The use of bemiparin to prevent deep vein thrombosis in plastic and reconstructive surgery patients

ISRCTN	ISRCTN13851176
DOI	https://doi.org/10.1186/ISRCTN13851176
Secondary identifying numbers	ABC-15-17

Submission date: 16/08/2019
Registration date: 27/08/2019
Last edited: 18/02/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Francisco Revilla-Peñaloza
Scientific

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

ORCID ID	0000-0003-1035-8957
Phone	+52 55 1103-1600 ext. 1701
Email	ptrapaga@abchospital.com

Dr Juan A. Molina Guarneros
Scientific

Faculty of Medicine
Department of Pharmacology
National Autonomous University of Mexico
Av. Universidad 3000, Colonia Ciudad Universitaria, Alcaldía Coyoacán
Mexico City
04510
Mexico

ORCID ID	0000-0002-1946-0408
Phone	+525556232164
Email	jamg@unam.mx

Study information

Study design	Single centre single blind randomized parallel trial
Primary study design	Interventional
Secondary study design	Randomised parallel trial
Study setting(s)	Hospital
Study type	Prevention
Participant information sheet	No participant information sheet available
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
Study acronym	RATDEVETROBEMENOXA
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase II
Drug / device / biological / vaccine name(s)	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 study start date	18/03/2015
Completion date	30/04/2018

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	80 patients
Total final enrolment	78
Key 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
Key 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
Date of first enrolment	01/05/2016
Date of final enrolment	30/04/2018

Locations

Countries of recruitment

Mexico

Study 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

Institutional Research and Research Ethics Committees The American British Cowdray Medical Center, Mexico City.
Hospital/treatment centre

Sur 136
No.116 Colonia las Américas.
Mexico City
01120
Mexico

Phone	(52)5552308097, (52)5552308000. Ext.8497
Email	relacionespublicas_obs@abchospital.com
Website	http://www.abchospital.com
"ROR"	https://ror.org/03e36d037

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date	30/08/2019
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Submission to either Clinical and Applied Thrombosis/Hemostasis Journal or Thrombosis and Hemostasis.
IPD sharing plan	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.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2020		Yes	No

Editorial Notes

18/02/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
27/08/2019: Trial’s existence confirmed by The American British Cowdray Medical Center