Venous ThrombosisBRiEFNCT00521885
Comparison of Arixtra vs. Lovenox to Prevent Blood Clots in Medically Ill Patients
A study testing Arixtra (Fondaparinox) 2.5 mg SC Daily and Lovenox 40mg SC Daily in people with Venous Thrombosis, run by Lehigh Valley Hospital at 1 site in United States.
Trial summary
A total of 50 patients >40 yrs of age with an expected hospital stay in the Medical Intensive Care or Regional Heart Unit at LVH Muhlenberg of 6 days or longer will be enrolled. The patient and study team will be blinded to which drug they are receiving (either Arixtra or Lovenox). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Venous Thrombosis
- What is being tested?
- Arixtra (Fondaparinox) 2.5 mg SC Daily and Lovenox 40mg SC Daily
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Sep 2009
- Phase
- Interventional
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female > 40 years of age.
- Pt with expected stay in hospital 6 days or >, with expectation to be bedridden for > 4 days.
- Pts admitted to the MICU, Regional Heart Units of LV-MHC
Who cannot join
- Surgical primary admission diagnosis
- Recent surgery within the past 12 weeks
- Planned surgery on the current admission
- Pregnancy
- Vent-dependent respiratory failure requiring intubation for >24 hours.
- Known current DVT or PE prior to enrollment in study.
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- Creatinine clearance < 30 mL/min (calculated by the Cockcroft-Gault method) in a well-hydrated patient.
- Hx of prior or current lower upper or lower GI bleed.
- Platelet count < 100,000 per cubic millimeter
- Current or prior anticoagulation within the prior 48 hours, excluding a single dose \&lor 24 hour period of prophylactic agent
- Bacterial endocarditis.
- Hemophilia
- Hypersensitivity to aspirin.
- Hypersensitivity to Arixtra or Lovenox
- Hx of hemorrhagic or ischemic stroke < 3 months prior to enrolling
- Hematocrit < 28%.
- SBP >200 mmHg or DBP >120 mmHg
- Positive for occult blood in stool.
- Admission to hospital for > 48 hours prior to randomization
- Documented congenital or acquired bleeding disorder
- Indwelling intrathecal or epidural catheter
- Life expectancy < 30 days
- Inability to have a flu assessment post-discharge from the hospital
Trial locations and contacts
1 site in 1 country.
United States1 site
Lehigh Valley Hospital Muhlenberg
Bethlehem, Pennsylvania, 18017
About this study
Official title: Arixtra(Fondaparinux) vs. Lovenox (Enoxaparin) in Prevention of DVT in Acute Medically Ill, Non-surgical Patients
A total of 50 patients >40 yrs of age with an expected hospital stay in the Medical Intensive Care or Regional Heart Unit at LVH Muhlenberg of 6 days or longer will be enrolled. The patient and study team will be blinded to which drug they are receiving (either Arixtra or Lovenox). Subjects will be examined for any bleeding complications. Subjects will receive drug for a total of 6-14 days while in the hospital. A follow up phone call will be performed by the study team approximately 30 days after discharge from the hospital.
Read the detailed description
A total of 50 patients will be enrolled in this double-blinded, randomized, controlled trial. Inclusion criteria: subjects>40 yrs of age with an expected hospital stay in the Medical Intensive Care or Regional Heart Unit at LVH Muhlenberg of 6 days or longer (4 days bedridden) will be enrolled. Total drug treatment will be 6-14 days while in the hospital. A follow up phone call will be performed by the study team approximately 30 days after hospital discharge. Primary endpoint: bleeding rate (minor vs major) between study days 1-14. Secondary endpoint: DVT study days 1-14 (confirmed with LE duplex ultrasonogram).
- Conditions
- Venous Thrombosis
- Being tested
- Arixtra (Fondaparinox) 2.5 mg SC Daily, Lovenox 40mg SC Daily
- Keywords
- Bleeding rates, Prophylaxis for deep vein thrombosis
- Medical subject headings
- Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arixtra (Fondaparinox) 2.5 mg SC DailyDrug
Also called fondaparinux
Patients will be randomized to receive Arixtra 2.5mg once a day if randomized to this arm
Lovenox 40mg SC DailyDrug
Also called enoxaparin
Patients will be randomized to receive Lovenox 40mg SC Daily if randomized to this arm
| Study group | Role | What they receive |
|---|---|---|
| Arixtra (Fondaparinox) 2.5 mg SC Daily | Active comparator | Arixtra (Fondaparinox) 2.5 mg SC Daily Receives: Drug: Arixtra (Fondaparinox) 2.5 mg SC Daily |
| Lovenox 40mg SC Daily | Active comparator | Lovenox 40mg SC Daily Receives: Drug: Lovenox 40mg SC Daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding Rate Study Day 1-14 (Minor vs Major) With 30 Day f/u
Bleeding Rate- Major bleeding defined as one or a combination of the following: Fatal; Bleeding at critical organ sites (intracranial, retroperitoneal, intraocular, pericardial, spinal or adrenal). Minor Bleeding defined as clinically overt bleeding that is not major bleeding.
