Postoperative Bleeding Prevention in Massive Bone Tumour Resection

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

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02153593

Acronym

TRANEXTUM

Enrollment

Registered

2014-06-03

Start date

2013-03-31

Completion date

2015-05-31

Last updated

2016-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Blood Loss, Bone Tumour

Keywords

Clinical trial, Randomized, Fibrin glue, Tranexamic acid, Blood loss

Brief 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.

Interventions

DRUGTranexamic Acid

1g intra-articular before closing the wound surgery

DRUGFibrin glue

5mL intra-articular before closing the wound surgery

PROCEDUREElectrocauterization

Coagulation blood from vessels by means of a electrocautery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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
Proportion of patients requiring blood transfusion	The first postoperative 2 weeks
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
Postoperative pain related with the surgery	The first postoperative week

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026