- Print the forms and fill out manually. The completed forms have to be faxed to +1-905-521-1551.
- Use a black pen. In each square there should only be one digit or letter.
- Dates are always written as YY/MMM/DD. Three letters are used to indicate the month. Thus, April 03, 2006 is 06APR03.
- There are only 3 forms:
- Registry Form – Center Information
- Registry Form – Inclusion
- Registry Form – 3-month follow-up
- Break-through event: is the episode of deep vein thrombosis (DVT) and/or pulmonary embolism (PE) in a patient while on therapeutic anticoagulant therapy. If there are multiple episodes while on anticoagulant therapy, then the first recurrent episode is the Break-through event.
- Previous venous thromboembolism (VTE) Event: is the last one that occurredbeforethe Break-through Event and should not have occurred while on therapeutic anticoagulation.
- Therapeutic anticoagulant therapy: any kind of heparin, pentasaccharide or vitamin K antagonist at the following doses when the break-through occurred:
- For intravenous unfractionated heparin, the APTT should be at least twice the upper limit of normal.
- For low-molecular-weight heparin (LMWH), the daily dose must be at least 150 IU/kg (or 1.5 mg/kg) during the first week after the previous VTE or on at least 4000 IU (40 mg) daily thereafter. Anti-Xa level is not a criterion.
- For fondaparinux, the daily dose must be 5 mg (<50 kg), 7.5 mg (50 – 100 kg), or 10 mg (>100 kg).
- For vitamin K antagonist, the INR must be 1.8 or higher.
- Cancer: Patients with basal cell skin cancer, myelodysplastic syndrome, myeloproliferative syndrome, or pre-malignant disease (e.g., carcinoma-in-situ) are NOT considered in this registry.
You may register patients who had their Break-through Event on or after July 1, 2005 , as long as you have access to all the data needed, and that this is permitted by your Institutional Review Board/Research Ethics Committee.
A case that is eligible for registration must satisfy ALL 4 of the following criteria:
- An objectively confirmed break-through venous thrombo-embolic event (DVT or PE or both). Note that central or peripheral line thrombosis doesnotqualify for registration.
- Patient has histologically confirmed cancer or is receiving cancer therapy at the time of the break-through event. Diagnosis of cancer must occur prior to the break-through event or no later than 1 week after the break-through event.
- A minimum of 3 months of follow-up information (or up to time of death if that comes earlier) after the breakthrough event must be available.
- Some kind of antithrombotic therapy is given after the break-through event. (Thus, terminal patients, for whom the treatment is withdrawn at this point are not eligible.)
Sample Scenarios for Eligibility:
- The patient with known cancer was onanticoagulant therapy for another indication, e.g. atrial fibrillation and has not had previous VTE. Þ YES, you can register this case. Here there is no "Previous VTE Event”.
- The patient has a second VTE while on therapeutic anticoagulation, but thecancer is only diagnosed one month afterwards. Þ NO, this patient is not eligible. Maximum time allowed for the diagnosis of cancerafterthe Break-through Event is 1 week.
- The patient with known cancer had a previous DVT, was on warfarin, and had arecurrence while the INR was 1.2. Þ NO, this patient is not eligible. The INR must be at least 1.8.
Center Information Form:
- This form is the first one to be completed. You only have to do it once unless the information regarding your center changes.
- This form must be faxed with or before the first case you register.
- The payment details have to exact and as detailed as possible. It is mainly the European countries that have IBAN numbers, but every bank should have a SWIFT code (= Bank Identifier COD, BIC), see:http://www.swift.com/biconline/
- Center No.– You will receive your center number when you fax theCenter Informationpage. If you fax that page together with your first case, leave this blank and we will fax back a receipt with your number. Retain that number for future cases.
- Year of birth– last 2 digits.
- Date of recurrent VTE or Break-through Event– this should be the date of the objective test that confirmed the recurrent VTE event.
- TheRegistry identification numberfor a patient born in 1943 and diagnosed with recurrent DVT/PE on May 1, 2006 at center number 050 is 050-43-06MAY01. Please provide this number on all correspondence for this case.
- Body weight– at the time of the Break-through event. If you have the weight in pounds, divide by 2.2 to obtain kg.
- Creatinine– at the time of the Break-through event. If you have the creatinine in mg/dL, multiply by 88 to obtain ?mol/L
- Cancer Dx– date of histological confirmation.
- Extent– burden of cancer at the time of the Break-through event. For all hematological malignancies not in remission, check the Metastatic box.
- ECOG score– Eastern Cooperative Oncology Group performance status score at the time of the Break-through event:
- 0 Asymptomatic
- 1 Symptomatic, fully ambulatory
- 2 Symptomatic, in bed < 50% of the day
- 3 Symptomatic, in bed > 50% of the day but not bedridden
- 4 Bedridden
- 5 Dead (not eligible)
- Diagnostic method– State all methods that were used, one per box.
- APTT/Anti-Xa level/INR at break-through– The last result before the diagnosisandbefore any bolus dose given due to suspected recurrence.
- IVC filter– inferior vena cava filter in place at the time of the Break-through or Previous VTE Event.
3-Month Follow-Up Form:
- Registry Identification Numberis the same as the combination you filled out at the top of the Inclusion form.
- Treatments given to treat break-through VTE:provide information on all the treatments given after the diagnosis of that event and until 3 months or end of treatment or death, whatever comes first. If the patient had short periods of LMWH or unfractionated heparin of less than 5 days duration, e.g. for a couple of days for bridging of anticoagulation at the time of invasive procedures, this is not necessary to record. It is the main features of the treatment we are interested in.
- Major bleeding complications:(if no such event, check None and proceed to C) indicate the type of major bleeding event as for example GI-bleeding, intracerebral bleeding etc. The bleeding has to fulfill at least one of the criteria according to the ISTH definition below.
- Fatal bleeding, and/or
- Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome, and/or,
- Bleeding causing a fall in hemoglobin level of 20 g/L (1.24 mmol/L) or more, or leading to transfusion of two or more units of whole blood or red cells.
Bleeding events that do not meet the above criteria are not recorded in the form.
- Outcome of break-through VTE:if patient has further recurrent events after the break—through event, indicate the type of event and provide all diagnostic methods used, one per square. If more than 2 events during these 3 months, provide only the first 2 eventsafterthe Break-through Event.
- Most recent status of the patient:The date should be at least 3 months after the date of the Break-through Event, unless death has occurred prior to the end of 3 months.
Faxing the documents:
Always start by faxing the Center Informationform. No cover page is necessary.
When you fax the Inclusion form, please submit also reports from the diagnostic procedures for the break-through VTE and if at all possible also for the last previous event. You should mask or cut out the personal data on the patient.
If there have been recurrent VTE events during the follow-up, please submit in the same way copies of diagnostic reports with the 3-month follow-up form.
Fax to +1-905-521-1551, i.e. at the "+” you have to insert you prefix to dial internationally (applicable to the non-Canadian centers)