Back to results

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

Primary Purpose

HCC

Status

Unknown status

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

LMWH

TACE

About this trial

This is an interventional prevention trial for HCC

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

Child C patients Portal vein thrombosis

Sites / Locations

Tanta university - faculty of medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Transarterial Chemoembolization

TACE and LMWH

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of patients with portal vein thrombosis

Secondary Outcome Measures

Full Information

NCT ID

NCT02715492

First Posted

March 17, 2016

Last Updated

December 22, 2017

Sponsor

Sherief Abd-Elsalam

1. Study Identification

Unique Protocol Identification Number

NCT02715492

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Unknown status

Study Start Date

October 2018 (Anticipated)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Sherief Abd-Elsalam

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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 .

Detailed Description

Thromboembolism is a well-recognised complication of malignant disease. Clinical manifestations vary from venous thromboembolism to disseminated intravascular coagulation and arterial embolism. Disseminated intravascular coagulation is most commonly observed in patients with haematological malignant disorders and those with wide spread metastatic cancer, whereas arterial embolism is most commonly observed in patients undergoing chemotherapy and in those with non-bacterial thrombotic endocarditis . The goals of using antithrombotic therapy with TACE in HCC are to minimize mortality and to improve survival rate without provoking excessive bleeding.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HCC

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Transarterial Chemoembolization

Arm Type

Active Comparator

Arm Description

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

Arm Title

TACE and LMWH

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

LMWH

Other Intervention Name(s)

Enoxaparin

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

TACE

Intervention Description

Trans arterial chemoembolization

Primary Outcome Measure Information:

Title

Number of patients with portal vein thrombosis

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: Child C patients Portal vein thrombosis

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sherief Abd-Elsalam, Lecturer

Phone

00201095159522

Sheriefabdelsalam@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Osama Negm, Prof

Organizational Affiliation

Prof. liver diseases-Tanta university

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Sabry Abou Saif, Ass. Prof.

Organizational Affiliation

Ass/ Prof. liver diseases-Tanta university

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Mohamed El Gharib, Ass. Prof.

Organizational Affiliation

Ass. Prof. interventional radiology - Ain-shams university

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Sherief Abd-Elsalam, Lecturer

Organizational Affiliation

MD liver diseases - Tanta university

Official's Role

Study Director

Facility Information:

Facility Name

Tanta university - faculty of medicine

City

Tanta

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

We'll reach out to this number within 24 hrs