NCT02444572

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2015

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 14, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2015

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2020

Completed
Last Updated

July 29, 2021

Status Verified

July 1, 2021

Enrollment Period

4.8 years

First QC Date

May 7, 2015

Last Update Submit

July 27, 2021

Conditions

Gastrointestinal NeoplasmsThromboembolic Event

Keywords

EnoxaparinImmunogenicity

Outcome Measures

Primary Outcomes (1)

  • 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

    7 - 10 days postoperative

Secondary Outcomes (3)

  • Incidence of symptomatic thromboembolic events

    30 days postoperative

  • Number of adverse events

    30 days postoperative

  • Incidence of both Enoxaparin formulations immunogenicity

    0 -10 days postoperative

Study Arms (2)

ENOXA® group

EXPERIMENTAL

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

Drug: Enoxaparin 4000 IU

LOVENOX® group

ACTIVE COMPARATOR

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

Drug: Enoxaparin 4000 IU

Interventions

Enoxaparin 4000 IUDRUG
Also known as: ENOXA®, LOVENOX®
ENOXA® groupLOVENOX® group

Eligibility Criteria

Age19 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • Pregnant or breastfeeding women or women of childbearing age not using medically accepted contraceptive method
  • Patients with known haemostatic disorder
  • Patients not consenting to participate in the study, or not capable of understanding its objectives

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charles Nicolle Hospital

Tunis, Tunis BAB Souika, 1006, Tunisia

Location

Related Publications (1)

  • Dziri C, Ben Hmida W, Dougaz W, Khalfallah M, Samaali I, Jerraya H, Bouasker I, Nouira R. Biosimilar versus branded enoxaparin to prevent postoperative venous thromboembolism after surgery for digestive tract cancer: Randomized trial. PLoS One. 2023 Nov 1;18(11):e0293269. doi: 10.1371/journal.pone.0293269. eCollection 2023.

    PMID: 37910523DERIVED

MeSH Terms

Conditions

Gastrointestinal NeoplasmsThromboembolism

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Chadli DZIRI, MD

    Charles Nicolle Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2015

First Posted

May 14, 2015

Study Start

October 1, 2015

Primary Completion

July 1, 2020

Study Completion

July 10, 2020

Last Updated

July 29, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)