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Postoperative Bleeding Prevention in Massive Bone Tumour Resection (TRANEXTUM)

Primary Purpose

Blood Loss, Bone Tumour

Status
Terminated
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Tranexamic Acid
Fibrin glue
Electrocauterization
Sponsored by
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Blood Loss focused on measuring Clinical trial, Randomized, Fibrin glue, Tranexamic acid, Blood loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital Universitario de Cruces
  • Hospital Universitario de San Juan de Alicante
  • Hospital de la Santa Creu i Sant Pau

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Tranexamic acid

Fibrin glue

Usual hemostasia

Arm Description

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

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

Electrocauterization

Outcomes

Primary Outcome Measures

Total blood loss (mL) in the postoperative period
The blood loss will be collected by the drainage system and quantified in mL.

Secondary Outcome Measures

Proportion of patients requiring blood transfusion
Units of blood transfused
Proportion of patients with wound infection
Proportion of patients with wound dehiscence
Proportion of patients with reoperation for wound complications
Deep venous thrombosis
Proportion of patients with seroma
Postoperative pain related with the surgery
Tumoral local relapse rate
Tumoral systemic dissemination rate
Mortality
Proportion of patients in which chemotherapy is delayed for wound complications
Proportion of patients in which radiotherapy is delayed for wound complications.
Length of hospital stay

Full Information

First Posted
May 27, 2014
Last Updated
September 19, 2016
Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
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1. Study Identification

Unique Protocol Identification Number
NCT02153593
Brief Title
Postoperative Bleeding Prevention in Massive Bone Tumour Resection
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Why Stopped
Difficulty in recruitment
Study Start Date
March 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blood Loss, Bone Tumour
Keywords
Clinical trial, Randomized, Fibrin glue, Tranexamic acid, Blood loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tranexamic acid
Arm Type
Experimental
Arm Description
Tranexamic acid, 1g intra-articular before closing the surgery wound
Arm Title
Fibrin glue
Arm Type
Experimental
Arm Description
One intra-articular dose of fibrin glue (Evicel 5mL) before closing the wound surgery
Arm Title
Usual hemostasia
Arm Type
Active Comparator
Arm Description
Electrocauterization
Intervention Type
Drug
Intervention Name(s)
Tranexamic Acid
Other Intervention Name(s)
Amchafibrin
Intervention Description
1g intra-articular before closing the wound surgery
Intervention Type
Drug
Intervention Name(s)
Fibrin glue
Other Intervention Name(s)
Evicel
Intervention Description
5mL intra-articular before closing the wound surgery
Intervention Type
Procedure
Intervention Name(s)
Electrocauterization
Intervention Description
Coagulation blood from vessels by means of a electrocautery
Primary Outcome Measure Information:
Title
Total blood loss (mL) in the postoperative period
Description
The blood loss will be collected by the drainage system and quantified in mL.
Time Frame
The first postoperative 48h
Secondary Outcome Measure Information:
Title
Proportion of patients requiring blood transfusion
Time Frame
The first postoperative 2 weeks
Title
Units of blood transfused
Time Frame
The first postoperative 2 weeks
Title
Proportion of patients with wound infection
Time Frame
The first postoperative month
Title
Proportion of patients with wound dehiscence
Time Frame
The first postoperative month
Title
Proportion of patients with reoperation for wound complications
Time Frame
The first postoperative month
Title
Deep venous thrombosis
Time Frame
The first postoperative 2 weeks
Title
Proportion of patients with seroma
Time Frame
The first postoperative month
Title
Postoperative pain related with the surgery
Time Frame
The first postoperative week
Title
Tumoral local relapse rate
Time Frame
The first postoperative month
Title
Tumoral systemic dissemination rate
Time Frame
The first postoperative month
Title
Mortality
Time Frame
The first postoperative month
Title
Proportion of patients in which chemotherapy is delayed for wound complications
Time Frame
The first postoperative month
Title
Proportion of patients in which radiotherapy is delayed for wound complications.
Time Frame
The first postoperative month
Title
Length of hospital stay
Time Frame
The first postoperative 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana Peiró, MD
Organizational Affiliation
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario de Cruces
City
Barakaldo,
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital Universitario de San Juan de Alicante
City
Alicante
ZIP/Postal Code
03550
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
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Postoperative Bleeding Prevention in Massive Bone Tumour Resection

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