ICU Patients 18 Years or Older.NCT00424281
Effectiveness of Blood Clot Medication With Concomitant Blood Pressure Medication
An observational study of ICU Patients 18 Years or Older., run by Wayne State University at 1 site in United States.
Trial summary
Patients in intensive care units have higher risks for developing blood clots. Arixtra inhibits blood clot formation by binding with the blood clotting factor, Xa. Critical illnesses and, specifically, medications given in the ICU to increase arterial blood pressure (vasopressors) may impair the absorption of drugs… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ICU Patients 18 Years or Older.
- What is being tested?
- Arixtra (fondaparinux), 2.5 mg/day-what is bioavailability
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Jan 2010
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ICU patients 18 or over, weight 50 kg or more in the ICU will be enrollment eligible. Pregnant women and those with neuraxial anesthesia, renal or liver problems, or BMI over 40 are not eligible.
Who cannot join
- Patients under 18, weight less than 50 kg, pregnant women and those with neuraxial anesthesia, renal or liver problems, or BMI over 40 are not eligible.
Trial locations and contacts
1 site in 1 country.
United States1 site
Harper University Hospital, ICU
Detroit, Michigan, 48201
Jorge A. Guzman, MD, 313-745-8334, JGuzman@med.wayne.edu
Jorge A. Guzman, MD
About this study
Official title: Pharmacokinetics of Fondaparinux (Arixtra) to Critically Ill Patients on Vasopressor Therapy
Patients in intensive care units have higher risks for developing blood clots. Arixtra inhibits blood clot formation by binding with the blood clotting factor, Xa. Critical illnesses and, specifically, medications given in the ICU to increase arterial blood pressure (vasopressors) may impair the absorption of drugs like Arixtra that are given subcutaneously. The study will measure the levels of Arixtra in blood comparing those subjects who are and those subjects who are not on blood pressure medication.
Read the detailed description
In view of the high risk of venous thrombolism (VTE) in critically ill patients, it is essential for all ICUs to develop a standardized approach to thromboprophylaxis. Several studies in a critical setting have shown that both low dose unfractionated heparin and low molecular weight heparin (LMWH) reduce the incidence of VTE and either one of them is recommended as a valid agent by the newer ACCP consensus guidelines.
However, even with prophylaxis, critically ill patients still develop VTE. Common conditions amongst ICU patients such as generalized edema, poor peripheral perfusion during shock states, moderate renal dysfunction, etc., are possible explanations for this observation. Additionally, the use of vasoactive drugs may also impair peripheral circulation and reduce effective levels of agents used for the prevention of VTE.
This prospective clinical trial will be conducted to assess whether impaired peripheral circulation due to vasopressor (blood pressure) infusion decreases the bioavailability (i.e., plasma concentration) of subcutaneously administered fondaparinux (i.e., does vasopressor infusion lower blood plasma concentrations of fondaparinux), thereby reducing the prophylactic benefits of fondaparinux administration.
Fondaparinux (Arixtra®) was chosen as the anti-thrombotic agent to be used in this study because of its unique pharmacological properties and its safety and efficacy amongst different medical populations. Fondaparinux sodium administered by subcutaneous injection is rapidly and completely absorbed (absolute bioavailability is 100%). Following a single subcutaneous dose of fondaparinux sodium 2.5 mg in young male subjects, Cmax of 0.34 mg free acid/L is reached in approximately 2 hours. In patients undergoing treatment with fondaparinux sodium injection 2.5 mg, once daily, the peak steady-state plasma concentration is, on average, 0.39-0.50 mg free acid/L and is reached approximately 3 hours post-dose. Because fondaparinux does not react with platelet factor IV, thrombocytopenia is not an unwanted side effect.
- Conditions
- ICU Patients 18 Years or Older.
