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

Patients Undergoing Microvascular Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02808273
• Other study ID #: FUN-BEM-2015-01
• Status: Completed
• Start date: February 2, 2016
• Est. completion date: October 12, 2018

Study information

• Verified date: February 2018
• Source: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: October 12, 2018
• Est. primary completion date: October 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Patients Undergoing Microvascular Surgery

Intervention

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

Locations

Country	Name	City	State
Spain	Ramon y Cajal Hospital	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal	Rovi Pharmaceuticals Laboratories

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare the use of Bemiparine, against Clexane as an antithrombotic agent	Incidence thrombotic complications and bleeding	24 months
Secondary	Incidence of deep vein thrombosis and pulmonary embolism		24 months
Secondary	Incidence of postsurgery hemorrhagic strokes with both drugs		24 months