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
Total final enrolment
78
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
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
2019 results in https://www.ncbi.nlm.nih.gov/pubmed/31853609