Condition category
Circulatory System
Date applied
16/08/2019
Date assigned
27/08/2019
Last edited
27/08/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Deep vein thrombosis (DVT) is a blood clot that develops within a deep vein in the body, usually in the leg.It can cause pain and swelling in the leg and may lead to complications such as pulmonary embolism. This is a serious condition that occurs when a piece of blood clot breaks off into the bloodstream and blocks one of the blood vessels in the lungs.
DVT is a common complication during postoperative convalescence. Both the complexity and frequency of plastic and reconstructive surgery (PRSx) procedures have significantly increased in Mexico over the last 25 years. It has become necessary to find more effective measures to prevent DVT. The aim of this study was to evaluate the efficacy and safety of bemiparin compared to enoxaparin for the prevention of DVT

Who can participate?
Major plastic or reconstructive surgery patients at a high risk of developing thrombosis.

What does the study involve?
Following surgery patients will be randomly allocated to receive one of two, different anti-thrombotic drugs.

What are the possible benefits and risks of participating?
Benefits: DVT risk reduction. No ultrasound study is charged to any participant.
Risks: hematoma (localized bleeding outside of blood vessels), hyperkalemia (raised potassium in blood).

Where is the study run from?
American British Cowdray Santa Fe Medical Center, Mexico

When is the study starting and how long is it expected to run for?
April 2016 to April 2018

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Dr Revilla-Peñaloza
frevp3@gmail.com


Trial website

Contact information

Type

Scientific

Primary contact

Dr Francisco Revilla-Peñaloza

ORCID ID

http://orcid.org/0000-0003-1035-8957

Contact details

Anesthesiology Service
American British Cowdray Santa Fe Medical Center
No. 154 Carlos Graef Fernandez Av.
Santa Fe
Del. Cuajimalpa
Mexico City
053333
Mexico
+52 55 1103-1600 ext. 1701
ptrapaga@abchospital.com

Type

Scientific

Additional contact

Dr Juan A. Molina Guarneros

ORCID ID

http://orcid.org/0000-0002-1946-0408

Contact details

Faculty of Medicine
Department of Pharmacology
National Autonomous University of Mexico
Av. Universidad 3000
Colonia Ciudad Universitaria
Alcaldía Coyoacán
Mexico City
04510
Mexico
+525556232164
jamg@unam.mx

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

ABC-15-17

Study information

Scientific title

Randomised trial of deep vein thrombosis chemoprophylaxis with bemiparin and enoxaparin in patients with moderate to high thrombogenic risk undergoing plastic and reconstructive surgery procedures

Acronym

RATDEVETROBEMENOXA

Study hypothesis

Compared to enoxaparin, perioperative administration of bemiparin reduces deep vein thrombosis risk without significantly increasing bleeding hazards in plastic and reconstructive surgery patients with moderate to high thrombogenic risk

Ethics approval

Approved 08/10/2015, Institutional Research and Research Ethics Committees The American British Cowdray Medical Center (Sur 136, No.116 Colonia las Américas., Mexico City, 01120, Mexico; (52)5552308097; relacionespublicas_obs@abchospital.com), ref: ABC 15-17

Study design

Single centre single blind randomized parallel trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

No participant information sheet available

Condition

Deep vein thrombosis (DVT) lower limbs

Intervention

Six hours after the end of the surgical procedure patients were assigned according to a sequential list (each new patient was alternatively assigned to either treatment group by Dr. Juan Molina (outside reader) regardless of their anthropometric characteristics or clinical condition) for single-blind subcutaneous administration of either enoxaparin 40 IU (Group-E) or bemiparin 3500 IU (Group-B) every 24 hours (q24h). Low Molecular Weight Heparin (LMWH) treatment was delivered during at least 10 days.

All patients were evaluated for DVT through Doppler ultrasound mapping of the lower limbs.

Intervention type

Drug

Phase

Phase II

Drug names

Bemiparin (Heporax) and enoxaparin (Clexane).

Primary outcome measure

Lower limb thrombogenesis: using USG Sonosite Doppler Micromax and multifrequency linear transducer from 4 to 12 MHz, to study the pelvic limbs in transversal and longitudinal sections, which yielded images in both gray scale and color, and applying Valsalva maneuvers and compression in all superficial and deep veins to looking for Thrombosis or reflux at key points. Ultrasound studies were carried out 24 hours before and 3-5 days after surgery.

Secondary outcome measures

Postoperative bleeding, measured using daily surgical drains. Timepoint: 4 days in mastoplasty cases; 15 days in abdominoplasty cases

Overall trial start date

18/03/2015

Overall trial end date

30/04/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Informed consent
2. Major plastic or reconstructive surgery patients
3. Moderate to high thrombogenic risk according to Caprini’s scale
4. Classified I-III according to American Society of Anesthesiology criteria

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80 patients

Participant exclusion criteria

1. Active bleeding
2. Heparin-induced thrombocytopenia
3. Platelet count under 100,000
4. Severe renal insufficiency
5. Coagulopathy
6. Recent intracranial surgery
7. Epidural anesthesia or lumbar puncture over the last 24 hours

Recruitment start date

01/05/2016

Recruitment end date

30/04/2018

Locations

Countries of recruitment

Mexico

Trial participating centre

American British Cowdray Santa Fe Medical Center
No. 154 Carlos Graef Fernandez Av. Santa Fe Del. Cuajimalpa
Mexico City
053333
Mexico

Sponsor information

Organisation

Institutional Research and Research Ethics Committees The American British Cowdray Medical Center, Mexico City.

Sponsor details

Sur 136
No.116 Colonia las Américas.
Mexico City
01120
Mexico
(52)5552308097, (52)5552308000. Ext.8497
relacionespublicas_obs@abchospital.com

Sponsor type

Hospital/treatment centre

Website

http://www.abchospital.com

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Submission to either Clinical and Applied Thrombosis/Hemostasis Journal or Thrombosis and Hemostasis.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available as participants did not agree to make the data public.

Intention to publish date

30/08/2019

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

27/08/2019: Trial’s existence confirmed by The American British Cowdray Medical Center