Postoperative Bleeding Prevention in Massive Bone Tumour Resection

Blood Loss Clinical Trial

— TRANEXTUM  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02153593
• Other study ID #: IIBSP-EVI-2011-138
• Secondary ID: EC11-3402011-006
• Status: Terminated
• Phase: Phase 3
• First received: May 27, 2014
• Last updated: September 19, 2016
• Start date: March 2013
• Est. completion date: May 2015

Study information

• Verified date: September 2016
• Source: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 56
• Est. completion date: May 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blood Loss
• Bone Neoplasms
• Bone Tumour
• Hemorrhage
• Postoperative Hemorrhage

Intervention

Drug:
• Tranexamic Acid
1g intra-articular before closing the wound surgery
• Fibrin glue
5mL intra-articular before closing the wound surgery

Procedure:
• Electrocauterization
Coagulation blood from vessels by means of a electrocautery

Locations

Country	Name	City	State
Spain	Hospital Universitario de San Juan de Alicante	Alicante
Spain	Hospital Universitario de Cruces	Barakaldo,	Vizcaya
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Proportion of patients requiring blood transfusion		The first postoperative 2 weeks	Yes
Secondary	Units of blood transfused		The first postoperative 2 weeks	Yes
Secondary	Proportion of patients with wound infection		The first postoperative month	Yes
Secondary	Proportion of patients with wound dehiscence		The first postoperative month	Yes
Secondary	Proportion of patients with reoperation for wound complications		The first postoperative month	Yes
Secondary	Deep venous thrombosis		The first postoperative 2 weeks	No
Secondary	Proportion of patients with seroma		The first postoperative month	Yes
Secondary	Postoperative pain related with the surgery		The first postoperative week	Yes
Secondary	Tumoral local relapse rate		The first postoperative month	Yes
Secondary	Tumoral systemic dissemination rate		The first postoperative month	Yes
Secondary	Mortality		The first postoperative month	No
Secondary	Proportion of patients in which chemotherapy is delayed for wound complications		The first postoperative month	Yes
Secondary	Proportion of patients in which radiotherapy is delayed for wound complications.		The first postoperative month	Yes
Secondary	Length of hospital stay		The first postoperative 2 weeks	No