Venous ThrombosisPhase 2NCT00436787
Investigation Into the Therapeutic Dosage of Fondaparinux Sodium, a Medication Used to Prevent Blood Clots in Morbidly Obese Volunteers
A Phase 2 study testing Fondaparinux Sodium in people with Venous Thrombosis and Pulmonary Embolism, run by University of Pittsburgh at 2 sites in United States.
Trial summary
Morbidly obese individuals are at high risk for potentially life threatening blood clots around the time of abdominal surgical procedures. Fondaparinux sodium (Arixtra) is an FDA- approved medication used in the prevention of deep venous thrombosis (DVT) at the time of orthopedic or abdominal surgery, as well as for… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Venous Thrombosis, Pulmonary Embolism
- What is being tested?
- Fondaparinux Sodium
- How many people
- 21 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2007to Dec 2007
- Phase
- Phase 2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 19-65 years
- BMI 35-65 Kg/m2
- Pregnancy test Negative on day of study
- Past DVT/PE/MI These patients will not be excluded providing they are not on current therapy with anticoagulants, aspirin, or anti-platelet agents.
Who cannot join
- BP ≥ 160/90
- Temperature > 37.5 0C (99.5 0F)
- Nursing mothers Exclude if nursing
- Pregnancy test Positive on day of study
- Medications Anticoagulants, anti-platelet agents, aspirin, NSAIDs within a month of the study
- Past medical history
Show all 27Show fewer
- cerebrovascular accident (including TIA within 6 months of the study)
- Diabetic retinopathy proven by fundoscopy
- History of inherited thrombotic/hypercoagulable defect
- Active peptic ulcer disease diagnosed by upper endoscopy
- Known bleeding disorder, thrombophilia
- History of heparin induced thrombocytopenia
- History of bacterial endocarditis
- Known hypersensitivity to fondaparinux
- Ulcerative colitis
- History of GI bleeding
- History of hematuria
- Recent surgery (last 3 months)
- Recent trauma (last 3 months)
- Laboratory values
- Platelet count ≤ 100,000 mm3
- Hemoglobin < 12 g/dL (women), or < 14 g/dL (men)
- Prothrombin time > 13 sec
- PTT > 35 sec
- ALT 3xULN and bilirubin 1.5xULN (>35% direct); or ALT 5xULN; or ALT 3xULN if associated with the appearance or worsening of hepatitis symptoms or rash
- Estimated urinary creatinine clearance ≤ 50 ml/min
- Hematuria on urine dipstick
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Magee Women's Hospital
Pittsburgh, Pennsylvania, 15213
Shadyside Medical Building
Pittsburgh, Pennsylvania, 15232
About this study
Official title: Pharmacokinetic Properties of Fondaparinux Sodium in Morbidly Obese Volunteers
Morbidly obese individuals are at high risk for potentially life threatening blood clots around the time of abdominal surgical procedures. Fondaparinux sodium (Arixtra) is an FDA- approved medication used in the prevention of deep venous thrombosis (DVT) at the time of orthopedic or abdominal surgery, as well as for the treatment of DVT and pulmonary embolism (PE). As with many medications, therapeutic dosages have not been fully investigated for the morbidly obese population. Our goal is to study the therapeutic blood levels, after 2 different dosages of the medication are given to morbidly obese volunteers. We will recruit 21 morbidly obese (Body Mass Index (BMI) > 35) individuals who are in the evaluation process for bariatric surgery. They will be divided into 7 groups: 3 participants with BMI 35 - 39.9, 3 with a BMI of 40 - 49.9, 3 with a BMI of 50 - 59.9, 3 with a BMI > 60, 3 with a weight of 100 - 149 KG, 3 with a weight of 150 - 199 KG and 3 with a weight of 200 - 249 KG. Participants will be administered two different doses of the medication with a 2-week interval in between, then blood will be drawn in various intervals throughout the next 48 hours to see which dose provides the best therapeutic levels. Participants will be monitored closely for any side effects or complications.
Read the detailed description
Bariatric surgery carries a mortality rate of 0.5-1%, with PE found to be the most frequent postoperative complications and causes of death. Currently employed prophylactic methods include unfractionated or low molecular weight heparins in combination with mechanical calf compression. However, despite the implementation of these standard measures, the reported incidence of fatal PE has ranged from 0.2 to 0.64% accounting for between 30 to 50% of deaths after bariatric surgery.
