Cerebral Venous ThrombosisNCT00924859
The Role of Factor XIII Activation Peptide and D-dimer Values for the Diagnosis of Cerebral Venous Thrombosis (CVT)
An observational study of Cerebral Venous Thrombosis, run by Insel Gruppe AG, University Hospital Bern at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Cerebral Venous Thrombosis
- What is being tested?
- ELISA Test
- How many people
- 401 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2009to 31 Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients with clinical suspicion of CVT at the emergency department of the University Hospital (tertiary care clinic)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Netherlands1 site
Department of Neurology, Academic Medical Centre, University of Amsterdam
Amsterdam, 1100
About this study
Official title: The Role of Factor XIII Activation Peptide and D-dimer Values for the Diagnosis of Cerebral Venous Thrombosis
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.
Read the 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. 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. 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
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.
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.
- Conditions
- Cerebral Venous Thrombosis
- Being tested
- ELISA Test
- Keywords
- cerebral venous thrombosis, stroke, coagulation
- Medical subject headings
- Intracranial Thrombosis, Stroke, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELISA TestOther
assess the overall accuracy of D-dimer values and FXIII activation peptide (FXIII-AP), using a newly developed ELISA test
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients with clinical suspicion of CVT Receives: Other: ELISA Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall diagnostic accuracy of FXIII-AP an D-dimer to exclude CVT in patients with clinical suspicion of CVT
Measured: at hospital entry
Secondary outcomes (3)
The overall frequency of CVT in patients with clinical suspicion of CVT
Measured: at hospital entry
The overall frequency of other diseases in patients with clinical suspicion of CVT
Measured: at hospital entry
The site of involved veins and sinus in patients with CVT
Measured: at hospital entry
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2009 (estimated)
- Study startSep 2009
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 401 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Collaborators
- Schweizerische Herzstiftung
- Investigators
- Marcel Arnold, MD Prof., Principal investigator, Dep. of Neurology, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00924859
- Sponsor's protocol ID
- 112/09
- Status last verified
- Oct 2018
- First submitted
- 15 Jun 2009
- Last updated
- 12 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 32576633
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Factor XIII Activation Peptide and D-dimer Values for the Diagnosis of Cerebral Venous Thrombosis
- ClinicalTrials.gov ID
- NCT00924859
- Acronym / sponsor ID
- 112/09
- Conditions
- Cerebral Venous Thrombosis
- Keywords
- cerebral venous thrombosis, stroke, coagulation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 401 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Collaborators
- Schweizerische Herzstiftung
- Study start
- Sep 2009 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 19 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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. 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. 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
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: ELISA TestPatients with clinical suspicion of CVT |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients with clinical suspicion of CVT at the emergency department of the University Hospital (tertiary care clinic)
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELISA Testassess the overall accuracy of D-dimer values and FXIII activation peptide (FXIII-AP), using a newly developed ELISA test | Other | 1 |
Primary outcome
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
3 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2018.
- Derived from this study: PubMed 32576633Heldner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcel Arnold, MD Prof. principal investigator
Dep. of Neurology, Bern University Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebral Venous Thrombosis, run by Insel Gruppe AG, University Hospital Bern at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00924859, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2018.