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CTRI Number  CTRI/2024/10/075910 [Registered on: 25/10/2024] Trial Registered Prospectively
Last Modified On: 04/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To evaluate the effectiveness of Apixaban and Aspirin in preventing blood clots in the portal vein after laparoscopic splenectomy. 
Scientific Title of Study
Modification(s)  		 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. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Saksham Gagal 
Designation  Junior Resident(MS General surgery) 
Affiliation  All Indian Institute of Medical Sciences,New Delhi 
Address  Department of Surgical Disciplines, SURGERY BLOCK, AIIMS New Delhi, Ansari Nagar East

New Delhi
DELHI
110029
India 
Phone  7300046423  
Fax    
Email  sgagal849@aiims.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr. Manjunath Maruti Pol 
Designation  Additional Professor 
Affiliation  All Indian Institute of Medical Sciences,New Delhi 
Address  Department of Surgical Disciplines, SURGERY BLOCK, AIIMS New Delhi, Ansari Nagar East

New Delhi
DELHI
110029
India 
Phone  9990187137  
Fax    
Email  manjunath.pol@aiims.edu  
 
Details of Contact Person
Public Query  
Name  Dr Saksham Gagal 
Designation  Junior Resident(MS General surgery) 
Affiliation  All Indian Institute of Medical Sciences,New Delhi 
Address  Department of Surgical Disciplines, SURGERY BLOCK, AIIMS New Delhi, Ansari Nagar East

New Delhi
DELHI
110029
India 
Phone  7300046423  
Fax    
Email  sgagal849@aiims.edu  
 
Source of Monetary or Material Support  
The cost will be borne by the AIIMS, New Delhi Research Section under an institutional grant. All India Institute Of Medical Science,New Delhi, India, 110029 
 
Primary Sponsor  
Name  All India Institute Of Medical Sciences, New Delhi 
Address  All India Institute Of Medical Sciences, New Delhi Ansari Nagar 110029 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Saksham Gagal  All India Institute Of Medical Sciences New Delhi  Room 416, Department of Surgical Disciplines, SURGERY BLOCK
New Delhi
DELHI 		 7300046423

sgagal849@aiims.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee for Post graduate research,AIIMS New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D788||Other intraoperative and postprocedural complications of the spleen,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  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. 
Comparator Agent  Oral Tablet Aspirin  Standard Treatment plus Tab. Aspirin 75 mg 0D from Post-Operative Day 2 of Laparoscopic Splenectomy for 3 months following Surgery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  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.
 
 
ExclusionCriteria 
Details  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
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Proportion of Patients who develop Portal venous thrombosis after Laparoscopic Splenectomy in Apixaban group vs Aspirin group.  3 Months from the day of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Bleeding with or without requiring transfusion.   3 months from the day of surgery 
Difference in Portal vein velocity post-surgery.  3 months from the day of surgery. 
Postoperative Liver Function-Assessed via liver function tests (LFTs), including ALT, AST, bilirubin, and albumin levels.   3 months from the day of surgery 
Occurrence of other thromboembolic events, such as deep vein thrombosis or pulmonary embolism.  3 months from the day of surgery 
Direct cost analysis between the groups.  3 months from the day of surgery 
Mortality Rate: Deaths occurring within 3 months post-surgery.  3 months from the day of surgery 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   05/11/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Portal vein thrombosis (PVT) is a common and potentially life-threatening complication following a splenectomy. It can lead to liver function damage, intestinal ischemia, portal hypertension, an increased risk of variceal bleeds, cavernoma formation, portal biliopathy, and even death.

The incidence of PVT following post-splenectomy varies widely from 5% to 52% in the literature.The American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL) recommend considering prophylactic anticoagulation in high-risk patients undergoing splenectomy. However, the optimally recognised anticoagulation regimen remains debated to date.

Studies reported that prophylactic anticoagulation in the postoperative period significantly reduced the risk of portal venous thrombosis. Hence, identifying these patients at risk of portal venous thrombosis prior to surgery will help optimize anticoagulation in the postoperative period.

From the available literature, there have been reports of the beneficial role of low molecular weight heparin (LMWH) as a prophylactic anticoagulant in high-risk patients undergoing splenectomy.Studies confirm that, compared with conventional anticoagulants, Apixaban is safer for the general population.Apixaban has not yet been used as a prophylactic agent to prevent PVT after splenectomy. It has been used for the treatment of acute and chronic PVT.

Studies show that Apixaban is as effective as traditional anticoagulants such as LMWH and Warfarin for the treatment of portal vein thrombosis in both cirrhotics and non-cirrhotics, with fewer bleeding complications.Apixaban has a relatively wide therapeutic window, a safety profile, a user-friendly fixed-dose regimen without the need to monitor the PT, with fewer food and drug interactions compared with other anticoagulants, and a reduced cost.There is no randomised control trial in the English literature to compare the efficacy of prophylactic Apixaban compared to Aspirin in post-splenectomy patients with thrombotic risk to prevent PVT. Therefore, a study to find the role of prophylactic use of Apixaban in post-splenectomy patients with the primary endpoint of PVT prevention is warranted.

 
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