Postoperative Bleeding Prevention in Massive Bone Tumour Resection

• Status: Terminated
• Trial end date: 2015-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Massive bone tumour resection is often associated with important postoperative bleeding. This may determine systemic (anaemia), as well as local complications (wound healing, seroma, haematoma).

The objective of this study is to determine whether the use of topical tranexamic acid or topical Evicel® will reduce the perioperative bleeding comparing it with usual haemostasis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Treatments: Fibrin Tissue Adhesive; Tranexamic Acid

Criteria

Inclusion Criteria:

• 18 years and older

• Musculoskeletal tumor (primary or metastatic, benign or malignant) located in extremities, shoulder girdle or pelvis.

• Massive or bloc tumour resection.

• Patient's consent to participate

Exclusion Criteria:

• Known allergy to ATX

• Allergy or known hypersensitivity to bovine proteins (aprotinin)

• Liposarcomas low grade

• History of thromboembolic disease or prothrombotic conditions:

• cerebral vascular accident

• ischemic heart disease

• deep and / or superficial vein thrombosis

• pulmonary embolism

• peripheral arterial vasculopathy

• thrombogenic arrhythmias (eg: ACxFA)

• patients with cardiovascular stents

• prothrombotic alterations in coagulation

• Treatment with contraceptive drugs