Could a Once-Daily pill replace needles for kids with blood clots?
NCT ID NCT07618988
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether the blood thinner pill rivaroxaban works as well as standard injections (enoxaparin) in children aged 6 months to 18 years with deep vein clots. Sixty children were randomly assigned to either the pill or injections for 3 months. The main goal was to see how well the clots cleared up on repeat imaging.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- rivaroxaban
- What this could lead to
- If successful, this could offer a simpler oral treatment option for children with deep vein clots, potentially replacing daily injections.
- What could go wrong
- This is a small, single-center trial with only 60 children, so results may not apply broadly. Bleeding risk remains a concern with any blood thinner.
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.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
60 people
The number who actually took part.
- Started
-
Aug 2024
- Finished
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May 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.
- Ages
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6 months to 18 years
- 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: 1. Patients from 6 months to less than 18 years of age. 2. Patients with acute deep venous thrombosis diagnosed based on site-appropriate imaging tools e.g., magnetic resonance venography (MRV) in Cerebral sinus venous thrombosis (CSVT), venous duplex in Central Venous Access Devices (CVAD) related thrombosis or other non-CSVT DVT. 3. Patients with cancer associated thrombosis are eligible. 4. Patients with provoked or unprovoked acute VT are eligible. 5. Patients with first thrombotic event or recurrent VT are eligible. Exclusion Criteria: 1. Patients with active bleeding 2. High-risk of bleeding including: * Platelet count of less than 50 x 109/L, * Liver disease associated either a coagulopathy leading to a clinically relevant bleeding risk, or ALT \> 5× ULN. * Sustained uncontrolled hypertension defined as systolic and/or diastolic blood pressure \> 95th age percentile. 3. Severe renal impairment (Estimated glomerular filtration rate \< 30 mL/min/1.73m2). 4. Gastrointestinal disease associated with impaired absorption. 5. Hypersensitivity or any other contraindication listed in the local labelling for Rivaroxaban or comparator treatment. 6. Patients with rheumatic heart disease or prosthetic heart valves.
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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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Ain Shams University Children's Hospital
Cairo, 11566, Egypt