Postoperative Bleeding Prevention in Massive Bone Tumour Resection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Blood Loss Bone Tumour

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tranexamic acid

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

Group Type EXPERIMENTAL

Tranexamic Acid

Intervention Type DRUG

1g intra-articular before closing the wound surgery

Electrocauterization

Intervention Type PROCEDURE

Coagulation blood from vessels by means of a electrocautery

Fibrin glue

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

Group Type EXPERIMENTAL

Fibrin glue

Intervention Type DRUG

5mL intra-articular before closing the wound surgery

Electrocauterization

Intervention Type PROCEDURE

Coagulation blood from vessels by means of a electrocautery

Usual hemostasia

Electrocauterization

Group Type ACTIVE_COMPARATOR

Electrocauterization

Intervention Type PROCEDURE

Coagulation blood from vessels by means of a electrocautery

Interventions

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Tranexamic Acid

1g intra-articular before closing the wound surgery

Intervention Type DRUG

Fibrin glue

5mL intra-articular before closing the wound surgery

Intervention Type DRUG

Electrocauterization

Coagulation blood from vessels by means of a electrocautery

Intervention Type PROCEDURE

Other Intervention Names

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Amchafibrin Evicel

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No