With a reported 40,000 bariatric surgical procedures in 2001, and the numbers growing rapidly every year, there is clearly a need for a more effective prophylaxis from DVT and PE. The pentasaccharide fondaparinux is an anti-thrombotic agent used in the prophylaxis of venous thromboembolism after orthopedic or abdominal surgery. Its clinical value has been established in multiple randomized double blind studies in high-risk major orthopedic surgery where it showed a 55% greater reduction in DVT episodes compared to enoxaparin (Lovenox®) Although fondaparinux has been administered in obese patients in clinical studies for prevention of venous thromboembolism after orthopedic surgery and preliminary results show no influence of ABW on the clinical outcome, the pharmacokinetic properties of the drug in the morbidly obese have not been investigated. Previously published fondaparinux pharmacokinetic studies excluded patients whose body weight was more than 30% of ideal, with the heaviest group being 77.2+/-10.1 Kg and with a BMI of 25.7+/2.6 Kg/m2. Similar studies on low molecular weight heparins, such as enoxaparin and dalteparin, showed predictable anti-Xa activity with weight-based dosing in the morbidly obese.
There has been no study on the pharmacokinetics of this drug in the morbidly obese (BMI>35 Kg/m2). It is clinically imperative to have a predictable anti-Xa level and a predictable DVT prophylactic effect in the morbidly obese whose body weight may vary by as much as 3 to 4 fold higher compared to the average 70 Kg adult. This has become a critical issue in view of the large number of bariatric surgical operations being undertaken, which has increased 150% in the last two years.
The purpose of this study is to assess the pharmacokinetic properties of fondaparinux in morbidly obese volunteers. This is a prospective crossover, randomized study with a 2-week washout period comparing two dosing regimens of fondaparinux in morbidly obese volunteers.
- Conditions
- Venous Thrombosis, Pulmonary Embolism
- Being tested
- Fondaparinux Sodium
- Keywords
- Anticoagulation Prophylaxis, Venous Thrombosis, Deep Vein Thrombosis, Pulmonary Embolism, Fondaparinux Sodium, Arixtra, Pharmakinetics
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fondaparinux SodiumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The pharmacokinetic properties of fondaparinux sodium in morbidly obese individuals.
Secondary outcomes (4)
Comparisons of the pharmacokinetic parameters of morbidly obese participants receiving 2.5 mg or 5 mg dose of fondaparinux sodium with those of healthy normal-weight volunteers established from previous studies.
Comparison of the pharmacokinetic parameters of the 2.5 mg and 5 mg dosage of fondaparinux sodium.
Evaluate the effect of BMI and ABW on the pharmacokinetic parameters of the 2.5 mg and 5 mg dosages of fondaparinux sodium.
Assess the safety of fondaparinux sodium, as measured by defined safety endpoints, and compare the 2 dose groups for differences in the incidence of adverse events (AE).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2007 (estimated)
- Study startFeb 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- 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
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- Ioannis Raftopoulos, MD, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00436787
- Sponsor's protocol ID
- ART108029
- Status last verified
- May 2008
- First submitted
- 16 Feb 2007
- Last updated
- 16 May 2008
- Results posted
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Properties of Fondaparinux Sodium in Morbidly Obese Volunteers
- ClinicalTrials.gov ID
- NCT00436787
- Acronym / sponsor ID
- ART108029
- Conditions
- Venous Thrombosis, Pulmonary Embolism
- Keywords
- Anticoagulation Prophylaxis, Venous Thrombosis, Deep Vein Thrombosis, Pulmonary Embolism, Fondaparinux Sodium, Arixtra, Pharmakinetics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Feb 2007
- Study completion
- Dec 2007 (actual)
- First posted
- 19 Feb 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.
Morbidly obese individuals are at high risk for potentially life threatening blood clots around the time of abdominal surgical procedures. Fondaparinux sodium (Arixtra) is an FDA- approved medication used in the prevention of deep venous thrombosis (DVT) at the time of orthopedic or abdominal surgery, as well as for the treatment of DVT and pulmonary embolism (PE). As with many medications, therapeutic dosages have not been fully investigated for the morbidly obese population. Our goal is to study the therapeutic blood levels, after 2 different dosages of the medication are given to morbidly obese volunteers. We will recruit 21 morbidly obese (Body Mass Index (BMI) > 35) individuals who are in the evaluation process for bariatric surgery. They will be divided into 7 groups: 3 participants with BMI 35 - 39.9, 3 with a BMI of 40 - 49.9, 3 with a BMI of 50 - 59.9, 3 with a BMI > 60, 3 with a weight of 100 - 149 KG, 3 with a weight of 150 - 199 KG and 3 with a weight of 200 - 249 KG. Participants will be administered two different doses of the medication with a 2-week interval in between, then blood will be drawn in various intervals throughout the next 48 hours to see which dose provides the best therapeutic levels. Participants will be monitored closely for any side effects or complications.
