NCT02128178

Brief Summary

Obese patients undergoing bariatric surgery warrant VTE prophylaxis because they are at high risk for developing a fatal pulmonary embolism or postthrombotic syndrome. However, a consensus does not exist on the most effective prophylactic approach.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
700

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2013

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

November 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

April 8, 2015

Status Verified

April 1, 2015

Enrollment Period

2.4 years

First QC Date

April 22, 2014

Last Update Submit

April 7, 2015

Conditions

Morbid ObesityPulmonary Embolism

Keywords

Morbid obesityLaparoscopic surgeryCompression ultrasonographyPulmonary embolismBleeding

Outcome Measures

Primary Outcomes (1)

  • Venous thrombosis and/or pulmonary embolism (PE)

    To assess the venous thrombosis by compression ultrasonography and PE in suspected patients

    Postoperative 4 weeks

Secondary Outcomes (2)

  • Bleeding from the surgery site , drain if any, GIT bleeding,

    postoperative 4 weeks

  • hospital stay

    4 WEEKS

Study Arms (2)

ENOXAPARIN 2 HOURS BEFORE

ACTIVE COMPARATOR

Giving 40 mg enoxaparin SQ 2 hours before surgery and daily for 10 days thereafter

Drug: Enoxaparin 40 mg 2 hours before armDrug: Enoxaparin 40 mg 12 hours before arm

Enoxaparin 40 mg 12 hours before

ACTIVE COMPARATOR

Enoxaparin 40 mg 12 hours before surgery and once daily for 10 days thereafter

Drug: Enoxaparin 40 mg 2 hours before armDrug: Enoxaparin 40 mg 12 hours before arm

Interventions

Enoxaparin 40 mg 2 hours before armDRUG

Enoxaparin 40 mg 2 hours before surgery

Also known as: First group
ENOXAPARIN 2 HOURS BEFOREEnoxaparin 40 mg 12 hours before
Enoxaparin 40 mg 12 hours before armDRUG

Enoxaparin 40 mg 12 hours before surgery

Also known as: second group
ENOXAPARIN 2 HOURS BEFOREEnoxaparin 40 mg 12 hours before

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \>40 OR \>35 with comorbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Manoura University

Al Mansurah, Egypt

RECRUITING

Related Publications (1)

  • Amaral FC, Baptista-Silva JC, Nakano LC, Flumignan RL. Pharmacological interventions for preventing venous thromboembolism in people undergoing bariatric surgery. Cochrane Database Syst Rev. 2022 Nov 22;11(11):CD013683. doi: 10.1002/14651858.CD013683.pub2.

    PMID: 36413425DERIVED

MeSH Terms

Conditions

Obesity, MorbidPulmonary EmbolismHemorrhage

Interventions

Enoxaparin

Condition Hierarchy (Ancestors)

ObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsLung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPathologic Processes

Intervention Hierarchy (Ancestors)

Heparin, Low-Molecular-WeightHeparinGlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • mohamed e abd ellatif, phd

    Mansoura University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

mohamed e abd ellatif, phd

CONTACT

surg_latif@hotmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
phd

Study Record Dates

First Submitted

April 22, 2014

First Posted

May 1, 2014

Study Start

November 1, 2013

Primary Completion

April 1, 2016

Study Completion

May 1, 2016

Last Updated

April 8, 2015

Record last verified: 2015-04

Locations

EG(1)