Medical PatientPhase 4FAITHNCT01727401
Thromboprophylaxis of Venous Thromboembolism in Acutely-ill Medical Inpatients With Thrombocytopenia
A Phase 4 study testing Fondaparinux in people with Medical Patient and Thrombocytopenia, run by G. d'Annunzio University at 1 site in Italy.
Trial summary
Fondaparinux is a parenteral anticoagulant drug approved for the prophylaxis of venous thromboembolism in high risk medical patients. A relevant proportion of these patients have renal insufficiency and/or thrombocytopenia which represent independent risk factors for bleeding. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medical Patient, Thrombocytopenia
- What is being tested?
- Fondaparinux
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2012to Jul 2021
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age above 18 years;
- hospitalization in an Internal Medicine Unit and a Barbar score of 4 points or above
- Platelet count between 100,000/uL and 30,000/uL
- written informed consent
Who cannot join
- Active bleeding or bleeding within the previous 3 months;
- Known bleeding diathesis;
- Active gastroduodenal ulcer;
- Severe renal insufficiency defined by a creatinine clearance below 20 mL/min;
- Ongoing treatment with unfractionated heparin, low-moleculr-weight heparin, fondaparinux, or oral anticoagulants Trattamento in corso con eparina non
- Prophylaxis with unfractionated heparin, low-moleculr-weight heparin, or fondaparinux for more than 48 hours;
Show all 12Show fewer
- double antiplatelet therapy or acetylsalicylic acid at daily doses above 165 mg;
- planned invasive procedure during the period of thromboprophylaxis;
- Hemoglobin values below 9 g/dL;
- AST or ALT above 2 times the uper limit of normal;
- pregnancy or breast feeding;
- life expectancy lower than 1 month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Thromboprophylaxis With Fondaparinux of Deep Vein Thrombosis and Pulmonary Embolism in the Acutely-ill Medical Inpatients With Thrombocytopenia
Fondaparinux is a parenteral anticoagulant drug approved for the prophylaxis of venous thromboembolism in high risk medical patients. A relevant proportion of these patients have renal insufficiency and/or thrombocytopenia which represent independent risk factors for bleeding. The risk of bleeding may be increased when fondaparinux is administered to patients with a reduced renal function and/or low platelet count. A lower dose of fondaparinux, 1.5 mg daily, has been approved for patients with renal insufficiency defined by a creatinine clearance between 20 and 50 mL/min. However, to our knowledge, there are no clinical studies that have specifically evaluated prophylaxis with fondaparinux in acutely-ill medical patients with a moderate to severe thrombocytopenia. The scope of this study is to evaluate the safety of fondaparinux in high risk hospitalized medical patients with a moderate to severe thrombocytopeniada defined by a platelet count between 100,000/uL and 30,000/uL.
- Conditions
- Medical Patient, Thrombocytopenia
- Being tested
- Fondaparinux
- Keywords
- Fondaparinux, medical patient, vein thromboembolism, prophylaxis, thrombocytopenia
- Medical subject headings
- Thrombocytopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FondaparinuxDrug
Also called Arixtra
Fondaparinux once daily sc injections at a dose of 2.5 mg if renal clearance of creatinine above 50 ml/min or Fondaparinux once daily sc injections 1.5 mg if renal clearance of creatinine between 20 and 50 ml/min
| Study group | Role | What they receive |
|---|---|---|
| Fondaparinux | Experimental | Drug: fondaparinux once daily sc injections 2.5 mg if renal clearance of creatinine above 50 ml/min once daily sc injections 1.5 mg if renal clearance of creatinine between 20 and 50 ml/min Receives: Drug: Fondaparinux |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major bleeding
Major bleeding will be defined as overt bleeding associated with: a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or whole blood, or bleeding that occurs in a critical site: intracranial, intra-spinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal or contributing to death.
Measured: Participants will be followed for the duration of hospital stay up to two days following hospital discharge, an expected average of 2 weeks
Secondary outcomes (3)
Clinically relevant non-major bleeding
clinically relevant non-major bleeding will be defined as overt bleeding not meeting the criteria for major bleeding but associated with medical intervention, unscheduled contact (visit or telephone call) with a physician, (temporary) cessation of study treatment, or associated with discomfort for the patient such as pain, or impairment of activities of daily life.
