AzTrials
AzTrials

Blood LossPhase 3TRANEXTUMNCT02153593

Postoperative Bleeding Prevention in Massive Bone Tumour Resection

A Phase 3 study testing Tranexamic Acid, Fibrin glue and Electrocauterization in people with Blood Loss and Bone Tumour, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 3 sites in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Blood Loss, Bone Tumour
What is being tested?
Tranexamic Acid, Fibrin glue and Electrocauterization
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
3 sitesSpain
Study dates
Mar 2013to May 2015
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

3 sites in 1 country.

Spain3 sites

  • Hospital Universitario de San Juan de Alicante

    Alicante, Alicante, 03550

  • Hospital Universitario de Cruces

    Barakaldo, Vizcaya, 48903

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Barcelona, 08025

Other trials in Spain

About this study

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

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.

Being tested
Tranexamic Acid, Fibrin glue, Electrocauterization
Keywords
Clinical trial, Randomized, Fibrin glue, Tranexamic acid, Blood loss
Medical subject headings
Hemorrhage, Bone Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tranexamic AcidDrug

    Also called Amchafibrin

    1g intra-articular before closing the wound surgery

  • Fibrin glueDrug

    Also called Evicel

    5mL intra-articular before closing the wound surgery

  • ElectrocauterizationProcedure or surgery

    Coagulation blood from vessels by means of a electrocautery

Study groups in NCT02153593
Study groupRoleWhat they receive
Tranexamic acidExperimentalTranexamic acid, 1g intra-articular before closing the surgery wound
Receives: Drug: Tranexamic Acid; Procedure: Electrocauterization
Fibrin glueExperimentalOne intra-articular dose of fibrin glue (Evicel 5mL) before closing the wound surgery
Receives: Drug: Fibrin glue; Procedure: Electrocauterization
Usual hemostasiaActive comparatorElectrocauterization
Receives: Procedure: Electrocauterization

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total blood loss (mL) in the postoperative period

    The blood loss will be collected by the drainage system and quantified in mL.

    Measured: The first postoperative 48h

Secondary outcomes (14)

  1. Proportion of patients requiring blood transfusion

    Measured: The first postoperative 2 weeks

  2. Units of blood transfused

    Measured: The first postoperative 2 weeks

  3. Proportion of patients with wound infection

    Measured: The first postoperative month

  4. Proportion of patients with wound dehiscence

    Measured: The first postoperative month

  5. Proportion of patients with reoperation for wound complications

    Measured: The first postoperative month

  6. Deep venous thrombosis

    Measured: The first postoperative 2 weeks

  7. Proportion of patients with seroma

    Measured: The first postoperative month

  8. Postoperative pain related with the surgery

    Measured: The first postoperative week

  9. Tumoral local relapse rate

    Measured: The first postoperative month

  10. Tumoral systemic dissemination rate

    Measured: The first postoperative month

  11. Mortality

    Measured: The first postoperative month

  12. Proportion of patients in which chemotherapy is delayed for wound complications

    Measured: The first postoperative month

  13. Proportion of patients in which radiotherapy is delayed for wound complications.

    Measured: The first postoperative month

  14. Length of hospital stay

    Measured: The first postoperative 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2014 (estimated)
  2. Study startMar 2013
  3. Primary completionMar 2015
  4. Study completionMay 2015

Why it stopped: Difficulty in recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02153593
Sponsor's protocol ID
IIBSP-EVI-2011-138
Other IDs
EC11-340, 2011-006276-40
Acronym
TRANEXTUM
Status last verified
Sep 2016
First submitted
27 May 2014
Last updated
20 Sep 2016
Results posted
No
Data monitoring committee
No

Publications

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Tranexamic Acid, Fibrin glue and Electrocauterization in people with Blood Loss and Bone Tumour, run by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau at 3 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Difficulty in recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total blood loss (mL) in the postoperative period (time frame: The first postoperative 48h). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02153593, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Sep 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in