Can insurance records replace clinical trials? huge study puts it to the test
NCT ID NCT05083455
First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 2 times
Summary
This study is not testing a new treatment. Instead, researchers are checking whether information from healthcare claims (like insurance records) can produce the same results as a famous clinical trial called RECORD1. They are looking at data from over 89,000 people who had hip replacement surgery to see if blood thinners work as expected. The goal is to learn when real-world data can be trusted for future research.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
89,215 people
The number who actually took part.
- Started
-
Sep 2020
- Finished
-
Jun 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
This study will involve a new user, parallel group, propensity score-matched, retrospective cohort study design comparing rivaroxaban to enoxaparin users. The patients will be required to have continuous enrollment during a baseline period of 180 days before initiation of rivaroxaban or enoxaparin (index date). We will restrict the analyses to patients who underwent a total hip arthroplasty.
- Ages
-
18 to 120 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 \[Day -180, Day 0\]
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Deep vein thrombosis, pulmonary embolus are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Brigham and Women's Hospital
Boston, Massachusetts, 02120, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.