The Role of Factor XIII Activation Peptide and D-dimer Values for the Diagnosis of Cerebral Venous Thrombosis (CVT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by University Hospital Inselspital, Berne.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Schweizerische Herzstiftung
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00924859
First received: June 15, 2009
Last updated: June 20, 2012
Last verified: June 2012
  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: 200
Study Start Date: September 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (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

Detailed Description:

Background

Because of the broad clinical spectrum it is often difficult to establish the diagnosis of cerebral venous thrombosis (CVT). Combined MRI/MRV and contrast-enhanced CT are the most accurate methods for diagnosis of CVT. However these methods are often not available on an emergency basis. This stresses the need for additional widely available tests such as coagulation markers to exclude CVT. The diagnostic value of D-dimer levels for the exclusion of CVT is still under debate. Other potential coagulation markers have not been systematically investigated. We 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. Consecutive patients with clinical suspicion of CVT at the emergency department of the University Hospital Bern will be included in this study over a two year period. All included patients will receive standard care applied by the treating physician who will follow international recommendations. Patient involvement in the study shall not influence any treatment decision. On admission patients will undergo a complete diagnostic work-up, including a clinical neurological examination, standard laboratory examination including D-dimer values, and brain contrast CT and/or MRI/MRV. In addition, plasma FXIII-AP will be analyzed. FXIII-AP will be analyzed at the Hemostasis Research Laboratory, Department of Hematology, University of Bern, based on a newly developed highly sensitive and specific ELISA method. The investigators will be blinded for the clinical symptoms and diagnosis of the patient. The study will be conducted according to the guidelines of the STARD (Standards for Reporting Diagnostic Accuracy) initiative.

The following primary evaluation criteria will be analysed:1) The overall diagnostic accuracy of FXIII-AP to exclude CVT in patients with clinical suspicion of CVT; 2) The overall diagnostic accuracy of D-dimer to exclude CVT in patients with clinical suspicion of CVT; 3) Roc curves will be calculated.

Prespecified subgroup analyses will be performed according to the clinical presentation: 1) isolated headache; 2) isolated intracranial hypertension (headache and papilledema); 3) Focal neurological deficits and/or seizures and/or disturbances of consciousness. Furthermore, prespecified subgroup analyses will be performed according to modes of onset: 1) acute (symptoms < 48 hours duration); 2) subacute (symptoms > 48 hours and < 7 days duration); 3) chronic (symptoms > 7 days duration).

The following secondary evaluation criteria will be assessed: 1) The overall frequency of CVT in patients with clinical suspicion of CVT; 2) The overall frequency of other diseases in patients with clinical suspicion of CVT; 3) The site of involved veins and sinus in patients with CVT.

Objective

We 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.

Methods

Consecutive patients with clinical suspicion of CVT at the emergency department of the University Hospital Bern will be included in this study over a two year period. All included patients will receive standard care applied by the treating physician who will follow international recommendations. D-dimer measurement at entry will be performed using a rapid sensitive assay. FXIII-AP will be analyzed at the Hemostasis Research Laboratory, Department of Hematology, University of Bern based on a highly sensitive and specific ELISA method.The investigators will be blinded for the clinical symptoms and diagnosis of the patient.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
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
  • solated 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

Contacts
Contact: Marcel Arnold, MD +41316323332 Marcel.Arnold@insel.ch
Contact: Oliver Findling, MD +41316323332 Oliver.Findling@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         
Sponsors and Collaborators
University Hospital Inselspital, Berne
Schweizerische Herzstiftung
Investigators
Principal Investigator: Marcel Arnold, MD Dep. of Neurology, Bern University Hospital
  More Information

No publications provided

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: June 20, 2012
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital Inselspital, Berne:
cerebral venous thrombosis
stroke
coagulation

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Thromboembolism

ClinicalTrials.gov processed this record on August 18, 2014