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

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

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13851176
Enrollment
80
Registered
2019-08-27
Start date
2016-05-01
Completion date
Unknown
Last updated
2020-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep vein thrombosis (DVT) lower limbs Circulatory System Deep vein thrombosis

Interventions

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 (outsi

Sponsors

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

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

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

Countries

Mexico

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026