Clinical trial · Interventional
Postoperative Bleeding Prevention in Massive Bone Tumour Resection
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulty in recruitment
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Blood Loss | — | UNRESOLVED | — |
| Bone Tumour | Bone Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electrocauterization | Procedure | — | UNRESOLVED |
| Fibrin glue | Drug | — | UNRESOLVED |
| Tranexamic Acid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Tranexamic acid
- description
- Tranexamic acid, 1g intra-articular before closing the surgery wound
- interventionNames
- Drug: Tranexamic Acid
- Procedure: Electrocauterization
- type
- EXPERIMENTAL
- label
- Fibrin glue
- description
- One intra-articular dose of fibrin glue (Evicel 5mL) before closing the wound surgery
- interventionNames
- Drug: Fibrin glue
- Procedure: Electrocauterization
- type
- ACTIVE_COMPARATOR
- label
- Usual hemostasia
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- BACKGROUNDIbáñez 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.