To evaluate the effectiveness of Apixaban and Aspirin in preventing blood clots in the portal vein after laparoscopic splenectomy.

Efficacy of Prophylactic use of Apixaban vs Aspirin Following Laparoscopic Splenectomy in Patients with risk of Portal Vein thrombosis: A Phase 2 Randomised Control Trial. - NIL

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/10/075910

Enrollment

Registered

2024-10-25

Start date

Unknown

Completion date

Unknown

Last updated

2024-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D788- Other intraoperative and postprocedural complications of the spleen

Interventions

Intervention1: Oral Tablet Apixaban: Standard Treatment plus Tab. Apixaban 2.5 mg BD from Post Operative Day 2 of Laparoscopic Splenectomy for 3 months following Surgery. Control Intervention1: Oral T

Eligibility

Inclusion criteria

Inclusion criteria: It is indicated for laparoscopic splenectomy. Any of the Risk Factors of Portal Venous Thrombosis in Splenomegaly that is Pre-operative Portal Vein diameter greater than 10 mm. Post-splenectomy Splenic weight greater than 1000 gm Spleen span on USG is more than 15 cm Willing to provide informed consent.

Exclusion criteria

Exclusion criteria: Refusal to consent Evidence of PVT prior to the surgery. Known thrombophilia. Chronic kidney disease (creatinine clearance less than 30 mL/min). Chronic liver disease, or cirrhotic liver,. Recent use of other anticoagulants or thrombolytics. Active peptic ulcer disease. History of major bleeding events or bleeding disorders. Active or recent gastrointestinal bleeding. Pregnant or breastfeeding women. Concurrent use of medications contraindicated with apixaban. Non-compliance to medicine during follow-up Allergic to Apixaban/Aspirin. Cognitive impairment or psychiatric illness

Design outcomes

Primary

Measure	Time frame
Proportion of Patients who develop Portal venous thrombosis after Laparoscopic Splenectomy in Apixaban group vs Aspirin group.Timepoint: 3 Months from the day of surgery	—

Secondary

Measure	Time frame
Bleeding with or without requiring transfusion.Timepoint: 3 months from the day of surgery;Difference in Portal vein velocity post-surgery.Timepoint: 3 months from the day of surgery.;Postoperative Liver Function-Assessed via liver function tests (LFTs), including ALT, AST, bilirubin, and albumin levels.Timepoint: 3 months from the day of surgery;Occurrence of other thromboembolic events, such as deep vein thrombosis or pulmonary embolism.Timepoint: 3 months from the day of surgery;Direct cost analysis between the groups.Timepoint: 3 months from the day of surgery;Mortality Rate: Deaths occurring within 3 months post-surgery.Timepoint: 3 months from the day of surgery	—

Measure

Time frame

Bleeding with or without requiring transfusion.Timepoint: 3 months from the day of surgery;Difference in Portal vein velocity post-surgery.Timepoint: 3 months from the day of surgery.;Postoperative Liver Function-Assessed via liver function tests (LFTs), including ALT, AST, bilirubin, and albumin levels.Timepoint: 3 months from the day of surgery;Occurrence of other thromboembolic events, such as deep vein thrombosis or pulmonary embolism.Timepoint: 3 months from the day of surgery;Direct cost analysis between the groups.Timepoint: 3 months from the day of surgery;Mortality Rate: Deaths occurring within 3 months post-surgery.Timepoint: 3 months from the day of surgery

—

Countries

India

Contacts

Public ContactDr Saksham Gagal

All Indian Institute of Medical Sciences,New Delhi

manjunath.pol@aiims.edu9990187137

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026