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.

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Contacts and Locations

Verified September 2017 by University Hospital Inselspital, Berne

Sponsor:

ClinicalTrials.gov Identifier:

NCT00924859

First Posted: June 19, 2009

Last Update Posted: September 28, 2017

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.

Collaborator:

Schweizerische Herzstiftung

Information provided by:

University Hospital Inselspital, Berne

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:

MedlinePlus related topics: Blood Clots Deep Vein Thrombosis

Drug Information available for: Blood-coagulation factor XIII

U.S. FDA Resources

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 ]

Secondary Outcome Measures:

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 ]


Estimated Enrollment:	300
Actual Study Start Date:	September 2009
Estimated Study Completion Date:	December 31, 2017
Estimated Primary Completion Date:	December 31, 2017 (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

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Eligibility

Information from the National Library of Medicine

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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

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

Information from the National Library of Medicine

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

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
First Submitted:	June 15, 2009
First Posted:	June 19, 2009
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

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