Replication of the RECORD1 Anticoagulant Trial in 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

NCT05083455

Run by

Brigham and Women's Hospital

People needed

89215

Starts

2020-09-22

Expected to finish

2026-06-15

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• At least 18 years of age
• Scheduled to undergo elective total hip arthroplasty

You may not qualify if…

• Scheduled to undergo staged, bilateral hip arthroplasty [Day -30, Day 0]
• Pregnany or breastfeeding [Day -180, Day 0]
• Had active bleeding or high risk of bleeding [Day -180, Day 0]
• Had conditions preventing bilateral venography [Day -30, Day 0]
• Congestive heart failure [Day -180, Day 0]
• Pulmonary hypertension [Day -180, Day 0]
• Edema of legs [Day -180, Day 0]
• Substantial liver disease [Day -180, Day 0]
• Severe renal impairment (creatinine clearance <30 ml per minute) [Day -180, Day 0]
• Concomitant use of protease inhibitors for the treatment of HIV [Day -180, Day 0]

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.