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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

78 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-02

Study Completion Date

2018-10-12

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Patients Undergoing Microvascular Surgery

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Retrospective control

Patients who had received enoxaparine as antithrombotic according to a protocol for prevention of postoperative deep venous thrombosis

No interventions assigned to this group

Prospective Cohort

Patients who will receive bemiparine 3500 UI as antithrombotic according to a protocol for prevention of postoperative deep venous thrombosis

Bemiparine

Intervention Type DRUG

Bemiparine 3500 UI as antithrombotic according to a protocol for prevention of postoperative deep venous thrombosis

Interventions

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Bemiparine

Bemiparine 3500 UI as antithrombotic according to a protocol for prevention of postoperative deep venous thrombosis

Intervention Type DRUG

Other Intervention Names

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Hibor (3500UI/0,2ml)

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No