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EXCOA-CVT STUDY - INCLUSION FORM
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INVESTIGATOR DETAILS
Investigator Name *
Investigator ID Code
If you do not remember your "Investigator ID code", you will be contacted by email to confirm that you submitted this form.
Investigator Email *
HOSPITAL/MEDICAL CENTER
CITY
COUNTRY
PHONE/FAX
PATIENT IDENTIFICATION
Patient Hospital Number
Date of Birth
MM
/
DD
/
YYYY
Age
(in years)
Gender
Clear selection
DIAGNOSIS OF CEREBRAL VEIN THROMBOSIS
DATE OF ONSET OF SYMPTOMS
MM
/
DD
/
YYYY
DATE OF CONFIRMATION OF CVT DIAGNOSIS BY IMAGING
MM
/
DD
/
YYYY
Diagnosis CONFIRMED BY:
NEUROIMAGING DETAILS (at admission)
Were any of these imaging techniques performed?
YES
NO
CT scan
MRI scan
Clear selection
Any PARENCHYMAL LESION?
Clear selection
If there were parenchymal lesions, please specify
CEREBRAL SINUSES INVOLVED
Please select CEREBRAL SINUSES/VEINS INVOLVED:
This should include sinuses occluded on angiography or thrombus visible on MRI
PRESENTING SYMPTOMS/SIGNS
This should include details from onset of symptoms until the date of diagnosis.
MODE OF ONSET:
Clear selection
SYMPTOMS/SIGNS:
(you can select more than one)
THROMBOPHILIA TESTING
POSITIVE
NEGATIVE
NOT PERFORMED
AWAITING RESULTS
LUPUS ANTICOAGULANT
ANTIPHOSPHOLIPID ANTIBODIES
PROTEIN C DEFICIENCY
PROTEIN S DEFICIENCY
ANTITHROMBIN DEFICIENCY
FACTOR V LEIDEN MUTATION
PROTHROMBIN G20210A MUTATION
ELEVATED HOMOCYSTEINE PLASMA LEVELS
ELEVATED FACTOR VIII
Clear selection
RISK FACTORS / ASSOCIATED CONDITIONS
PAST HISTORY of thromboembolic events?
(you can select more than one event type)
TRANSIENT RISK FACTOR(S)?
Please consider only transient those present up to 3 months before the CVT event
Please provide more specific DETAILS about the TRANSIENT RISK FACTOR(s) selected above:
(e.g. type of surgery / location of infection / type of mechanical precipitant / thrombotic drug)
PERMANENT RISK FACTOR(S)?
Please consider permanent those present for at least 6 months before the CVT event
Please provide more specific DETAILS about the PERMANENT RISK FACTOR(s) selected above:
(e.g. type of acquired thrombophilia / malignancy type / type of vasculitis / specify other inflammatory prothrombotic condition)
TREATMENT IN THE ACUTE PHASE
You can select more than one treatment, when appropriate.
Please provide START DATE and END DATE for any of the treatment options selected.
YES
NO
INTRAVENOUS HEPARIN
Clear selection
START DATE of intravenous heparin:
MM
/
DD
/
YYYY
END DATE of intravenous heparin:
MM
/
DD
/
YYYY
YES
NO
LOW MOLECULAR WEIGHT HEPARIN
Clear selection
START DATE of low molecular weight heparin:
MM
/
DD
/
YYYY
END DATE of low molecular weight heparin:
MM
/
DD
/
YYYY
YES
NO
SYSTEMIC INTRAVENOUS FIBRINOLYTICS
Clear selection
START DATE of systemic intravenous fibrinolytics:
MM
/
DD
/
YYYY
END DATE of systemic intravenous fibrinolytics:
MM
/
DD
/
YYYY
YES
NO
LOCAL INTRAVENOUS FIBRINOLYTICS
Clear selection
START DATE of local intravenous fibrinolytics:
MM
/
DD
/
YYYY
END DATE of local intravenous fibrinolytics:
MM
/
DD
/
YYYY
YES
NO
OTHER ENDOVASCULAR INTERVENTION
Clear selection
DATE of endovascular intervention:
MM
/
DD
/
YYYY
SPECIFY the TYPE of endovascular intervention performed:
YES
NO
HEMATOMA EVACUATION
Clear selection
DATE of hematoma evacuation:
MM
/
DD
/
YYYY
YES
NO
DECOMPRESSIVE CRANIECTOMY
Clear selection
DATE of decompressive craniotomy:
MM
/
DD
/
YYYY
YES
NO
THERAPEUTIC LUMBAR PUNCTURE
Clear selection
DATE of therapeutic lumbar puncture:
MM
/
DD
/
YYYY
YES
NO
ANTI-EPILEPTIC DRUGS
Clear selection
START DATE of anti-epileptic drugs:
MM
/
DD
/
YYYY
END DATE of anti-epileptic drugs:
MM
/
DD
/
YYYY
OTHER TREATMENTS USED:
(you can select more than one)
CLINICAL EVENTS DURING HOSPITALIZATION
Please provide details of events that occurred ONLY during hospitalisation and CONFIRMED by appropriate means of investigation.
YES
NO
RECURRENT CVT
Clear selection
DATE of CVT recurrence:
MM
/
DD
/
YYYY
If there were NEW PARENCHYMAL LESIONS, please specify:
YES
NO
NEW NON-HEMORRHAGIC LESION (focal cerebral edema / venous infarction)
NEW HEMORRHAGIC LESION (hemorrhagic infarction / intracerebral hematoma)
Clear selection
YES
NO
Lower limbs DVT
Clear selection
DATE of lower limb DVT
MM
/
DD
/
YYYY
YES
NO
Pelvic DVT
Clear selection
DATE of pelvic DVT
MM
/
DD
/
YYYY
YES
NO
Upper limbs DVT
Clear selection
DATE of upper limbs DVT
MM
/
DD
/
YYYY
YES
NO
Pulmonary embolism
Clear selection
DATE of pulmonary embolism
MM
/
DD
/
YYYY
YES
NO
OTHER TYPE OF VENOUS THROMBOEMBOLIC EVENT
Clear selection
DATE of other venous thromboembolic event:
MM
/
DD
/
YYYY
If other venous thromboembolic event, please SPECIFY:
If other MORE THAN ONE venous thromboembolic events, please provide SEQUENCE, DATE and TYPE:
e.g. 1- Lower limb DVT(dd/mm/yyyy); 2- Pulmonary embolism (dd/mm/yyyy)
YES
NO
New seizure?
Clear selection
DATE of new seizure:
MM
/
DD
/
YYYY
MODIFIED RANKIN SCALE
MODIFIED RANKIN SCALE
EXCOA-CVT INFORMATION
Does the patient fulfil EXCOA-CVT INCLUSION CRITERIA? *
YES
NO
Patients with acute symptomatic and confirmed CVT
Age >= 18 years at entry
CVT diagnosed in < 1 month
Patient clinically stable, able to stop any form of parental anticoagulation in order to start oral anticoagulation
Written informed consent
Does the patient have any EXCOA-CVT EXCLUSION CRITERIA? *
YES
NO
Systemic life-threatening or major bleeding while on anticoagulants during the acute phase of CVT or during the 6 months prior to randomisation (intracranial bleeding due to inclusion CVT is not an exclusion criteria)
General contraindications for anticoagulant therapy
Need for prolonged treatment with antiplatelet drugs, non-steroidal anti-inflammatory drugs or other drugs/diseases that interferes significantly with anticoagulant therapy or with INR 
Life expectancy < 2 years due to a pre-existing condition (including any malignancy)
Child bearing potential without adequate contraceptive measures, pregnancy or breast feeding
Known allergy to study medications
Other conditions judged by the investigator to be an absolute indication for prolonged oral anticoagulation such as recurrent CVT, VTE after CVT or first CVT with antiphospholipid syndrome or known severe thrombophilia (antithrombin, protein C or protein S deficiency, homozygous factor V Leiden or prothrombin G20210A mutation or combined abnormalities)
If patient ELIGIBLE for EXCOA-CVT study, please select the ALLOCATED ANTICOAGULATION OPTION:
Clear selection
If patient ELIGIBLE for EXCOA-CVT study please provide DATE OF INITIATION OF POST-ACUTE ANTICOAGULATION TREATMENT:
MM
/
DD
/
YYYY
If patient ELIGIBLE for EXCOA-CVT study please select TYPE OF ANTICOAGULANT:
If patient NOT ELIGIBLE for EXCOA-CVT study, please provide DATE OF INITIATION OF POST-ACUTE TREAMENT:
MM
/
DD
/
YYYY
If patient NOT ELIGIBLE for EXCOA-CVT study, please select TYPE OF POST-ACUTE TREAMENT:
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