The Role of Factor XIII Activation Peptide and D-dimer Values for the Diagnosis of Cerebral Venous Thrombosis (CVT)
This study is currently recruiting participants.
(see Contacts and Locations)
Verified April 2016 by University Hospital Inselspital, Berne
Sponsor:
University Hospital Inselspital, Berne
Collaborator:
Schweizerische Herzstiftung
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00924859
First received: June 15, 2009
Last updated: April 11, 2016
Last verified: April 2016
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Purpose
The investigators aim to assess the overall accuracy of D-dimer values and FXIII activation peptide (FXIII-AP), using a newly developed ELISA test, to exclude CVT in patients with clinical suspicion of CVT.
| Condition | Intervention |
|---|---|
|
Cerebral Venous Thrombosis |
Other: ELISA Test |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | The Role of Factor XIII Activation Peptide and D-dimer Values for the Diagnosis of Cerebral Venous Thrombosis |
Resource links provided by NLM:
Further study details as provided by University Hospital Inselspital, Berne:
Primary Outcome Measures:
- The overall diagnostic accuracy of FXIII-AP an D-dimer to exclude CVT in patients with clinical suspicion of CVT [ Time Frame: at hospital entry ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The overall frequency of CVT in patients with clinical suspicion of CVT [ Time Frame: at hospital entry ] [ Designated as safety issue: No ]
- The overall frequency of other diseases in patients with clinical suspicion of CVT [ Time Frame: at hospital entry ] [ Designated as safety issue: No ]
- The site of involved veins and sinus in patients with CVT [ Time Frame: at hospital entry ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 300 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
1
Patients with clinical suspicion of CVT
|
Other: ELISA Test
assess the overall accuracy of D-dimer values and FXIII activation peptide (FXIII-AP), using a newly developed ELISA test
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
Consecutive patients with clinical suspicion of CVT at the emergency department of the University Hospital (tertiary care clinic)
Criteria
Inclusion Criteria:
- Adults with clinical suspicion of CVT
- Isolated unexplained headache of less than 30 days duration
- Headache associated with focal central neurological deficits of less than 30 days duration
- Headache associated with disturbed consciousness of less than 30 days duration
- Headache associated with epileptic seizures of less than 30 days duration
- Unexplained papilledema of less than 30 days duration
Exclusion Criteria
- Deep venous thrombosis within 3 months prior to admission
- Pulmonary embolism within 3 months prior to admission
- Ischemic stroke within 3 months prior to admission
- Myocardial infarction within 3 months prior to admission
- Other vascular disease within 3 months prior to admission
- Headache due to trauma
- Malignant neoplasia
- Treatment with anticoagulants prior to admission
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00924859
Please refer to this study by its ClinicalTrials.gov identifier: NCT00924859
Contacts
| Contact: Marcel Arnold, MD Prof. | +41316323332 | Marcel.Arnold@insel.ch |
Locations
| Netherlands | |
| Department of Neurology, Academic Medical Centre, University of Amsterdam | Recruiting |
| Amsterdam, Netherlands, 1100 | |
| Contact: J. Coutinho, Dr. +31 20 5664591 j..coutinho@amc.uva.nl | |
| Principal Investigator: J. Stam, Prof. | |
| Principal Investigator: J. Coutinho, Dr. | |
| Switzerland | |
| Dep. of Neurology, Bern University Hospital | Recruiting |
| Bern, Switzerland, 3010 | |
| Principal Investigator: Marcel Arnold, MD Prof. | |
Sponsors and Collaborators
University Hospital Inselspital, Berne
Schweizerische Herzstiftung
Investigators
| Principal Investigator: | Marcel Arnold, MD Prof. | Dep. of Neurology, Bern University Hospital |
More Information
| Responsible Party: | Departement of Neurology, Inselspital Bern, Universitiy Hospital |
| ClinicalTrials.gov Identifier: | NCT00924859 History of Changes |
| Other Study ID Numbers: | 112/09 |
| Study First Received: | June 15, 2009 |
| Last Updated: | April 11, 2016 |
| Health Authority: | Switzerland: Ethikkommission |
Keywords provided by University Hospital Inselspital, Berne:
|
cerebral venous thrombosis stroke coagulation |
Additional relevant MeSH terms:
|
Venous Thrombosis Thrombosis Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Fibrin fragment D |
Antifibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Hemostatics Coagulants |
ClinicalTrials.gov processed this record on September 28, 2016