Comparing blood thinners for people with cirrhosis and portal vein clots
Efficacy and Safety of Anticoagulant Therapy for Portal Vein Thrombosis In Cirrhosis Patients With and Without Hepatocellular Carcinoma
PHASE4 · Mansoura University · NCT07132515
This will try enoxaparin, warfarin, or apixaban in people with cirrhosis and portal vein thrombosis (with or without liver cancer) to see which controls the clot and is safest.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Mansoura University (other) |
| Locations | 1 site (Al Mansurah, Dakahlia Governorate) |
| Trial ID | NCT07132515 on ClinicalTrials.gov |
What this trial studies
Adults with cirrhosis (Child‑Pugh A or B) who have portal vein thrombosis, with or without hepatocellular carcinoma, will receive one of three anticoagulants (enoxaparin, warfarin, or apixaban) and be followed over time. The study will monitor clot resolution, bleeding complications, and other safety outcomes while excluding those with very low platelets, significant renal impairment, Budd‑Chiari syndrome, or uncontrolled active bleeding. As a Phase 4 interventional trial at Mansoura University Hospitals, it compares drugs already in clinical use rather than testing a new agent. Imaging and laboratory follow-up will be used to detect recanalization and adverse events.
Who should consider this trial
Good fit: Ideal candidates are adults with cirrhosis (Child‑Pugh A or B) and portal vein thrombosis, with or without hepatocellular carcinoma, who do not have severe renal failure, extremely low platelets, active uncontrolled bleeding, or Budd‑Chiari syndrome.
Not a fit: Patients with creatinine >1.9 mg/dL, platelets <10,000, uncontrolled active bleeding, or Budd‑Chiari syndrome are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the results could clarify which commonly used blood thinner offers the best balance of clot resolution and safety for patients with cirrhosis and portal vein thrombosis.
How similar studies have performed: Previous studies have shown that anticoagulation can promote recanalization of portal vein thrombosis in cirrhosis and reduce progression, and emerging data suggest direct oral anticoagulants like apixaban may be effective but are less extensively studied than heparins or warfarin.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Portal vein thrombosis, Cirrhosis, With or without HCC, Child A \& B Exclusion Criteria: * Platelets\<10000, Createnine \>1.9, Budd ciarri, Uncontrolled active bleeding
Where this trial is running
Al Mansurah, Dakahlia Governorate
- Mansoura University Hospitals — Al Mansurah, Dakahlia Governorate, Egypt (RECRUITING)
Study contacts
- Study coordinator: Dalia Elsayed Ganady, MBBS
- Email: dalia.tawfik97@gmail.com
- Phone: +201095529264
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cirrhosis, HCC - Hepatocellular Carcinoma, Portal Vein Thrombosis