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

NCT02808273 | Completed

• 1 other identifier: FUN-BEM-2015-01
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Patients Undergoing Microvascular Surgery

Keywords

Bemiparine; Antithrombotic microsurgery protocol; Comparative study; Anticoagulant microsurgery protocol

Outcome Measures

Primary Outcomes (1)

• To compare the use of Bemiparine, against Clexane as an antithrombotic agent

  Incidence thrombotic complications and bleeding

  24 months

Secondary Outcomes (2)

• Incidence of deep vein thrombosis and pulmonary embolism

  24 months

• Incidence of postsurgery hemorrhagic strokes with both drugs

  24 months

Study Arms (2)

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

Interventions

Bemiparine DRUG

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

Also known as: Hibor (3500UI/0,2ml)

Prospective Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal: lead
• Rovi Pharmaceuticals Laboratories: collaborator

Study Sites (1)

Ramon y Cajal Hospital

Madrid, 28034, Spain

Location

Study Officials

• Julio Acero Sanz, MD; PhD

  Ramon y Cajal Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2016
• First Posted: June 21, 2016
• Study Start: February 2, 2016
• Primary Completion: October 12, 2018
• Study Completion: October 12, 2018
• Last Updated: February 11, 2019

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)