- Being tested
- Arixtra (fondaparinux), 2.5 mg/day-what is bioavailability
- Keywords
- Arixtra, fondaparinux, vasopressor, venous thrombolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arixtra (fondaparinux), 2.5 mg/day-what is bioavailabilityDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2007 (estimated)
- Study startFeb 2007
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ICU Patients 18 Years or Older.Studies 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
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Investigators
- M. Safwan Badr, MD, Study chair, Wayne State University, Division of Pulmonary, Asthma, Critical Care, and Sleep Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00424281
- Sponsor's protocol ID
- WSU protocol ID= 066706MP4F
- Status last verified
- Jan 2007
- First submitted
- 17 Jan 2007
- Last updated
- 19 Jan 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Fondaparinux (Arixtra) to Critically Ill Patients on Vasopressor Therapy
- ClinicalTrials.gov ID
- NCT00424281
- Acronym / sponsor ID
- WSU protocol ID= 066706MP4F
- Conditions
- ICU Patients 18 Years or Older.
- Keywords
- Arixtra, fondaparinux, vasopressor, venous thrombolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Feb 2007
- Study completion
- Jan 2010
- First posted
- 19 Jan 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.
Patients in intensive care units have higher risks for developing blood clots. Arixtra inhibits blood clot formation by binding with the blood clotting factor, Xa. Critical illnesses and, specifically, medications given in the ICU to increase arterial blood pressure (vasopressors) may impair the absorption of drugs like Arixtra that are given subcutaneously. The study will measure the levels of Arixtra in blood comparing those subjects who are and those subjects who are not on blood pressure medication.
Detailed description
In view of the high risk of venous thrombolism (VTE) in critically ill patients, it is essential for all ICUs to develop a standardized approach to thromboprophylaxis. Several studies in a critical setting have shown that both low dose unfractionated heparin and low molecular weight heparin (LMWH) reduce the incidence of VTE and either one of them is recommended as a valid agent by the newer ACCP consensus guidelines.
However, even with prophylaxis, critically ill patients still develop VTE. Common conditions amongst ICU patients such as generalized edema, poor peripheral perfusion during shock states, moderate renal dysfunction, etc., are possible explanations for this observation. Additionally, the use of vasoactive drugs may also impair peripheral circulation and reduce effective levels of agents used for the prevention of VTE.
This prospective clinical trial will be conducted to assess whether impaired peripheral circulation due to vasopressor (blood pressure) infusion decreases the bioavailability (i.e., plasma concentration) of subcutaneously administered fondaparinux (i.e., does vasopressor infusion lower blood plasma concentrations of fondaparinux), thereby reducing the prophylactic benefits of fondaparinux administration.
Fondaparinux (Arixtra®) was chosen as the anti-thrombotic agent to be used in this study because of its unique pharmacological properties and its safety and efficacy amongst different medical populations. Fondaparinux sodium administered by subcutaneous injection is rapidly and completely absorbed (absolute bioavailability is 100%). Following a single subcutaneous dose of fondaparinux sodium 2.5 mg in young male subjects, Cmax of 0.34 mg free acid/L is reached in approximately 2 hours. In patients undergoing treatment with fondaparinux sodium injection 2.5 mg, once daily, the peak steady-state plasma concentration is, on average, 0.39-0.50 mg free acid/L and is reached approximately 3 hours post-dose. Because fondaparinux does not react with platelet factor IV, thrombocytopenia is not an unwanted side effect.
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ICU patients 18 or over, weight 50 kg or more in the ICU will be enrollment eligible. Pregnant women and those with neuraxial anesthesia, renal or liver problems, or BMI over 40 are not eligible.
Key exclusion criteria (1 listed)
- Patients under 18, weight less than 50 kg, pregnant women and those with neuraxial anesthesia, renal or liver problems, or BMI over 40 are not eligible.
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 (fondaparinux), 2.5 mg/day-what is bioavailability | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2007.
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.
M. Safwan Badr, MD study chair
Wayne State University, Division of Pulmonary, Asthma, Critical Care, and Sleep Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ICU Patients 18 Years or Older., run by Wayne State University 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 19 Jan 2007. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jorge A. Guzman, MD (313/745-8334, JGuzman@med.wayne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 19 Jan 2007.