Patients with cancer-associated thrombosis and thrombocytopaenia Haematological Disorders
Conditions
Interventions
Randomisation will be by Sealed Envelope, an anonymised online randomisation service.
Study arm without platelet transfusion
Modified dose LMWH
Participants will be given a modified dose LMWH as be
Sponsors
University College London
Eligibility
Sex/Gender
All
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Adult participants (age =18 years) with active malignancy (malignancy diagnosed or treated within the previous 6 months, or progressive/relapsed) 2. Imaging confirmed pulmonary embolism, deep vein thrombosis (proximal or distal, including central venous catheter-related DVT), or unusual site VTE (either symptomatic or incidentally diagnosed) within the last 14 days for which anticoagulation is planned (including VTE in the deep vein system that progressed from a prior superficial vein thrombosis for which anticoagulation is to be started) 3. Platelet count <50 x 10e9/L from cancer therapy or malignancy itself 4. Able to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Receipt of anticoagulant for index VTE with platelet count 72 hours 2. Superficial vein thrombosis only 3. Tumour thrombus 4. Life expectancy <1 month (as judged by the treating physicians) 5. Creatinine clearance < 30 ml/min 6. Contraindication to LMWH such as a history of heparin induced thrombocytopaenia 7. Thrombocytopaenia from other causes, such as thrombotic microangiopathy, immune thrombocytopaenia, disseminated intravascular coagulation 8. Previously documented history of refractoriness to platelet transfusion secondary to HLA antibodies 9. Refusal of blood products 10. Anticoagulation at any dose is deemed unsafe (i.e. recent, active bleeding or inherited bleeding disorders)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary feasibility outcome is the number of participants recruited from all centres per month over 18 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Feasibility: 1. Proportion of eligible participants who provide consent by 18 months 2. Reasons for non-participation in eligible participants by 18 months 3. Proportion of participants who complete study procedures by 18 months 4. Proportion of participants who adhere to the protocol (such as anticoagulation, transfusion, platelet count monitoring according to the protocol) by 18 months 5. Rates of withdrawal, loss to follow-up, or crossover between treatment arms by 18 months Other: 1. Duration of thrombocytopaenia (days of platelet count <25 or 50 x10e9 /L) per participant by day 30 +/- 3 days 2. Number of transfused packed red cells and platelet units – with one red cell unit being one standard UK adult unit of packed red cells with a volume of 220-340 ml and one platelet unit being one standard UK adult platelet dose with a mean of around 3 × 10e11 platelets by day 30 +/- 3 days 3. Feasibility of collection of health-related quality of life data using EuroQoL-EQ-5D-5L questionnaire (% completed) by day 30 +/- 3 days | — |
Countries
England, United Kingdom
Contacts
Public ContactYishi Tan
Outcome results
None listed