Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| EC11-340 | Other Grant/Funding Number | Ministry of Health and Social Policy 2011 | |
| 2011-006276-40 | EudraCT Number |
Not provided
Not provided
Difficulty in recruitment
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tranexamic acid | Experimental | Tranexamic acid, 1g intra-articular before closing the surgery wound |
|
| Fibrin glue | Experimental | One intra-articular dose of fibrin glue (Evicel 5mL) before closing the wound surgery |
|
| Usual hemostasia | Active Comparator | Electrocauterization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tranexamic Acid | Drug | 1g intra-articular before closing the wound surgery |
|
| 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 |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Known allergy to ATX
Allergy or known hypersensitivity to bovine proteins (aprotinin)
Liposarcomas low grade
History of thromboembolic disease or prothrombotic conditions:
Treatment with contraceptive drugs
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ana Peiró, MD | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario de San Juan de Alicante | Alicante | Alicante | 03550 | Spain | ||
| Hospital de la Santa Creu i Sant Pau |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006470 | Hemorrhage |
| D001859 | Bone Neoplasms |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D014148 | Tranexamic Acid |
| D015718 | Fibrin Tissue Adhesive |
| D003972 | Diathermy |
| ID | Term |
|---|---|
| D003509 | Cyclohexanecarboxylic Acids |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Fibrin glue | Drug | 5mL intra-articular before closing the wound surgery |
|
|
| Electrocauterization | Procedure | Coagulation blood from vessels by means of a electrocautery |
|
| 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 |
| Barcelona |
| Barcelona |
| 08025 |
| Spain |
| Hospital Universitario de Cruces | Barakaldo | Vizcaya | 48903 | Spain |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D005337 |
| Fibrin |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |