Postoperative Bleeding Prevention in Massive Bone Tumour Resection

Phase 3

Terminated

• Conditions: Blood Loss; Bone Tumour
• Interventions: Drug: Tranexamic Acid; Drug: Fibrin glue; Procedure: Electrocauterization

• Registration Number: NCT02153593
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2014-05-27
• Study First Submitted QC: 2014-06-02
• Study First Posted: 2014-06-03
• Primary Completion: 2015-03
• Study Completion: 2015-05
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-19
• Last Update Posted: 2016-09-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 56

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tranexamic acid	Tranexamic Acid	Tranexamic acid, 1g intra-articular before closing the surgery wound
Tranexamic acid	Electrocauterization	Tranexamic acid, 1g intra-articular before closing the surgery wound
Fibrin glue	Fibrin glue	One intra-articular dose of fibrin glue (Evicel 5mL) before closing the wound surgery
Fibrin glue	Electrocauterization	One intra-articular dose of fibrin glue (Evicel 5mL) before closing the wound surgery
Usual hemostasia	Electrocauterization	Electrocauterization

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Proportion of patients with wound infection	The first postoperative month
Proportion of patients requiring blood transfusion	The first postoperative 2 weeks
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
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
Units of blood transfused	The first postoperative 2 weeks
Tumoral systemic dissemination rate	The first postoperative month
Mortality	The first postoperative month
Length of hospital stay	The first postoperative 2 weeks

Trial Locations

Locations (3)

Hospital Universitario de San Juan de Alicante; 🇪🇸 Alicante, Spain

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Universitario de Cruces; 🇪🇸 Barakaldo,, Vizcaya, Spain