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

NCT00924859 | Completed

• 1 other identifier: 112/09
• Study Type: observational
• Target: 401
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Cerebral Venous Thrombosis

Keywords

cerebral venous thrombosis; stroke; coagulation

Outcome Measures

Primary Outcomes (1)

• The overall diagnostic accuracy of FXIII-AP an D-dimer to exclude CVT in patients with clinical suspicion of CVT

  at hospital entry

Secondary Outcomes (3)

• The overall frequency of CVT in patients with clinical suspicion of CVT

  at hospital entry

• The overall frequency of other diseases in patients with clinical suspicion of CVT

  at hospital entry

• The site of involved veins and sinus in patients with CVT

  at hospital entry

Study Arms (1)

1

Patients with clinical suspicion of CVT

Other: ELISA Test

Interventions

ELISA Test OTHER

assess the overall accuracy of D-dimer values and FXIII activation peptide (FXIII-AP), using a newly developed ELISA test

1

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive patients with clinical suspicion of CVT at the emergency department of the University Hospital (tertiary care clinic)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead
• Schweizerische Herzstiftung: collaborator

Study Sites (2)

Department of Neurology, Academic Medical Centre, University of Amsterdam

Amsterdam, 1100, Netherlands

Location

Dep. of Neurology, Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (1)

• Heldner MR, Zuurbier SM, Li B, Von Martial R, Meijers JCM, Zimmermann R, Volbers B, Jung S, El-Koussy M, Fischer U, Kohler HP, Schroeder V, Coutinho JM, Arnold M. Prediction of cerebral venous thrombosis with a new clinical score and D-dimer levels. Neurology. 2020 Aug 18;95(7):e898-e909. doi: 10.1212/WNL.0000000000009998. Epub 2020 Jun 23.

  PMID: 32576633 DERIVED

MeSH Terms

Conditions

Intracranial Thrombosis; Stroke; Thrombosis

Condition Hierarchy (Ancestors)

Intracranial Embolism and Thrombosis; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Thromboembolism; Embolism and Thrombosis

Study Officials

• Marcel Arnold, MD Prof.

  Dep. of Neurology, Bern University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 15, 2009
• First Posted: June 19, 2009
• Study Start: September 1, 2009
• Primary Completion: December 31, 2017
• Study Completion: December 31, 2017
• Last Updated: October 12, 2018

Record last verified: 2018-10

Locations

CH (1); NL (1)