Venous ThromboembolismPhase 3NCT00493896
Safety of Fondaparinux as Routine VTE Prophylaxis in Medical ICU Patients
A Phase 3 study testing Fondaparinux and Enoxaparin in people with Venous Thromboembolism, run by Eastern Virginia Medical School.
Trial summary
This is a pilot study to evaluate safety of fondaparinux and enoxaparin in terms of bleeding and development of thrombocytopenia in the medical ICU population. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Venous Thromboembolism
- What is being tested?
- Fondaparinux and Enoxaparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- No sites listed yet
- Study dates
- Jul 2007to Apr 2010
- Phase
- Phase 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 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ability or legally authorized representative (LAR) to provide informed consent
- Adult who has not had surgery within 10 days, admitted to the Sentara Norfolk General Hospital ICU Medical Teaching Services for any reason.
Who cannot join
- Active or suspected bleeding
- Platelet count less than 100,000 per microliter (mm3) of blood
- Thrombolytic or anticoagulant treatment (including any doses of prophylactic UFH, LMWH or fondaparinux) during the current hospitalization
- Initial estimated CLcr < 30 ml/min as determined by the Cockcroft-Gault equation
- Initial labs indicative or suggestive of rapidly rising serum Creatinine (>1 mg/dL/day)
- Pregnancy (for medicolegal considerations)
- Patients with or expecting to require an epidural catheter
- Patients who are expected to have an immediate (within 24h) need for surgery
About this study
Official title: Safety of Fondaparinux as Routine VTE Prophylaxis in Medical ICU Patients: An Investigator Initiated Protocol
This is a pilot study to evaluate safety of fondaparinux and enoxaparin in terms of bleeding and development of thrombocytopenia in the medical ICU population.
Read the detailed description
This is a pilot study to evaluate safety of fondaparinux and enoxaparin in terms of bleeding and development of thrombocytopenia in the medical ICU population. We expect the null hypothesis to be proven true. One hundred subjects will be enrolled in this prospective, randomized, double-blind (concealed allocation) pilot study of consecutive medical ICU patients to one of two pharmacologic VTE prophylaxix treatment arms. (1) Primary endpoints include hemoglobin, hematocrit, \& platelet counts. blood product utilization, bleeding complications (any), Steady State Functional Factor Xa activity (for post hoc analysis), non-study pharmacologic VTE prophylaxis (when estimated CLcr < 30ml/min), and days not treated with study drug or treated with alternative agent Secondary/ Additional Data to be collected include patient demographics, primary \& secondary diagnoses, central venous access, and sequential compression device utilization.
- Conditions
- Venous Thromboembolism
- Being tested
- Fondaparinux, Enoxaparin
- Keywords
- Venous Thromboembolism Prophylaxis, VTE prophylaxis
- Medical subject headings
- Venous Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FondaparinuxDrug
Also called Arixtra
The dose for Arixtra is 2.5 mg once daily, subcutaneously.
EnoxaparinDrug
Also called Lovenox
The dose for Lovenox is 40 mg once daily, subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Fondaparinux | Experimental | Fondaparinux treatment - one standard of care option Receives: Drug: Fondaparinux |
| 2 | Active comparator | Enoxaparin Receives: Drug: Enoxaparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bleeding events
Measured: inpatient hospitalization
Secondary outcomes (1)
Development of thrombocytopenia
Measured: inpatient hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2007 (estimated)
- Study startJul 2007
- Primary completionApr 2010
- Study completionApr 2010
Why it stopped: low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eastern Virginia Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Charles W Callender, MD, Principal investigator, Eastern VA Medical School, Norfolk, VA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00493896
- Sponsor's protocol ID
- 107696
- Status last verified
- Apr 2022
- First submitted
- 27 Jun 2007
- Last updated
- 11 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety of Fondaparinux as Routine VTE Prophylaxis in Medical ICU Patients: An Investigator Initiated Protocol
- ClinicalTrials.gov ID
- NCT00493896
- Acronym / sponsor ID
- 107696
- Conditions
- Venous Thromboembolism
- Keywords
- Venous Thromboembolism Prophylaxis, VTE prophylaxis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low enrollment
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Eastern Virginia Medical SchoolUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jul 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 28 Jun 2007 (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 is a pilot study to evaluate safety of fondaparinux and enoxaparin in terms of bleeding and development of thrombocytopenia in the medical ICU population.
Detailed description
This is a pilot study to evaluate safety of fondaparinux and enoxaparin in terms of bleeding and development of thrombocytopenia in the medical ICU population. We expect the null hypothesis to be proven true. One hundred subjects will be enrolled in this prospective, randomized, double-blind (concealed allocation) pilot study of consecutive medical ICU patients to one of two pharmacologic VTE prophylaxix treatment arms. (1) Primary endpoints include hemoglobin, hematocrit, \& platelet counts. blood product utilization, bleeding complications (any), Steady State Functional Factor Xa activity (for post hoc analysis), non-study pharmacologic VTE prophylaxis (when estimated CLcr < 30ml/min), and days not treated with study drug or treated with alternative agent Secondary/ Additional Data to be collected include patient demographics, primary \& secondary diagnoses, central venous access, and sequential compression device utilization.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fondaparinux | Experimental | Drug: FondaparinuxFondaparinux treatment - one standard of care option |
| 2 | Active comparator | Drug: EnoxaparinEnoxaparin |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ability or legally authorized representative (LAR) to provide informed consent
- Adult who has not had surgery within 10 days, admitted to the Sentara Norfolk General Hospital ICU Medical Teaching Services for any reason.
Key exclusion criteria (8 listed)
- Active or suspected bleeding
- Platelet count less than 100,000 per microliter (mm3) of blood
- Thrombolytic or anticoagulant treatment (including any doses of prophylactic UFH, LMWH or fondaparinux) during the current hospitalization
- Initial estimated CLcr < 30 ml/min as determined by the Cockcroft-Gault equation
- Initial labs indicative or suggestive of rapidly rising serum Creatinine (>1 mg/dL/day)
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 |
|---|---|---|
| FondaparinuxAlso: ArixtraThe dose for Arixtra is 2.5 mg once daily, subcutaneously. | Drug | Fondaparinux |
| EnoxaparinAlso: LovenoxThe dose for Lovenox is 40 mg once daily, subcutaneously. | Drug | 2 |
Primary outcome
Bleeding events
Time frame: inpatient hospitalization
1 secondary outcome
Development of thrombocytopenia
Time frame: inpatient hospitalization
Results and safety
The study was stopped early (reason given: low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2022.
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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.
Charles W Callender, MD principal investigator
Eastern VA Medical School, Norfolk, VA
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fondaparinux and Enoxaparin in people with Venous Thromboembolism, run by Eastern Virginia Medical School.
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 8 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 11 Apr 2022. 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. 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 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 was stopped early (reason given: low enrollment). Results are not available in the source record.
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 events (time frame: inpatient hospitalization). 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 11 Apr 2022.