Anticoagulant Prophylaxis/TherapyNCT01101256
Determination of Residual Anticoagulatory Effects of Fondaparinux
An observational study of Anticoagulant Prophylaxis/Therapy, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
The purpose of this study is to determine residual anticoagulatory effects of a prophylactic or therapeutic fondaparinux treatment i.e. prior to surgery/intervention, after pause of therapy etc. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anticoagulant Prophylaxis/Therapy
- How many people
- 110 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2010to Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with s.c. anticoagulant therapy (fondaparinux)
Who may be able to join
- Fondaparinux therapy for at least 3 days
Who cannot join
- Age < 18 years
- Hemodialysis
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
J.W. Goethe University Hospital Frankfurt/M.
Frankfurt am Main, Hesse, 60590
Marc Schindewolf, MD, +49 (0)69-6301 ext. 5096, marcschindewolf@yahoo.com
Edelgard Lindhoff-Last, MD, +49 (0)69-6301 ext. 5096, lindhoff-last@em.uni-frankfurt.de
About this study
Official title: Determination of Residual Anticoagulatory Effects of Prophylactic or Therapeutic Treatment With Fondaparinux
The purpose of this study is to determine residual anticoagulatory effects of a prophylactic or therapeutic fondaparinux treatment i.e. prior to surgery/intervention, after pause of therapy etc.
- Conditions
- Anticoagulant Prophylaxis/Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Fondaparinux Prophylaxis group | Not described | |
| Fondaparinux Therapy group | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
antiXa-levels (peak- and through-levels)
Measured: between day 3 and day 14 after start of therapy
Secondary outcomes (1)
thromboembolic or bleeding episodes, HIT
Measured: day 14 after start of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionSep 2010 (estimated)
- Study completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anticoagulant Prophylaxis/TherapyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Marc Schindewolf, MD, Principal investigator, J.W. Goethe University Hospital Frankfurt/M.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01101256
- Sponsor's protocol ID
- 66/09
- Status last verified
- Apr 2010
- First submitted
- 7 Apr 2010
- Last updated
- 13 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Paolucci F, Frasa H, Van Aarle F, Capdevla A, Clavies MC, van Dinther T, Donat F, Hendriks Y, van den Heuvel M, Nadal T, Lagrange F, Necciari J, Perez Y. Two sensitive and rapid chromogenic assays of fondaparinux sodium (Arixtra) in human plasma and other biological matrices. Clin Lab. 2003;49(9-10):451-60.
PubMed 14572200
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Residual Anticoagulatory Effects of Prophylactic or Therapeutic Treatment With Fondaparinux
- ClinicalTrials.gov ID
- NCT01101256
- Acronym / sponsor ID
- 66/09
- Conditions
- Anticoagulant Prophylaxis/Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 9 Apr 2010 (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.
The purpose of this study is to determine residual anticoagulatory effects of a prophylactic or therapeutic fondaparinux treatment i.e. prior to surgery/intervention, after pause of therapy etc.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fondaparinux Prophylaxis group | – | – |
| Fondaparinux Therapy group | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with s.c. anticoagulant therapy (fondaparinux)
Key inclusion criteria (1 listed)
- Fondaparinux therapy for at least 3 days
Key exclusion criteria (2 listed)
- Age < 18 years
- Hemodialysis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
antiXa-levels (peak- and through-levels)
Time frame: between day 3 and day 14 after start of therapy
1 secondary outcome
thromboembolic or bleeding episodes, HIT
Time frame: day 14 after start of therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2010.
- Background: PubMed 14572200Paolucci F, Frasa H, Van Aarle F, Capdevla A, Clavies MC, van Dinther T, Donat F, Hendriks Y, van den Heuvel M, Nadal T, Lagrange F, Necciari J, Perez Y. Two sensitive and rapid chromogenic assays of fondaparinux sodium (Arixtra) in human plasma and other biological matrices. Clin Lab. 2003;49(9-10):451-60.
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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.
Marc Schindewolf, MD principal investigator
J.W. Goethe University Hospital Frankfurt/M.
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 Anticoagulant Prophylaxis/Therapy, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
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 2 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 13 Apr 2010. 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 Germany. 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 Marc Schindewolf, MD (+49 (0)69 6301 ext. 5096, marcschindewolf@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
antiXa-levels (peak- and through-levels) (time frame: between day 3 and day 14 after start of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01101256, which also lists 1 linked publication.
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 13 Apr 2010.