Use of Bemiparine as a Prophylactic Antithrombotic Agent, in Patients Undergoing Microsurgery for Head and Neck Reconstruction

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Status

Completed

Conditions

Patients Undergoing Microvascular Surgery

Treatments

Drug: Bemiparine

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT02808273

FUN-BEM-2015-01

Details and patient eligibility

About

A comparative study to reveal if the use of Bemiparine (Hibor) versus Enoxaparin (Clexane) as an antithrombotic agent, shows an advantage on the rate of thrombotic and haemorrhagic events in microsurgicals free flaps during head and neck reconstruction.

Full description

This is an observational post-authorization study on a group of patients undergoing microsurgery on the Oral and Maxillofacial Surgery and Plastic and Reconstructive Surgery Service at Ramon y Cajal Hospital, Madrid for processes that require reconstruction with a flap microvascular. A group of 67 patients treated according protocol postoperative prevention of deep vein thrombosis with Bemiparina will be compared with data collected retrospectively from a group of 134 patients treated previously with an earlier protocol with enoxaparin as main antithrombotic agent.

Enrollment

78 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients that will undergo reconstructive surgery for defects in any part of the body, especially in head and neck, after cancer, traumatic or infectious pathology, which will require the use of techniques of microsurgery.
Patients who have given their informed consent
Patients in which it has been decided to use thromboprophylaxis with bemiparina before proposing them to participate in the study.

Exclusion criteria

Patients not eligible for repair through the use of free flaps, and therefore the use of Microsurgical techniques for vascular anastomosis
Patients with an underlying pathology that may interfere to a clinically significant or contraindicated the use of Bemiparina, such as: serious hepatic or renal insufficiency, uncontrolled arterial hypertension, history of gastroduodenal, thrombocytopenia, nephrolithiasis or uretrolitiasis and vascular disease ulcer of choroid and retina.
Refusal of the patient or their family members to participate in the study.
Pregnancy and breastfeeding
Known hypersensitivity to study drugs or any of its components