Big data vs. clinical trials: can insurance records match gold-standard results?
NCT ID NCT07599384
First seen Jun 27, 2026 · Last updated Jul 10, 2026 · Updated 1 time
Summary
This study looks at health records of nearly 150,000 people who had knee replacement surgery to see if real-world data can reproduce the findings of a previous clinical trial (RECORD3). The researchers compare two blood thinners, rivaroxaban and enoxaparin, to see which better prevents blood clots. The goal is not to test a new drug, but to learn whether large databases can reliably mimic controlled trials.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- What this could lead to
- If successful, this could show that analyzing large healthcare databases can reliably reproduce results from controlled trials, potentially speeding up medical research.
- What could go wrong
- This is an observational study using existing data, not a new treatment test. Results may not perfectly match the original trial due to differences in patient populations or data quality.
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
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149,248 people
The number who actually took part.
- Started
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Oct 2024
- Finished
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Jun 2026
- Lead sponsor
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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
Patients aged 18 years or older undergoing elective total knee arthroplasty.
- Ages
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18 years and older
- Sex
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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.
Inclusion Criteria: * At least 18 years of age * Scheduled to undergo elective total knee replacement Exclusion Criteria: * 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
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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
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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.
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- New fingerstick test for blood thinner monitoring put to the test
- Can insurance records replace clinical trials? huge study puts it to the test