Active — Not RecruitingNot Applicable

Replication of the RECORD1 Anticoagulant Trial in Healthcare Claims Data

United States89,215 participantsStarted 2020-09-22

Plain-language summary

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.

Who can participate

Age range

18 Years – 120 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Please see https://drive.google.com/drive/folders/1WD618wrywYjEaXzfLTcuK-VCcnb6b-gV for full code and algorithm definitions. Inclusion Criteria: * At least 18 years of age * Scheduled to undergo elective total hip arthroplasty Exclusion Criteria: * 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 \[Day -180, Day 0\]

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time to first occurrence of deep-vein thrombosis, nonfatal pulmonary embolism, or death from any cause at 36 days

Timeframe: From 1 day after fill until the earliest of outcome occurrence, end of data or study period, death, treatment discontinuation +10-day grace/risk window, nursing home admission, treatment augmentation, switch to other NOAC/Warfarin, assessed up to 36 days

Trial details

NCT IDNCT05083455

SponsorBrigham and Women's Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-06-15

View on ClinicalTrials.gov More Deep Vein Thrombosis, Pulmonary Embolus trials