Study identification

EU PAS number

EUPAS43864

Study ID

48855

Official title and acronym

Effectiveness and Safety of Enoxaparin: Higher versus Standard Dose for Thromboprophylaxis in Patients of Varying Body Mass Index – A Retrospective Observational Cohort Study Using Real World EHR and Claims Data

DARWIN EU® study

No

Study countries

Finland

Study description

Obesity is associated with an increased risk of venous thromboembolism (VTE) events. Hospitalized patients have an 8-fold increased risk of VTE, where obesity, surgery and medical acute illness are important, contributing factors. The risk of VTE is also increased among patients undergoing bariatric and non-bariatric surgeries. While enoxaparin is a common therapy for VTE prophylaxis among medically ill and surgical patients, the understanding of an appropriate dosing and duration of the therapy for obese patients is limited. This is an observational, retrospective, cohort study in Finland including patients hospitalized with an acute medical illness or undergoing bariatric or non-bariatric surgery, receiving enoxaparin treatment for VTE prophylaxis from 1 May 2008 to 31 December 2020. The primary objective is to evaluate the impact of higher as compared with standard daily dose of enoxaparin on the risk of VTE and major bleeding events (MBE) at 3-months (primary effectiveness and safety endpoints) in hospitalized medically ill patients and in surgical patients (bariatric and non-bariatric settings). The impact will be analyzed for varying categories of BMI, including obese patients. The secondary objective 1 is to evaluate the impact of higher as compared with standard daily dose of enoxaparin on the risk of VTE and MBE among obese patients, in strata of patient and treatment characteristics: medical or surgical setting, age, sex, history of VTE, history of MBE, treatment duration of enoxaparin prophylaxis, enoxaparin dosing schedule, and surgery type (for surgical patients only). The secondary objective 2 is to evaluate the impact of daily dose of enoxaparin in combination with pre-specified patients and treatment characteristics by using cluster analysis, on the risk of VTE and MBE, separately in hospitalized medically ill and surgical patients.

Study status

Ongoing
Research institutions and networks

Institutions

IQVIA
United Kingdom
First published:
22/04/2024
Institution Non-Pharmaceutical company ENCePP partner

Contact details

Arnaud Mickael

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Sanofi
Regulatory

Was the study required by a regulatory body?

No

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

Not applicable