Postoperative Bleeding Prevention in Massive Bone Tumour Resection (TRANEXTUM)

Postoperative Bleeding Prevention in Massive Bone Tumour Resection: a Multicentric, Randomized, Parallel, Controlled Trial to Assess the Efficacy of Tranexamic Acid Versus Evicel® and Usual Haemostasis

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 Overview

• Status: Terminated
• Conditions: Blood Loss; Bone Tumour
• Intervention / Treatment: Drug: Tranexamic Acid; Procedure: Electrocauterization; Drug: Fibrin glue

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Alicante, Spain, 03550
    • Hospital Universitario de San Juan de Alicante
  • Barcelona, Spain, 08025
    • Hospital De La Santa Creu I Sant Pau
  • Vizcaya
    • Barakaldo,, Vizcaya, Spain, 48903
      • Hospital Universitario de Cruces

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tranexamic acid; Tranexamic acid, 1g intra-articular before closing the surgery wound	Drug: Tranexamic Acid; 1g intra-articular before closing the wound surgery; Other Names: Amchafibrin; Procedure: Electrocauterization; Coagulation blood from vessels by means of a electrocautery
Experimental: Fibrin glue; One intra-articular dose of fibrin glue (Evicel 5mL) before closing the wound surgery	Procedure: Electrocauterization; Coagulation blood from vessels by means of a electrocautery; Drug: Fibrin glue; 5mL intra-articular before closing the wound surgery; Other Names: Evicel
Active Comparator: Usual hemostasia; Electrocauterization	Procedure: Electrocauterization; Coagulation blood from vessels by means of a electrocautery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total blood loss (mL) in the postoperative period	The blood loss will be collected by the drainage system and quantified in mL.	The first postoperative 48h

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients requiring blood transfusion	The first postoperative 2 weeks
Units of blood transfused	The first postoperative 2 weeks
Proportion of patients with wound infection	The first postoperative month
Proportion of patients with wound dehiscence	The first postoperative month
Proportion of patients with reoperation for wound complications	The first postoperative month
Deep venous thrombosis	The first postoperative 2 weeks
Proportion of patients with seroma	The first postoperative month
Postoperative pain related with the surgery	The first postoperative week
Tumoral local relapse rate	The first postoperative month
Tumoral systemic dissemination rate	The first postoperative month
Mortality	The first postoperative month
Proportion of patients in which chemotherapy is delayed for wound complications	The first postoperative month
Proportion of patients in which radiotherapy is delayed for wound complications.	The first postoperative month
Length of hospital stay	The first postoperative 2 weeks

Collaborators and Investigators

• Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Investigators: Principal Investigator: Ana Peiró, MD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Publications and helpful links

General Publications

• Ibáñez AP, Martinez-Zapata MJ, Tarragó LT, Balaguer MB, Roig XA, Joy IG, Areizaga L, Merino J, Alcalá R, Tranextum Study Group. Postoperative bleeding prevention in massive bone tumour resection: a multicentric, randomized, parallel, controlled trial to assess the efficacy of tranexamic acid versus Evicel and usual haemostasis [protocol]. Basic and Clinical Pharmacology. 2014; 115 (Suppl 3): 20-21.

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: May 27, 2014
• First Submitted That Met QC Criteria: June 2, 2014
• First Posted (Estimate): June 3, 2014

Study Record Updates

• Last Update Posted (Estimate): September 20, 2016
• Last Update Submitted That Met QC Criteria: September 19, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Randomized; Clinical trial; Tranexamic acid; Blood loss; Fibrin glue
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Site; Postoperative Complications; Musculoskeletal Diseases; Bone Diseases; Hemorrhage; Bone Neoplasms; Postoperative Hemorrhage; Molecular Mechanisms of Pharmacological Action; Fibrin Modulating Agents; Antifibrinolytic Agents; Hemostatics; Coagulants; Fibrin Tissue Adhesive; Tranexamic Acid
• Other Study ID Numbers: IIBSP-EVI-2011-138; EC11-340 (Other Grant/Funding Number: Ministry of Health and Social Policy 2011); 2011-006276-40 (EudraCT Number)