Role of (LMWH) in Prevention of Thromboembolic Complication After (TACE) in Hepatocellular Carcinoma.

NCT02715492 | Unknown Phase 3 DMC

• 1 other identifier: LMWH TACE
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Hepatocellular carcinoma (HCC) is a major health problem worldwide, and most cases are inoperable because of late presentation and underlying cirrhosis. It represents the fifth most common tumor in the world and the third most frequent cause of mortality amongst patients with cancer. Due to the worldwide difficulties in finding liver for transplantation, hepatic resection (HR) represents the main stay of curative treatment for patients with HCC. Transcatheter arterial chemoembolization (TACE) is widely used as alternative treatments for unresectable HCC or for patients not eligible to be operated on . TACE also could be an adjuvant therapy for resectable HCC patients after hepatectomy, which could prevent recurrence and improve long-term survival .

Conditions

HCC

Outcome Measures

Primary Outcomes (1)

• Number of patients with portal vein thrombosis

  3 months

Study Arms (2)

Transarterial Chemoembolization

ACTIVE COMPARATOR

1st group: included 20 patients with HCC treated by TACE only.

Procedure: TACE

TACE and LMWH

EXPERIMENTAL

2nd group: included 20 patients with HCC treated by TACE and adjuvant dose of Low Molecular Weight Heparins (LMWH).

Drug: LMWH; Procedure: TACE

Interventions

LMWH DRUG

(Enoxheparin) 1 IU/kg per dose twice daily for 2 weeks from the 1st day of TACE

Also known as: Enoxaparin

TACE and LMWH

TACE PROCEDURE

Trans arterial chemoembolization

TACE and LMWH; Transarterial Chemoembolization

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• HCC which was not amenable to surgical resection, liver transplantation or local ablative therapy.
• The lesion had not been previously treated with surgery, radiation therapy, radiofrequency ablation, percutaneous ethanol or acetic acid injection, or cryoablation.
• Reasonable performance status as adequate hematologic function; adequate hepatic function and adequate renal function.
• Child-Pugh class A or B and no portal vein thrombosis.

You may not qualify if:

• Child C patients Portal vein thrombosis

Sponsors & Collaborators

• Sherief Abd-Elsalam: lead

Study Sites (1)

Tanta university - faculty of medicine

Tanta, Egypt

Location

MeSH Terms

Interventions

Heparin, Low-Molecular-Weight; Enoxaparin

Intervention Hierarchy (Ancestors)

Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Officials

• Osama Negm, Prof

  Prof. liver diseases-Tanta university

  PRINCIPAL INVESTIGATOR

• Sabry Abou Saif, Ass. Prof.

  Ass/ Prof. liver diseases-Tanta university

  STUDY CHAIR

• Mohamed El Gharib, Ass. Prof.

  Ass. Prof. interventional radiology - Ain-shams university

  STUDY DIRECTOR

• Sherief Abd-Elsalam, Lecturer

  MD liver diseases - Tanta university

  STUDY DIRECTOR

Central Study Contacts

Sherief Abd-Elsalam, Lecturer

CONTACT

00201095159522; Sheriefabdelsalam@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD liver diseases

Study Record Dates

• First Submitted: March 17, 2016
• First Posted: March 22, 2016
• Study Start: October 1, 2018
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: December 27, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)