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

Completed

• Conditions: Patients Undergoing Microvascular Surgery
• Interventions: Drug: Bemiparine

• Registration Number: NCT02808273
• Lead Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2016-02-02
• Study First Submitted: 2016-03-04
• Study First Submitted QC: 2016-06-20
• Study First Posted: 2016-06-21
• Status Verified: 2018-02
• Primary Completion: 2018-10-12
• Study Completion: 2018-10-12
• Last Update Submitted: 2019-02-08
• Last Update Posted: 2019-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Prospective Cohort	Bemiparine	Patients who will receive bemiparine 3500 UI as antithrombotic according to a protocol for prevention of postoperative deep venous thrombosis

Primary Outcome Measures

Name	Time	Method
To compare the use of Bemiparine, against Clexane as an antithrombotic agent	24 months	Incidence thrombotic complications and bleeding

Secondary Outcome Measures

Name	Time	Method
Incidence of deep vein thrombosis and pulmonary embolism	24 months
Incidence of postsurgery hemorrhagic strokes with both drugs	24 months

Trial Locations

Locations (1)

Ramon y Cajal Hospital; 🇪🇸 Madrid, Spain