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

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

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.

Study Overview

• Status: Completed
• Conditions: Patients Undergoing Microvascular Surgery
• Intervention / Treatment: Drug: Bemiparine

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 Type: Observational
• Enrollment (Actual): 78

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28034
    • Ramón y Cajal Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who will undergo Oral and Maxillofacial or Plastic surgery that require reconstruction with microvascular flap at Hospital Ramón y Cajal, Madrid. A group of 67 patients treated according to a protocol for prevention of postoperative deep venous thrombosis with Bemiparina that will be compared with data collected from a group of 134 patients previously treated with a similar protocol but enoxaparin as antithrombotic agent.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Retrospective control; Patients who had received enoxaparine as antithrombotic according to a protocol for prevention of postoperative deep venous thrombosis
Prospective Cohort; Patients who will receive bemiparine 3500 UI as antithrombotic according to a protocol for prevention of postoperative deep venous thrombosis	Drug: Bemiparine; Bemiparine 3500 UI as antithrombotic according to a protocol for prevention of postoperative deep venous thrombosis; Other Names: Hibor (3500UI/0,2ml)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To compare the use of Bemiparine, against Clexane as an antithrombotic agent	Incidence thrombotic complications and bleeding	24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Incidence of deep vein thrombosis and pulmonary embolism	24 months
Incidence of postsurgery hemorrhagic strokes with both drugs	24 months

Collaborators and Investigators

• Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Collaborators: Rovi Pharmaceuticals Laboratories
• Investigators: Principal Investigator: Julio Acero Sanz, MD; PhD, Ramón y Cajal Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2016
• Primary Completion (Actual): October 12, 2018
• Study Completion (Actual): October 12, 2018

Study Registration Dates

• First Submitted: March 4, 2016
• First Submitted That Met QC Criteria: June 20, 2016
• First Posted (Estimate): June 21, 2016

Study Record Updates

• Last Update Posted (Actual): February 11, 2019
• Last Update Submitted That Met QC Criteria: February 8, 2019
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Comparative study; Bemiparine; Antithrombotic microsurgery protocol; Anticoagulant microsurgery protocol
• Other Study ID Numbers: FUN-BEM-2015-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No