NCT02808273

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 78 (actual)
• Sponsor: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Patients Undergoing Microvascular Surgery

Interventions

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

Timeline

• Start date: 2016-02-02
• Primary completion: 2018-10-12
• Completion: 2018-10-12
• First posted: 2016-06-21
• Last updated: 2019-02-11

Locations

1 site across 1 country: Spain