Clinical trial NCT02808273: Use of Bemiparine as a Prophylactic Antithrombotic Agent, in Patients Undergoing Microsurgery for Head and Neck Reconstruction
Official title: Use of Bemiparine as a Prophylactic Antitrombotic Agent, in Patients Undergoing Microsurgery for Head and Neck Reconstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patients Undergoing Microvascular Surgery
Keywords: Bemiparine
Antithrombotic microsurgery protocol
Comparative study
Anticoagulant microsurgery protocol
Lead sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Sponsor class: OTHER
Collaborators: name: Rovi Pharmaceuticals Laboratories
First posted: 2016-06-21
Enrollment: 78
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: To compare the use of Bemiparine, against Clexane as an antithrombotic agent
timeFrame: 24 months
Secondary outcomes:
measure: Incidence of deep vein thrombosis and pulmonary embolism
timeFrame: 24 months
measure: Incidence of postsurgery hemorrhagic strokes with both drugs
timeFrame: 24 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Ramon y Cajal Hospital
Study officials:
affiliation: Ramon y Cajal Hospital
name: Julio Acero Sanz, MD; PhD
role: PRINCIPAL_INVESTIGATOR
References: