Clot Formation and Platelet Aggregation in Point of Care TestingNCT01704053
Effect of New Oral Anticoagulants Dabigatran and Rivaroxaban on Point of Care Coagulation Testing - an Ex-Vivo Study
An observational study of Clot Formation and Platelet Aggregation in Point of Care Testing, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
The purpose of this study is determine whether point of care coagulation testing is able to map the anticoagulatory effects of new oral anticoagulants dabigatran and rivaroxaban. Used as devices are thrombelastometry/-graphy (ROTEM, TEG)and multiple platelet function analyzer (Multiplate). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clot Formation and Platelet Aggregation in Point of Care Testing
- How many people
- 34 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2012to Mar 2014
- 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: Primary Care Clinic. Patients with non-valvular atrial fibrillation who receive Dabigatran or Rivaroxaban for prevention of stroke and systemic embolism.
Who may be able to join
- Patients receiving Dabigatran or Rivaroxaban
- Adults > 18 years
Who cannot join
- Patients receiving concomittantly inhibitors of platelet function
- Renal insufficiency (Creatinine > 1,5 mg/dl), Urea > 80 mg/dl)
- Hemodialysis
- Hepatic Dysfunction (AST > 30 U/l, ALT > 30 U/l)
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital of University hospital of Frankfurt/Main, Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy
Frankfurt am Main, Hesse, 60590
About this study
Official title: Monitoring The Anticoagulatory Effects of Dabigatran and Rivaroxaban On Plasmatic and Cellular Coagulation by Rotational Thrombelastometry/-Graphy and Multiple Platelet Function Analyzer
The purpose of this study is determine whether point of care coagulation testing is able to map the anticoagulatory effects of new oral anticoagulants dabigatran and rivaroxaban. Used as devices are thrombelastometry/-graphy (ROTEM, TEG)and multiple platelet function analyzer (Multiplate).
Read the detailed description
Patients receiving dabigatran or rivaroxaban in therapeutic doses are recruited. Blood will be taken twice in correlation to the time of drug intake (before and 3 hours after drug intake). The results of thrombelastometry/-graphy and multiple platelet function analyzer will be compared directly with the concentrations determined by plasma concentration assays.
- Keywords
- New Oral Anticoagulants, Dabigatran, Rivaroxaban, Thrombelastometry/-graphy (ROTEM, TEG), Multiple Platelet Function Analyzer (Multiplate)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clot Formation and Platelet Aggregation in Point of Care TestingStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Matthias Klages, Johann Wolfgang Goethe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01704053
- Sponsor's protocol ID
- NOAPOC-271/12
- Status last verified
- Aug 2014
- First submitted
- 8 Oct 2012
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monitoring The Anticoagulatory Effects of Dabigatran and Rivaroxaban On Plasmatic and Cellular Coagulation by Rotational Thrombelastometry/-Graphy and Multiple Platelet Function Analyzer
- ClinicalTrials.gov ID
- NCT01704053
- Acronym / sponsor ID
- NOAPOC-271/12
- Keywords
- New Oral Anticoagulants, Dabigatran, Rivaroxaban, Thrombelastometry/-graphy (ROTEM, TEG), Multiple Platelet Function Analyzer (Multiplate)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 11 Oct 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.
The purpose of this study is determine whether point of care coagulation testing is able to map the anticoagulatory effects of new oral anticoagulants dabigatran and rivaroxaban. Used as devices are thrombelastometry/-graphy (ROTEM, TEG)and multiple platelet function analyzer (Multiplate).
Detailed description
Patients receiving dabigatran or rivaroxaban in therapeutic doses are recruited. Blood will be taken twice in correlation to the time of drug intake (before and 3 hours after drug intake). The results of thrombelastometry/-graphy and multiple platelet function analyzer will be compared directly with the concentrations determined by plasma concentration assays.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Clinic. Patients with non-valvular atrial fibrillation who receive Dabigatran or Rivaroxaban for prevention of stroke and systemic embolism.
Key inclusion criteria (2 listed)
- Patients receiving Dabigatran or Rivaroxaban
- Adults > 18 years
Key exclusion criteria (4 listed)
- Patients receiving concomittantly inhibitors of platelet function
- Renal insufficiency (Creatinine > 1,5 mg/dl), Urea > 80 mg/dl)
- Hemodialysis
- Hepatic Dysfunction (AST > 30 U/l, ALT > 30 U/l)
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
Not reported in the source record.
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 15 Aug 2014.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Clot Formation and Platelet Aggregation in Point of Care Testing, 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 2 inclusion and 4 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 15 Aug 2014. 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?
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.
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 15 Aug 2014.