NCT02153593

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2013

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 3, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

September 20, 2016

Status Verified

September 1, 2016

Enrollment Period

2 years

First QC Date

May 27, 2014

Last Update Submit

September 19, 2016

Conditions

Blood LossBone Tumour

Keywords

Clinical trialRandomizedFibrin glueTranexamic acidBlood loss

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (14)

  • 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

  • +9 more secondary outcomes

Study Arms (3)

Tranexamic acid

EXPERIMENTAL

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

Drug: Tranexamic AcidProcedure: Electrocauterization

Fibrin glue

EXPERIMENTAL

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

Drug: Fibrin glueProcedure: Electrocauterization

Usual hemostasia

ACTIVE COMPARATOR

Electrocauterization

Procedure: Electrocauterization

Interventions

Tranexamic AcidDRUG

1g intra-articular before closing the wound surgery

Also known as: Amchafibrin
Tranexamic acid
Fibrin glueDRUG

5mL intra-articular before closing the wound surgery

Also known as: Evicel
Fibrin glue
ElectrocauterizationPROCEDURE

Coagulation blood from vessels by means of a electrocautery

Fibrin glueTranexamic acidUsual hemostasia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital Universitario de San Juan de Alicante

Alicante, Alicante, 03550, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, Barcelona, 08025, Spain

Location

Hospital Universitario de Cruces

Barakaldo, Vizcaya, 48903, Spain

Location

Related 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.

    BACKGROUND

MeSH Terms

Conditions

HemorrhageBone Neoplasms

Interventions

Tranexamic AcidFibrin Tissue AdhesiveDiathermy

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanecarboxylic AcidsAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsFibrinBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsHyperthermia, InducedTherapeutics

Study Officials

  • Ana Peiró, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2014

First Posted

June 3, 2014

Study Start

March 1, 2013

Primary Completion

March 1, 2015

Study Completion

May 1, 2015

Last Updated

September 20, 2016

Record last verified: 2016-09

Locations

ES(3)