Deep Vein ThrombosisPhase 2/3NCT01446887

Prophylactic Anticoagulation for Preventing Deep Vein Thrombosis After Total Hip Arthroplasty

A Phase 2/3 study testing prophylactic anticoagulation in people with Deep Vein Thrombosis, run by JIANG Qing at 1 site in China.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 35 to 90 years
Conditions the study is for: Deep Vein Thrombosis
What is being tested?: prophylactic anticoagulation
Could I receive a placebo?: No, everyone receives an active treatment
How many people: Not given
Where: 1 siteChina
Study dates: Jan 2007to Feb 2011
Phase: Phase 2/3
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 35 to 90 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Primary total hip arthroplasty

Who cannot join

Revision hip replacement, total knee replacement, revision knee replacement, semi-hip replacement and cemented THR were excluded.
Coagulation related disease and cancer were excluded either.

Trial locations and contacts

1 site in 1 country.

China1 site

The Center of Diagnosis and Treatment for Joint Disease, Drum Tower Hospital
Nanjing, Jiangsu, 210008

Other trials in China

About this study

Official title: Phase II Study of Prophylactic Anticoagulation for Preventing Deep Vein Thrombosis After Total Hip Arthroplasty

Deep vein thrombosis (DVT) remains a life-threatening complication of arthroplasty. It remains controversial for anticoagulation strategies after total hip arthroplasty (THA). A randomized double-blind study was conducted to determine whether prophylactic anticoagulation was efficient reduce DVT after THA. subjects who underwent uncemented THA were assigned to prophylactic anticoagulation group or non- prophylactic anticoagulation group. Patients were followed up 3 months later after surgery. DVT was tested by contrast venography. Investigator also used logistic regression analysis with variable selection for obtaining the prediction model of DVT. DVT after THA was affected by personal (age) and clinical factors (mechanical compression, duration of surgery). THA with short duration of surgery did not require prophylactic anticoagulation.

Conditions: Deep Vein Thrombosis
Being tested: prophylactic anticoagulation
Keywords: Deep Vein Thrombosis, total hip arthroplasty, prophylactic anticoagulation, randomized study
Medical subject headings: Venous Thrombosis

What participants receive

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

prophylactic anticoagulationOther
prophylactic anticoagulation by rivaroxaban

Study groups in NCT01446887
Study group	Role	What they receive
non-prophylactic anticoagulation	No intervention	without prophylactic anticoagulation
prophylactic anticoagulation	Experimental	prophylactic anticoagulation by rivaroxaban Receives: Other: prophylactic anticoagulation

What is being measured

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

all cause DVT
deep-vein thrombosis nonfatal pulmonary embolism, or death
Measured: 7 days

Secondary outcomes (1)

Major DVT
major venous thromboembolism (proximal deep-vein thrombosis, nonfatal pulmonary embolism, or death from venous thromboembolism)
Measured: 7 days

Timeline

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

Jan 2007Feb 2011

First posted5 Oct 2011 (estimated)
Study startJan 2007
Primary completionDec 2010
Study completionFeb 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Deep Vein ThrombosisStudies 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 2/3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor

IDs, dates and publications

ClinicalTrials.gov ID: NCT01446887
Sponsor's protocol ID: NJDVTS
Status last verified: Oct 2011
First submitted: 28 Sep 2011
Last updated: 12 Oct 2011
Results posted: No
Data monitoring committee: Yes

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

Recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
Venous Thromboses, Venous Disease
Enrolling by invitationObservational study
ClotTriever® Thrombectomy System Use-Result Survey in Japan
Deep Vein Thrombosis
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
Not yet recruiting
SAFELY RULING OUT DEEP VEIN THROMBOSIS IN PREGNANCY WITH THE LEFt SCORE AND TRIMESTER-ADJUSTED D-DIMER CUTOFFS (the PREG-DVT Study): A PROSPECTIVE COHORT STUDY.
Pregnancy Related, Deep Vein Thrombosis

All Deep Vein Thrombosis trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Study of Prophylactic Anticoagulation for Preventing Deep Vein Thrombosis After Total Hip Arthroplasty
ClinicalTrials.gov ID: NCT01446887
Acronym / sponsor ID: NJDVTS
Conditions: Deep Vein Thrombosis
Keywords: Deep Vein Thrombosis, total hip arthroplasty, prophylactic anticoagulation, randomized study
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Completed
Lead sponsor: JIANG QingUniversity, hospital or other
Study start: Jan 2007
Primary completion: Dec 2010 (actual)
Study completion: Feb 2011 (actual)
First posted: 5 Oct 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.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
non-prophylactic anticoagulation	No intervention	–without prophylactic anticoagulation
prophylactic anticoagulation	Experimental	Other: prophylactic anticoagulationprophylactic anticoagulation by rivaroxaban

Who may qualify

Ages: 35 to 90 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Primary total hip arthroplasty

Key exclusion criteria (2 listed)

Revision hip replacement, total knee replacement, revision knee replacement, semi-hip replacement and cemented THR were excluded.
Coagulation related disease and cancer were excluded either.

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
prophylactic anticoagulationprophylactic anticoagulation by rivaroxaban	Other	prophylactic anticoagulation

Primary outcome

all cause DVT
Time frame: 7 days
deep-vein thrombosis nonfatal pulmonary embolism, or death

1 secondary outcome

Major DVT
Time frame: 7 days

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 12 Oct 2011.

Related trials for Deep Vein Thrombosis

Recruiting
The GORE® VIABAHN® FORTEGRA Venous Stent Post-Approval Study
Venous Thromboses, Venous Disease
Enrolling by invitationObservational study
ClotTriever® Thrombectomy System Use-Result Survey in Japan
Deep Vein Thrombosis
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
Not yet recruiting
SAFELY RULING OUT DEEP VEIN THROMBOSIS IN PREGNANCY WITH THE LEFt SCORE AND TRIMESTER-ADJUSTED D-DIMER CUTOFFS (the PREG-DVT Study): A PROSPECTIVE COHORT STUDY.
Pregnancy Related, Deep Vein Thrombosis

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.

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

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing prophylactic anticoagulation in people with Deep Vein Thrombosis, run by JIANG Qing at 1 site in China.

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 2 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 12 Oct 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 China. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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.

What does the primary outcome measure?

all cause DVT (time frame: 7 days). 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 NCT01446887.

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 12 Oct 2011.