Postoperative Bleeding Prevention in Massive Bone Tumour Resection

Study Overview
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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.

Official Title
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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

Conditions
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Blood Loss, Bone Tumour

Intervention / Treatment
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* Drug: Tranexamic Acid
* Drug: Fibrin glue
* Procedure: Electrocauterization


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tranexamic acid<br>Tranexamic acid, 1g intra-articular before closing the surgery wound | Drug: Tranexamic Acid<br>* 1g intra-articular before closing the wound surgery<br>* Other names: Amchafibrin;Procedure: Electrocauterization<br>* Coagulation blood from vessels by means of a electrocautery<br>|
| Experimental: Fibrin glue<br>One intra-articular dose of fibrin glue (Evicel 5mL) before closing the wound surgery | Drug: Fibrin glue<br>* 5mL intra-articular before closing the wound surgery<br>* Other names: Evicel;Procedure: Electrocauterization<br>* Coagulation blood from vessels by means of a electrocautery<br>|
| Active Comparator: Usual hemostasia<br>Electrocauterization | Procedure: Electrocauterization<br>* Coagulation blood from vessels by means of a electrocautery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Deep venous thrombosis |  | The first postoperative 2 weeks | 
| Proportion of patients with seroma |  | The first postoperative month | 
| Postoperative pain related with the surgery |  | The first postoperative week | 
| Tumoral local relapse rate |  | The first postoperative month | 
| Tumoral systemic dissemination rate |  | The first postoperative month | 
| Mortality |  | The first postoperative month | 
| Proportion of patients in which chemotherapy is delayed for wound complications |  | The first postoperative month | 
| Proportion of patients in which radiotherapy is delayed for wound complications. |  | The first postoperative month | 
| Length of hospital stay |  | The first postoperative 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Clinical trial, Randomized, Fibrin glue, Tranexamic acid, Blood loss