The Role of Factor XIII Activation Peptide and D-dimer Values for the Diagnosis of Cerebral Venous Thrombosis (CVT)
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ClinicalTrials.gov Identifier: NCT00924859 |
Recruitment Status
:
Recruiting
First Posted
: June 19, 2009
Last Update Posted
: September 28, 2017
|
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Condition or disease | Intervention/treatment |
---|---|
Cerebral Venous Thrombosis | Other: ELISA Test |

Study Type : | Observational |
Estimated Enrollment : | 300 participants |
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 |
Actual Study Start Date : | September 2009 |
Estimated Primary Completion Date : | December 31, 2017 |
Estimated Study Completion Date : | December 31, 2017 |

Group/Cohort | Intervention/treatment |
---|---|
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
|
- 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 ]
- The overall frequency of CVT in patients with clinical suspicion of CVT [ Time Frame: at hospital entry ]
- The overall frequency of other diseases in patients with clinical suspicion of CVT [ Time Frame: at hospital entry ]
- The site of involved veins and sinus in patients with CVT [ Time Frame: at hospital entry ]

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Ages Eligible for Study: | 18 Years to 85 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00924859
Contact: Marcel Arnold, MD Prof. | +41316323332 | Marcel.Arnold@insel.ch |
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. |
Principal Investigator: | Marcel Arnold, MD Prof. | Dep. of Neurology, Bern University Hospital |
Responsible Party: | Departement of Neurology, Inselspital Bern, Universitiy Hospital |
ClinicalTrials.gov Identifier: | NCT00924859 History of Changes |
Other Study ID Numbers: |
112/09 |
First Posted: | June 19, 2009 Key Record Dates |
Last Update Posted: | September 28, 2017 |
Last Verified: | September 2017 |
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 |