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Comparison of Thromboembolic Events in Patients Undergoing Thromboprophylactic Treatment With ENOXA® vs Lovenox® (ENOXACARE)

Primary Purpose

Gastrointestinal Neoplasms, Thromboembolic Event

Status

Completed

Phase

Phase 4

Locations

Tunisia

Study Type

Interventional

Intervention

Enoxaparin 4000 IU

About this trial

This is an interventional prevention trial for Gastrointestinal Neoplasms focused on measuring Enoxaparin, Immunogenicity

Eligibility Criteria

19 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female over 18 years
Gastrointestinal (GI) Cancer
Elective or emergency surgery
Preventive administration of enoxaparin sodium

Exclusion Criteria:

Patients participating in another study
Unfractionated heparin (UFH) use up to 30 days prior to surgical procedure
Renal failure with creatinine clearance <30 ml / min
Known history of peripheral venous thrombosis and/or deep venous thrombosis in the 3 months prior to inclusion
Pregnant or breastfeeding women or women of childbearing age not using medically accepted contraceptive method
Anticoagulant use in the 3 months prior to inclusion
Patients with known haemostatic disorder
Patients not consenting to participate in the study, or not capable of understanding its objectives

Sites / Locations

Charles Nicolle Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ENOXA® group

LOVENOX® group

Arm Description

Patients under ENOXA® 4000 IU according to randomization: Administer ENOXA® 4000 IU (Enoxaparin 4000 IU) per day, regardless of the patient's weight at inclusion Start injections 12 hours after the surgical procedure Administer ENOXA® subcutaneously The administration of ENOXA® should be at the same time on a daily basis for 30 successive days as per the american and french clinical guidelines

Patients under LOVENOX® 4000 IU according to randomization: Administer LOVENOX® 4000 IU (Enoxaparin 4000 IU) per day, regardless of the patient's weight at inclusion Start injections 12 hours after the surgical procedure Administer LOVENOX® subcutaneously The administration of LOVENOX® should be at the same time on a daily basis for 30 successive days as per the american and french clinical guidelines

Outcomes

Primary Outcome Measures

Incidence of asymptomatic Deep Venous Thrombosis (DVT)

To compare the incidence of asymptomatic DVT, assessed by Echo Doppler of the lower limbs, between the two study treatment arms

Secondary Outcome Measures

Incidence of symptomatic thromboembolic events

Compare the incidence of symptomatic DVT and pulmonary embolism (PE) between the two study treatment arms

Number of adverse events

To compare the safety of both the study of products

Incidence of both Enoxaparin formulations immunogenicity

To compare the levels of platelet factor 4 (PF4)-Heparin complex antibodies an platelet count between the two study treatment arms

Full Information

NCT ID

NCT02444572

First Posted

May 7, 2015

Last Updated

July 27, 2021

Sponsor

Les Laboratoires des Médicaments Stériles

1. Study Identification

Unique Protocol Identification Number

NCT02444572

Brief Title

Comparison of Thromboembolic Events in Patients Undergoing Thromboprophylactic Treatment With ENOXA® vs Lovenox®

Acronym

ENOXACARE

Official Title

Comparison of Thromboembolic Events in Patients Undergoing Gastrointestinal Cancer Surgery and Thromboprophylactic Treatment With Two Enoxaparin Formulations (ENOXA® vs Lovenox®)

Study Type

Interventional

2. Study Status

Record Verification Date

July 2021

Overall Recruitment Status

Completed

Study Start Date

October 2015 (Actual)

Primary Completion Date

July 2020 (Actual)

Study Completion Date

July 10, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Les Laboratoires des Médicaments Stériles

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Prospective, monocentric, randomized, parallel group, rater-blinded study using two formulations of Enoxaparin sodium (ENOXA® vs LOVENOX®) to compare the thromboembolic events (symptomatic and asymptomatic) in patients undergoing gastrointestinal cancer surgery and thromboprophylactic treatment with either Enoxaparin formulations. The study has a secondary focus as to evaluate the immunogenicity of the two formulations of Enoxaparin through a subgroup analysis. Study followup duration is up to 30 days post surgical procedure.

6. Conditions and Keywords

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

Gastrointestinal Neoplasms, Thromboembolic Event

Keywords

Enoxaparin, Immunogenicity

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

168 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ENOXA® group

Arm Type

Experimental

Arm Description

Arm Title

LOVENOX® group

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Enoxaparin 4000 IU

Other Intervention Name(s)

ENOXA®, LOVENOX®

Primary Outcome Measure Information:

Title

Incidence of asymptomatic Deep Venous Thrombosis (DVT)

Description

To compare the incidence of asymptomatic DVT, assessed by Echo Doppler of the lower limbs, between the two study treatment arms

Time Frame

7 - 10 days postoperative

Secondary Outcome Measure Information:

Title

Incidence of symptomatic thromboembolic events

Description

Compare the incidence of symptomatic DVT and pulmonary embolism (PE) between the two study treatment arms

Time Frame

30 days postoperative

Title

Number of adverse events

Description

To compare the safety of both the study of products

Time Frame

30 days postoperative

Title

Incidence of both Enoxaparin formulations immunogenicity

Description

To compare the levels of platelet factor 4 (PF4)-Heparin complex antibodies an platelet count between the two study treatment arms

Time Frame

0 -10 days postoperative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female over 18 years Gastrointestinal (GI) Cancer Elective or emergency surgery Preventive administration of enoxaparin sodium Exclusion Criteria: Patients participating in another study Unfractionated heparin (UFH) use up to 30 days prior to surgical procedure Renal failure with creatinine clearance <30 ml / min Known history of peripheral venous thrombosis and/or deep venous thrombosis in the 3 months prior to inclusion Pregnant or breastfeeding women or women of childbearing age not using medically accepted contraceptive method Anticoagulant use in the 3 months prior to inclusion Patients with known haemostatic disorder Patients not consenting to participate in the study, or not capable of understanding its objectives

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chadli DZIRI, MD

Organizational Affiliation

Charles Nicolle Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Charles Nicolle Hospital

City

Tunis

State/Province

Tunis BAB Souika

ZIP/Postal Code

1006

Country

Tunisia

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Comparison of Thromboembolic Events in Patients Undergoing Thromboprophylactic Treatment With ENOXA® vs Lovenox®

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