Incidental Pulmonary Embolism in Cancer Patients
Conditions
Interventions
Trade Name: Fragmin® 5000 IU
Product Name: Dalteparin
Pharmaceutical Form: Solution for injection in pre-filled syringe
INN or Proposed INN: dalteparin Sodium
Concentration type: not less then
Sponsors
Hull & East Yorkshire Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A. i-PE group: 1) Adults =18 years. 2) Active cancer. 3) Incidentally diagnosed with pulmonary embolism. 4) Able to provide written informed consent. 5) Able to complete study assessments 6) LMWH considered as standard care B. prospective recruited control group 1) Adults =18 years. 2) Active cancer. 3) Able to provide written informed consent. 4) Able to complete study assessments. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: 1) No Cancer. 2) No PE. 3) Other thrombosis without concurrent PE (deep vein thrombosis (DVT), splanchnic VTE) 4)Anticoagulation contraindications. a) Brain metastasis. b) Platelets = 50x 10 log 9/l c) Known bleeding tumour with active bleeding, eg: - Bladder tumour with haematuria - Lung tumour with haemoptysis - Gastric tumour with hematemesis 5) Allergy reaction/ previous side effects of heparin (heparin-induced thrombocytopenia [HIT]) 6) Patients already on warfarin or already anticoagulated with LMWH 7) Recent brain surgery within 6 months. 8) Vascular surgery within 6 months 9) Other arterial event (without concurrent PE)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Do patients with i-PE conventionally treated with anti-coagulation live for a shorter time than matched patients without an I-PE? ;Secondary Objective: • What is the impact of the symptom burden on survival and on other clinically significant events (e.g hospitalisation). • Are there subgroups of patients with low risk of PE (or VTE) recurrence or patients with a high risk of recurrence, and could these have survival implications? • What is the impact of the treatment on the QoL of these patients? • Is there any predictive value of particular prothrombotic markers of the malignancy (TF, PAR2 and thrombin generation) for occurrence of i-PE (or more broadly VTE) and survival? ;Primary end point(s): The primary outcome measure for the study is patient survival at 6 months, i.e. the number of patients still alive after 6 months. Data will be analysed as intention to treat. The SPSS computer package will be used with a p-value of <0.05 taken as the level of significance. In terms of survival analysis, this will be measured from the first diagnosis of the tumour stage within which the i-PE occurred, rather than from the event itself, so as to avoid lead time bias. ;Timepoint(s) of evaluation of this end point: This end point will be evaluated at the end of the study, allowing for a 6-month follow-up of the last patient recruited. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary outcome measures will be quality of life and symptom burden, as determined using the questionnaires, and their relative impact on survival. Performance status and its relation to survival will be another key measure. Other clinically significant events will also be measured: number of patients experiencing recurrence of PE/VTE; cancer progression or recurrence; adverse events from LMWH treatment; and 30-day post-commencement of LMWH hospitalisation, as well as the number of days spent in hospital and the mortality rate. Laboratory analyses will provide specific measures of levels of key coagulation biomarkers in blood and tissue samples of participants. ;Timepoint(s) of evaluation of this end point: Cancer patients enrolled in the study will be evaluated on a regular basis; following the baseline visit, Visit 1 will be 7 days from the start of treatment; Visit 2 will be after 30 days (+/- 3 days); Visit 3 will be after 60 days (+/- 3 days); Visit 4 will be after 90 days (+/- 3 days); and Visit 5 will be after 180 days (+/- 3 days). In each visit patients will be asked to give a blood sample for laboratory analysis and to fill in the Quality of Life and symptom questionnaires. The control patients will give no further blood samples after the baseline visit, but will be asked to complete the QoL and symptom questionnaires at the baseline visit, baseline +90 days and baseline + 180 days timepoints. | — |
Countries
United Kingdom
Contacts
Public ContactProfessor Anthony Maraveyas
Hull & East Yorkshire Hospitals NHS Trust
Outcome results
None listed