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Big data vs. clinical trials: can insurance records match gold-standard results?

NCT ID NCT07599384

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

149,248 people

The number who actually took part.

Started

Oct 2024

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

Patients aged 18 years or older undergoing elective total knee arthroplasty.

Ages

18 years and older

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

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

  • 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.