Emulation of the RECORD3 Trial Using Healthcare Claims Data

Completed

Conditions studied: Deep Vein Thrombosis, Pulmonary Embolus

In brief

Investigators are building an empirical evidence base for real-world data through large-scale replication of randomized controlled trials. The investigators' goal is to understand for what types of clinical questions real-world data analyses can be conducted with confidence and how to implement such studies.

Key facts

Study ID

NCT07599384

Run by

Brigham and Women's Hospital

People needed

149248

Starts

2024-10-13

Expected to finish

2026-06-15

Last updated by the study team

2026-07-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 18 years of age
• Scheduled to undergo elective total knee replacement

You may not qualify if…

• Pregnancy or breastfeeding
• Had active bleeding or high risk of bleeding
• Had contraindications for prophylaxis with enoxaparin
• Drug or alcohol abuse
• Concomitant use of protease inhibitors for the treatment of HIV
• Had planned intermittent pneumatic compression
• Had a requirement for anticoagulant therapy that could not be stopped
• Substantial liver disease
• Severe renal impairment (creatinine clearance <30 ml per minute)
• Concurrent use of both drugs

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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