Osteo Arthritis
Enrolling by invitationObservational study
Infection-related Revision Rates After Single-dose Versus Multiple-dose Antibiotic Prophylaxis in Primary Hip and Knee Arthroplasty: a Comparative Implementation Study.
Total Hip Arthroplasty (THA), Antibiotic Prophylaxis

All Primary Total Hip and Knee Arthroplasty trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study Evaluating Alterations in Thrombogenicity and Platelet Reactivity Following Lower Extremity Arthroplasty
ClinicalTrials.gov ID: NCT01809054
Acronym / sponsor ID: 1888
Conditions: Primary Total Hip and Knee Arthroplasty
Keywords: Hip, Knee, Arthroplasty, venous thromboembolic events, blood loss
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 54 participants (actual)
Lead sponsor: LifeBridge HealthUniversity, hospital or other
Collaborators: Haemonetics Corporation
Study start: Apr 2012
Primary completion: Feb 2013 (actual)
Study completion: Feb 2013 (actual)
First posted: 12 Mar 2013 (estimated)
Results: Posted 21 Apr 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Arixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks, or
Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Arixtra Arm	Active comparator	Drug: Arixtra, Drug: AspirinArixtra (2.5 mg SQ/QD) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks
Pneumatic compression stockings arm	Active comparator	Device: Pneumatic compression stockings, Drug: AspirinPneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel) for 2 weeks with concomitant Aspirin 325 mg daily for 5 weeks.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Men or women age ≥ 18 years old
Total knee or total hip arthroplasty planned in the 60 days following study enrollment

Key exclusion criteria (10 listed)

Pre-existing anti-coagulant therapy (Heparin, Lovenox, Arixtra, Warfarin, Xarelto, and all other non-mentioned anticoagulants) on admission
History of bleeding diathesis
Known active malignancy
Prothrombin time >1.5 x control
Platelet count < 100,000/mm3, hematocrit < 30%, creatinine clearance <30 mL/min

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
Arixtra	Drug	Arixtra Arm
Pneumatic compression stockingsPneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)	Device	Pneumatic compression stockings arm
Aspirin	Drug	Arixtra Arm, Pneumatic compression stockings arm

Primary outcome

Blood Loss
Time frame: 6 weeks
requiring transfusion

1 secondary outcome

Deep Vein Thrombosis
Time frame: 6 weeks

Results and safety

Results posted to the registry on 21 Apr 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arixtra Arm	27	27
Pneumatic Compression Stockings Arm	22	22

Primary outcome: Blood Loss

Time frame: 6 weeks. Number. Unit: participants

Measure	Arixtra Arm n = 27	Pneumatic Compression Stockings Arm n = 22
Value	6	1

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arixtra Arm	0 of 0	0 of 0	Not reported
Pneumatic Compression Stockings Arm	0 of 0	0 of 0	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Primary Total Hip and Knee Arthroplasty

Enrolling by invitationPhase 4
Efficacy And Safety Of Tramadol And Oxycodone Versus Oxycodone Monotherapy For Pain Control After Primary Total Knee And Total Hip Arthroplasty
Post Operative Pain
RecruitingObservational study
Molecular Mechanisms Underlying Hip and Knee Osteoarthritis in Patients Undergoing Primary Elective Arthroplasty
Total Hip Arthroplasty (THA), Total Knee Arthroplasty (TKA)
Not yet recruitingPhase 4
General Anaesthesia vs Spinal Anaesthesia: Patient Outcomes and Success in Outpatient Primary Total Knee and Hip Arthroplasty
Osteo Arthritis Knee and Hip, Osteo Arthritis
Enrolling by invitationObservational study
Infection-related Revision Rates After Single-dose Versus Multiple-dose Antibiotic Prophylaxis in Primary Hip and Knee Arthroplasty: a Comparative Implementation Study.
Total Hip Arthroplasty (THA), Antibiotic Prophylaxis

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.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Arixtra, Pneumatic compression stockings and Aspirin in people with Primary Total Hip and Knee Arthroplasty, run by LifeBridge Health at 2 sites 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 2 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 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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.

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?

Yes. Results are posted in the registry (first posted 21 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Blood Loss (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01809054.

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 21 Apr 2014.