Prevention and Prophylaxis of Cancer Associated Thrombosis in High Risk Oncology Patients

• Conditions: Iliac; Thrombosis; Pulmonary Embolism; Vena Cava Thrombosis; Deep Vein Thrombosis

• Registration Number: NCT03909399
• Lead Sponsor: Hellenic Society of Medical Oncology

Brief Summary

Prevention and Prophylaxis (Thromboprophylaxis - ACT) of Cancer Associated Thrombosis (CAT) in High Risk Oncology Patients: ACT4CAT.

Detailed Description

Venous thromboembolism (VTE), which includes both deep venous thrombosis (DVT) and pulmonary embolism (PE), is a highly prevalent complication of malignancy. The development of VTE in cancer patients is associated with several adverse consequences including worsened short- and long-term prognosis and survival, mortality, morbidity, chemotherapy postponement, potential hospitalization, need for long-term anticoagulation with attendant bleeding complications and high rates of recurrent VTE . In addition, VTE leads to significant consumption of health care resources; in one study of cancer patients, the adjusted mean incremental all-cause health care costs of VTE were $30,538 per patient. Therefore, the optimal prevention and treatment of VTE are crucial components of patient care in this population. Currently, Low-Molecular-Weight Heparin (LMWH), is the gold standard for the CAT management for the last 15 years Moreover, in a variety of high-risk thrombosis clinical settings, LMWHs agents are safe and effective in preventing VTE. Multiple randomized trials of thromboprophylaxis have been conducted focusing on ambulatory cancer patients receiving chemotherapy. ESMO and ASCO current guidelines suggest considering thromboprophylaxis in high-risk ambulatory cancer patients with LMWHs. ECOG index, metastatic malignancy, chemotherapy and history of thrombosis were significantly associated with the decision to use thromboprophylaxis in most situations.

Additionally, in 2016 Hellenic Society of Medical Oncology (HeSMO) has conducted the GMaT study to assess the awareness of Thrombosis and highlight the current clinical practice in Greece. The study has precluded adoption of outpatient prophylaxis in largely unselected patients with cancer without significant adverse events. Based on GMaT findings, the investigators will proceed in an observational study focusing on thromboprophylaxis in cancer patients with high thrombotic cancer types. In particular, the title of this new study will be "Prevention and Prophylaxis (Thromboprophylaxis - ACT) of Cancer Associated Thrombosis (CAT) in High Risk Oncology Patients: ACT4CAT".

Study Timeline

• Study Start: 2019-01-25
• Study First Submitted: 2019-04-04
• Study First Submitted QC: 2019-04-08
• Study First Posted: 2019-04-10
• Status Verified: 2020-07
• Last Update Submitted: 2021-02-09
• Last Update Posted: 2021-02-10
• Primary Completion: 2021-03-31
• Study Completion: 2021-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recording all objectively confirmed VTE events for 500 patients during the treatment period	1 YEAR	Recording the rate of symptomatic distal deep vein thrombosis (DVT), symptomatic or incidental proximal DVT (including iliac and vena cava thrombosis), symptomatic or incidental pulmonary embolism (PE) or both DVT and P, will also be recorded the agent, the dose and the duration of the antithrombotic therapy

Trial Locations

Locations (1)

Hellenic Society of Medical Oncology; 🇬🇷 Athens, Greece