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Postoperative Bleeding Prevention in Massive Bone Tumour Resection (TRANEXTUM)

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ClinicalTrials.gov Identifier: NCT02153593
Recruitment Status : Terminated (Difficulty in recruitment)
First Posted : June 3, 2014
Last Update Posted : September 20, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Blood Loss Bone Tumour Drug: Tranexamic Acid Drug: Fibrin glue Procedure: Electrocauterization Phase 3

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Study Type : Interventional  (Clinical Trial)
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 : March 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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




Primary Outcome Measures :
  1. Total blood loss (mL) in the postoperative period [ Time Frame: 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 [ Time Frame: The first postoperative 2 weeks ]
  2. Units of blood transfused [ Time Frame: The first postoperative 2 weeks ]
  3. Proportion of patients with wound infection [ Time Frame: The first postoperative month ]
  4. Proportion of patients with wound dehiscence [ Time Frame: The first postoperative month ]
  5. Proportion of patients with reoperation for wound complications [ Time Frame: The first postoperative month ]
  6. Deep venous thrombosis [ Time Frame: The first postoperative 2 weeks ]
  7. Proportion of patients with seroma [ Time Frame: The first postoperative month ]
  8. Postoperative pain related with the surgery [ Time Frame: The first postoperative week ]
  9. Tumoral local relapse rate [ Time Frame: The first postoperative month ]
  10. Tumoral systemic dissemination rate [ Time Frame: The first postoperative month ]
  11. Mortality [ Time Frame: The first postoperative month ]
  12. Proportion of patients in which chemotherapy is delayed for wound complications [ Time Frame: The first postoperative month ]
  13. Proportion of patients in which radiotherapy is delayed for wound complications. [ Time Frame: The first postoperative month ]
  14. Length of hospital stay [ Time Frame: The first postoperative 2 weeks ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153593


Locations
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Spain
Hospital Universitario de Cruces
Barakaldo,, Vizcaya, Spain, 48903
Hospital Universitario de San Juan de Alicante
Alicante, Spain, 03550
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
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Principal Investigator: Ana Peiró, MD Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

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.

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Responsible Party: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
ClinicalTrials.gov Identifier: NCT02153593     History of Changes
Other Study ID Numbers: IIBSP-EVI-2011-138
EC11-340 ( Other Grant/Funding Number: Ministry of Health and Social Policy 2011 )
2011-006276-40 ( EudraCT Number )
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: September 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:
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Hemorrhage
Bone Neoplasms
Postoperative Hemorrhage
Pathologic Processes
Neoplasms by Site
Neoplasms
Bone Diseases
Musculoskeletal Diseases
Postoperative Complications
Tranexamic Acid
Fibrin Tissue Adhesive
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants