Study identification

EU PAS number

EUPAS1000000578

Study ID

1000000578

Official title and acronym

Real-world Study on Bemiparin Effect in Patients with Cancer-Associated Thromboembolism Using Artificial Intelligence (BEMICAT Study)

DARWIN EU® study

No

Study countries

Spain

Study description

BEMICAT is a multicenter, retrospective, non-interventional study designed to evaluate the effectiveness and safety of bemiparin compared with other low molecular weight heparins (LMWHs)—dalteparin, enoxaparin, and tinzaparin—in the management of cancer-associated thrombosis (CAT).
CAT, which typically presents as deep vein thrombosis (DVT) or pulmonary embolism (PE), remains a leading cause of morbidity and mortality in cancer patients despite being preventable.

The study emulates a target trial and uses real-world data from electronic health records (EHRs) of Spanish hospitals, leveraging natural language processing (NLP) and machine learning (ML) technologies (EHRead®) to extract structured information from unstructured clinical texts. Data will be collected from 2014 to 2025 and analyzed in two sequential phases.
Phase I is a feasibility assessment;
Phase II, contingent upon Phase I success, will estimate the per-protocol effects of long-term, full-dose anticoagulation with bemiparin versus pooled comparators.
Adult cancer patients with objectively confirmed acute DVT or PE will be included if they initiated anticoagulation with LMWHs within a defined time frame.
Key outcomes include recurrence of venous thromboembolism and major bleeding over a 7-month follow-up. Secondary outcomes include patient characteristics, treatment pathways, time-to-event analyses, and validation of NLP-based data definitions.
This study addresses a major gap in the comparative evidence on bemiparin use in CAT and will provide real-world evidence to inform clinical practice and support regulatory decisions.

Study status

Ongoing
Research institutions and networks

Institutions

LABORATORIOS FARMACÉUTICOS ROVI, S.A.

Contact details

Alicia Lorenzo 0000-0001-7127-8868

Primary lead investigator
ORCID number:
0000-0001-7127-8868

Study timelines

Date when funding contract was signed

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Study start date

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Data analysis start date

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Date of interim report, if expected

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Date of final study report

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Sources of funding
Pharmaceutical company and other private sector 
Regulatory

Was the study required by a regulatory body?

No

Is the study required by a Risk Management Plan (RMP)?

Not applicable