Measured: Participants will be followed for the duration of hospital stay up to two days following hospital discharge, an expected average of 2 weeks
Minor Bleeding
All bleeding events that cannot be classified as major or clinically relevant non-major
Measured: Participants will be followed for the duration of hospital stay up to two days following hospital discharge, an expected average of 2 weeks
Symptomatic venous thromboembolism
Deep vein thrombosis will be confirmed by compression ultrasonography or venography. Pulmonary embolism will be confirmed by spiral computed tomography or V/Q lung scan
Measured: Participants will be followed for the duration of hospital stay up to one month after hospital discharge, an expected average of 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionJul 2021
- Study completionJul 2021
Why it stopped: Slow recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical PatientStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- G. d'Annunzio University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcello Di Nisio, G. d'Annunzio University
- Investigators
- Marcello Di Nisio, PhD, Study chair, G. d'Annunzio University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01727401
- Sponsor's protocol ID
- 213/2012
- Acronym
- FAITH
- Status last verified
- Jul 2021
- First submitted
- 8 Nov 2012
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thromboprophylaxis With Fondaparinux of Deep Vein Thrombosis and Pulmonary Embolism in the Acutely-ill Medical Inpatients With Thrombocytopenia
- ClinicalTrials.gov ID
- NCT01727401
- Acronym / sponsor ID
- FAITH / 213/2012
- Conditions
- Medical Patient, Thrombocytopenia
- Keywords
- Fondaparinux, medical patient, vein thromboembolism, prophylaxis, thrombocytopenia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment rate
- Enrolment
- 7 participants (actual)
- Lead sponsor
- G. d'Annunzio UniversityUniversity, hospital or other
- Study start
- Nov 2012 (actual)
- Primary completion
- Jul 2021 (actual)
- Study completion
- Jul 2021 (actual)
- First posted
- 16 Nov 2012 (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.
Fondaparinux is a parenteral anticoagulant drug approved for the prophylaxis of venous thromboembolism in high risk medical patients. A relevant proportion of these patients have renal insufficiency and/or thrombocytopenia which represent independent risk factors for bleeding. The risk of bleeding may be increased when fondaparinux is administered to patients with a reduced renal function and/or low platelet count. A lower dose of fondaparinux, 1.5 mg daily, has been approved for patients with renal insufficiency defined by a creatinine clearance between 20 and 50 mL/min. However, to our knowledge, there are no clinical studies that have specifically evaluated prophylaxis with fondaparinux in acutely-ill medical patients with a moderate to severe thrombocytopenia. The scope of this study is to evaluate the safety of fondaparinux in high risk hospitalized medical patients with a moderate to severe thrombocytopeniada defined by a platelet count between 100,000/uL and 30,000/uL.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fondaparinux | Experimental | Drug: FondaparinuxDrug: fondaparinux once daily sc injections 2.5 mg if renal clearance of creatinine above 50 ml/min once daily sc injections 1.5 mg if renal clearance of creatinine between 20 and 50 ml/min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age above 18 years;
- hospitalization in an Internal Medicine Unit and a Barbar score of 4 points or above
- Platelet count between 100,000/uL and 30,000/uL
- written informed consent
Key exclusion criteria (12 listed)
- Active bleeding or bleeding within the previous 3 months;
- Known bleeding diathesis;
- Active gastroduodenal ulcer;
- Severe renal insufficiency defined by a creatinine clearance below 20 mL/min;
- Ongoing treatment with unfractionated heparin, low-moleculr-weight heparin, fondaparinux, or oral anticoagulants Trattamento in corso con eparina non
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: ArixtraFondaparinux once daily sc injections at a dose of 2.5 mg if renal clearance of creatinine above 50 ml/min or Fondaparinux once daily sc injections 1.5 mg if renal clearance of creatinine between 20 and 50 ml/min | Drug | Fondaparinux |
Primary outcome
Major bleeding
Time frame: Participants will be followed for the duration of hospital stay up to two days following hospital discharge, an expected average of 2 weeks
Major bleeding will be defined as overt bleeding associated with: a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or whole blood, or bleeding that occurs in a critical site: intracranial, intra-spinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal or contributing to death.
3 secondary outcomes
Clinically relevant non-major bleeding
Time frame: Participants will be followed for the duration of hospital stay up to two days following hospital discharge, an expected average of 2 weeks
Minor Bleeding
Time frame: Participants will be followed for the duration of hospital stay up to two days following hospital discharge, an expected average of 2 weeks
Symptomatic venous thromboembolism
Time frame: Participants will be followed for the duration of hospital stay up to one month after hospital discharge, an expected average of 5 weeks
Results and safety
The study was stopped early (reason given: Slow recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
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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.
Marcello Di Nisio, PhD study chair
G. d'Annunzio University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fondaparinux in people with Medical Patient and Thrombocytopenia, run by G. d'Annunzio University at 1 site in Italy.
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 4 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: stopped early, as of the sponsor's last update on 21 Jul 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 Italy. 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?
The study was stopped early (reason given: Slow recruitment rate). 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?
Major bleeding (time frame: Participants will be followed for the duration of hospital stay up to two days following hospital discharge, an expected average of 2 weeks). 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 21 Jul 2021.