Postoperative Bleeding Prevention in Massive Bone Tumour Resection (TRANEXTUM)

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

Status and phase: Terminated; Phase 3

Conditions: Bone Tumour; Blood Loss

Treatments: Drug: Tranexamic Acid; Drug: Fibrin glue; Procedure: Electrocauterization

Study type: Interventional

Funder types: Other

Identifiers

NCT02153593

IIBSP-EVI-2011-138

2011-006276-40 (EudraCT Number)

EC11-340 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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56 participants in 3 patient groups

Tranexamic acid

Experimental group

Description:

Tranexamic acid, 1g intra-articular before closing the surgery wound

Treatment:

Drug: Tranexamic Acid

Procedure: Electrocauterization

Fibrin glue

Experimental group

Description:

One intra-articular dose of fibrin glue (Evicel 5mL) before closing the wound surgery

Treatment:

Drug: Fibrin glue

Procedure: Electrocauterization

Usual hemostasia

Active Comparator group

Description:

Electrocauterization

Treatment:

Procedure: Electrocauterization