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TRANEXTUM: Postoperative Bleeding Prevention in Massive Bone Tumour Resection

Sponsor
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau (Other)
Overall Status
Terminated
CT.gov ID
NCT02153593
Collaborator
(none)
56
Enrollment
3
Locations
3
Arms
26
Duration (Months)
18.7
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Tranexamic Acid
  • Drug: Fibrin glue
  • Procedure: Electrocauterization
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
56 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date :
Mar 1, 2013
Actual Primary Completion Date :
Mar 1, 2015
Actual Study Completion Date :
May 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tranexamic acid

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

Drug: Tranexamic Acid
1g intra-articular before closing the wound surgery
Other Names:
  • Amchafibrin

    • Procedure: Electrocauterization
    Coagulation blood from vessels by means of a electrocautery
    Experimental: Fibrin glue

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

    Drug: Fibrin glue
    5mL intra-articular before closing the wound surgery
    Other Names:
  • Evicel

    • Procedure: Electrocauterization
    Coagulation blood from vessels by means of a electrocautery
    Active Comparator: Usual hemostasia

    Electrocauterization

    Procedure: Electrocauterization
    Coagulation blood from vessels by means of a electrocautery

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Proportion of patients requiring blood transfusion [The first postoperative 2 weeks]

    2. Units of blood transfused [The first postoperative 2 weeks]

    3. Proportion of patients with wound infection [The first postoperative month]

    4. Proportion of patients with wound dehiscence [The first postoperative month]

    5. Proportion of patients with reoperation for wound complications [The first postoperative month]

    6. Deep venous thrombosis [The first postoperative 2 weeks]

    7. Proportion of patients with seroma [The first postoperative month]

    8. Postoperative pain related with the surgery [The first postoperative week]

    9. Tumoral local relapse rate [The first postoperative month]

    10. Tumoral systemic dissemination rate [The first postoperative month]

    11. Mortality [The first postoperative month]

    12. Proportion of patients in which chemotherapy is delayed for wound complications [The first postoperative month]

    13. Proportion of patients in which radiotherapy is delayed for wound complications. [The first postoperative month]

    14. Length of hospital stay [The first postoperative 2 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital Universitario de Cruces Barakaldo, Vizcaya Spain 48903
    2 Hospital Universitario de San Juan de Alicante Alicante Spain 03550
    3 Hospital de la Santa Creu i Sant Pau Barcelona Spain 08025

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Ana Peiró, MD, Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
    ClinicalTrials.gov Identifier:
    NCT02153593
    Other Study ID Numbers:
    • IIBSP-EVI-2011-138
    • EC11-340
    • 2011-006276-40
    First Posted:
    Jun 3, 2014
    Last Update Posted:
    Sep 20, 2016
    Last Verified:
    Sep 1, 2016
    Keywords provided by Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
    Clinical trial
    Randomized
    Fibrin glue
    Tranexamic acid
    Blood loss
    Additional relevant MeSH terms:
    Bone Neoplasms
    Hemorrhage
    Postoperative Hemorrhage
    Tranexamic Acid
    Fibrin Tissue Adhesive

    Study Results

    No Results Posted as of Sep 20, 2016