Measured: 14 days
Secondary outcomes (1)
Deep Vein Thrombosis
Confirmed by Lower Extremity Ultra-sonogram
Measured: 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2007 (estimated)
- Study startSep 2007
- Primary completionSep 2009
- Study completionSep 2009
Why it stopped: Study stopped due to lack of accrual
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 Venous 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lehigh Valley Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Robert Kruklitis, MD, Principal investigator, Lehigh Valley Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00521885
- Sponsor's protocol ID
- LVH IRB# 2-20070508
- Acronym
- BRiEF
- Status last verified
- Nov 2017
- First submitted
- 24 Aug 2007
- Last updated
- 29 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arixtra(Fondaparinux) vs. Lovenox (Enoxaparin) in Prevention of DVT in Acute Medically Ill, Non-surgical Patients
- ClinicalTrials.gov ID
- NCT00521885
- Acronym / sponsor ID
- BRiEF / LVH IRB# 2-20070508
- Conditions
- Venous Thrombosis
- Keywords
- Bleeding rates, Prophylaxis for deep vein thrombosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped due to lack of accrual
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Lehigh Valley HospitalUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Sep 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 28 Aug 2007 (estimated)
- Results
- Posted 1 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A total of 50 patients >40 yrs of age with an expected hospital stay in the Medical Intensive Care or Regional Heart Unit at LVH Muhlenberg of 6 days or longer will be enrolled. The patient and study team will be blinded to which drug they are receiving (either Arixtra or Lovenox). Subjects will be examined for any bleeding complications. Subjects will receive drug for a total of 6-14 days while in the hospital. A follow up phone call will be performed by the study team approximately 30 days after discharge from the hospital.
Detailed description
A total of 50 patients will be enrolled in this double-blinded, randomized, controlled trial. Inclusion criteria: subjects>40 yrs of age with an expected hospital stay in the Medical Intensive Care or Regional Heart Unit at LVH Muhlenberg of 6 days or longer (4 days bedridden) will be enrolled. Total drug treatment will be 6-14 days while in the hospital. A follow up phone call will be performed by the study team approximately 30 days after hospital discharge. Primary endpoint: bleeding rate (minor vs major) between study days 1-14. Secondary endpoint: DVT study days 1-14 (confirmed with LE duplex ultrasonogram).
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 |
|---|---|---|
| Arixtra (Fondaparinox) 2.5 mg SC Daily | Active comparator | Drug: Arixtra (Fondaparinox) 2.5 mg SC DailyArixtra (Fondaparinox) 2.5 mg SC Daily |
| Lovenox 40mg SC Daily | Active comparator | Drug: Lovenox 40mg SC DailyLovenox 40mg SC Daily |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female > 40 years of age.
- Pt with expected stay in hospital 6 days or >, with expectation to be bedridden for > 4 days.
- Pts admitted to the MICU, Regional Heart Units of LV-MHC
Key exclusion criteria (23 listed)
- Surgical primary admission diagnosis
- Recent surgery within the past 12 weeks
- Planned surgery on the current admission
- Pregnancy
- Vent-dependent respiratory failure requiring intubation for >24 hours.
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 (Fondaparinox) 2.5 mg SC DailyAlso: fondaparinuxPatients will be randomized to receive Arixtra 2.5mg once a day if randomized to this arm | Drug | Arixtra (Fondaparinox) 2.5 mg SC Daily |
| Lovenox 40mg SC DailyAlso: enoxaparinPatients will be randomized to receive Lovenox 40mg SC Daily if randomized to this arm | Drug | Lovenox 40mg SC Daily |
Primary outcome
Bleeding Rate Study Day 1-14 (Minor vs Major) With 30 Day f/u
Time frame: 14 days
Bleeding Rate- Major bleeding defined as one or a combination of the following: Fatal; Bleeding at critical organ sites (intracranial, retroperitoneal, intraocular, pericardial, spinal or adrenal). Minor Bleeding defined as clinically overt bleeding that is not major bleeding.
1 secondary outcome
Deep Vein Thrombosis
Time frame: 14 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Robert Kruklitis, MD principal investigator
Lehigh Valley Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arixtra (Fondaparinox) 2.5 mg SC Daily and Lovenox 40mg SC Daily in people with Venous Thrombosis, run by Lehigh Valley Hospital 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 23 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: stopped early, as of the sponsor's last update on 29 Oct 2021. 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?
Yes. Results are posted in the registry (first posted 1 Nov 2017). 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?
Bleeding Rate Study Day 1-14 (Minor vs Major) With 30 Day f/u (time frame: 14 days). 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 29 Oct 2021.