Postoperative Bleeding Prevention in Massive Bone Tumour Resection

Phase 3TerminatedNCT02153593

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau56 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Blood Loss Bone Tumour

Interventions

Tranexamic AcidDRUG

1g intra-articular before closing the wound surgery

Fibrin glueDRUG

5mL intra-articular before closing the wound surgery

ElectrocauterizationPROCEDURE

Coagulation blood from vessels by means of a electrocautery

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Hospital Universitario de San Juan de Alicante

Alicante, Alicante, Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, Spain

Hospital Universitario de Cruces

Barakaldo, Vizcaya, Spain

Outcomes

Primary Outcomes

Total blood loss (mL) in the postoperative period

The blood loss will be collected by the drainage system and quantified in mL.

Time frame: The first postoperative 48h

Secondary Outcomes

Proportion of patients requiring blood transfusion

Time frame: The first postoperative 2 weeks

Units of blood transfused

Time frame: The first postoperative 2 weeks

Proportion of patients with wound infection