Detailed description
Bariatric surgery carries a mortality rate of 0.5-1%, with PE found to be the most frequent postoperative complications and causes of death. Currently employed prophylactic methods include unfractionated or low molecular weight heparins in combination with mechanical calf compression. However, despite the implementation of these standard measures, the reported incidence of fatal PE has ranged from 0.2 to 0.64% accounting for between 30 to 50% of deaths after bariatric surgery.
With a reported 40,000 bariatric surgical procedures in 2001, and the numbers growing rapidly every year, there is clearly a need for a more effective prophylaxis from DVT and PE. The pentasaccharide fondaparinux is an anti-thrombotic agent used in the prophylaxis of venous thromboembolism after orthopedic or abdominal surgery. Its clinical value has been established in multiple randomized double blind studies in high-risk major orthopedic surgery where it showed a 55% greater reduction in DVT episodes compared to enoxaparin (Lovenox®) Although fondaparinux has been administered in obese patients in clinical studies for prevention of venous thromboembolism after orthopedic surgery and preliminary results show no influence of ABW on the clinical outcome, the pharmacokinetic properties of the drug in the morbidly obese have not been investigated. Previously published fondaparinux pharmacokinetic studies excluded patients whose body weight was more than 30% of ideal, with the heaviest group being 77.2+/-10.1 Kg and with a BMI of 25.7+/2.6 Kg/m2. Similar studies on low molecular weight heparins, such as enoxaparin and dalteparin, showed predictable anti-Xa activity with weight-based dosing in the morbidly obese.
There has been no study on the pharmacokinetics of this drug in the morbidly obese (BMI>35 Kg/m2). It is clinically imperative to have a predictable anti-Xa level and a predictable DVT prophylactic effect in the morbidly obese whose body weight may vary by as much as 3 to 4 fold higher compared to the average 70 Kg adult. This has become a critical issue in view of the large number of bariatric surgical operations being undertaken, which has increased 150% in the last two years.
The purpose of this study is to assess the pharmacokinetic properties of fondaparinux in morbidly obese volunteers. This is a prospective crossover, randomized study with a 2-week washout period comparing two dosing regimens of fondaparinux in morbidly obese volunteers.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 19-65 years
- BMI 35-65 Kg/m2
- Pregnancy test Negative on day of study
- Past DVT/PE/MI These patients will not be excluded providing they are not on current therapy with anticoagulants, aspirin, or anti-platelet agents.
Key exclusion criteria (27 listed)
- BP ≥ 160/90
- Temperature > 37.5 0C (99.5 0F)
- Nursing mothers Exclude if nursing
- Pregnancy test Positive on day of study
- Medications Anticoagulants, anti-platelet agents, aspirin, NSAIDs within a month of the study
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 |
|---|---|---|
| Fondaparinux Sodium | Drug | – |
Primary outcome
The pharmacokinetic properties of fondaparinux sodium in morbidly obese individuals.
4 secondary outcomes
Comparisons of the pharmacokinetic parameters of morbidly obese participants receiving 2.5 mg or 5 mg dose of fondaparinux sodium with those of healthy normal-weight volunteers established from previous studies.
Comparison of the pharmacokinetic parameters of the 2.5 mg and 5 mg dosage of fondaparinux sodium.
Evaluate the effect of BMI and ABW on the pharmacokinetic parameters of the 2.5 mg and 5 mg dosages of fondaparinux sodium.
Assess the safety of fondaparinux sodium, as measured by defined safety endpoints, and compare the 2 dose groups for differences in the incidence of adverse events (AE).
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 16 May 2008.
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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.
Ioannis Raftopoulos, MD, PhD principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fondaparinux Sodium in people with Venous Thrombosis and Pulmonary Embolism, run by University of Pittsburgh 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 4 inclusion and 27 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 16 May 2008. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
The pharmacokinetic properties of fondaparinux sodium in morbidly obese individuals.. 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 16 May 2008.