Patients with bone tumor undergoing massive resection.
Conditions
Sponsors
Institut de Recerca Hospital Sant Pau
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients over 18 years 2) Bone tumor (primary or metastatic, benign or malignant) alocated in the extremities, or the pelvic or shoulder girdles. 3) Massive or block resection of bone tumor. 4) Signature of the patient's informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 115 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1) Allergy to tranexamic acid or fibrin glue 2) Background compatible with thromboembolic disease: ? Stroke ? Ischemic heart disease ? Deep vein thrombosis and / or superficial ? Pulmonary thromboembolism ? Peripheral arterial vascular disease ? Iron therapy in post-operative period ? Use of recuperatorsof blood during surgery ? Patients with thrombogenic arrhythmias ? Patients with prosthetic heart ? Coagulation disorders prothrombotic ? Treatment with contraceptive drugs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess if the fibrin glue or the topic tranexamic acid reduce at least 35% the blood losses after surgery with respect to the normal haemostasia in patients undergoing massive bone resection.;Secondary Objective: 1. Proportion of patients requiring blood transfusion in the postoperative period 2. Preoperative and postoperative hemoglobin 3. Number of blood transfusions 4. Number of units of blood transfusion administered 5. Incidence of wound infection 6. Incidence of seroma formation 7. Pain patient's at the surgical wound 8. Days in hospital 9. Side effects associated with interventions 10. Local recurrence rate 11. Distant metastasis rate;Primary end point(s): Amount (ml) of blood loss after surgery quantified the first 48 hours postoperatively.;Timepoint(s) of evaluation of this end point: First postoperative 48 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Related to bleeding: ? Proportion of patients requiring blood transfusion in the postoperative period ? Units of blood transfused ? Preoperative haemoglobin: for 12 h before surgery ? Postoperative haemoglobin: 24 hours and 5 days . 2. Complications related to surgical wound ? Proportion of patients with wound infection ? Proportion of patients with wound dehiscence ? Proportion of patients in the surgical seroma ? Proportion of patients with re-operation for wound complications ? Patient's postoperative pain (Visual Analogical Scale) 3. Related to drug safety evaluation: 4. Process-related cancer ? Local recurrence rate ? Rate of distant spread ? Survival rate ? Proportion of patients who delayed the start of adjuvant chemotherapy ? Proportion of patients in which delays the onset of postoperative radiotherapy 5. Other variables: ? Incidence of deep vein thrombosis on admission ? Time in hospital ? Mortality;Timepoint(s) of evaluation of this end point: The postoperative days, 3 and 6 weeks after the intervention. | — |
Countries
Spain
Contacts
Public ContactRomy Rodriguez
Institut de Recerca HSCSP
Outcome results
None listed