Oncological orthopedic surgery (bone and soft tissue sarcomas in the appendicular skeleton, pelvis and scapular girdle). MedDRA version: 15.1 Level: HLGT Classification code 10041299 Term: Soft tissue sarcomas System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 19.0 Level: HLT Classification code 10039498 Term: Bone sarcomas System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Amchafibrin
Product Name: Amchafibrin
Product Code: 53939
Pharmaceutical Form: Concentrate and solvent for solution for injection
INN or Proposed INN: TRANEXAMIC ACID
Other descriptive nam
Sponsors
Irene Barrientos Ruiz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female patients older than 12 years. 2) Patients with a diagnosis of bone sarcoma or soft tissue sarcoma of more than 10 cm in their largest diameter, appendicular skeleton, pelvis and scapular girdle. 3) Planned surgical intervention in our center (La Paz University Hospital) with the intention of conservative surgery of the limb by means of extensive tumor resection and reconstruction if necessary for soft tissue and / or bone. 4) Preoperative hemoglobin (at the pre-anesthetic assessment, maximum 30 days prior to inclusion) of at least 11 g / dL. 5) The patient or his / her legal representative (if applicable) has understood the study procedures and signed the informed consent. 6) If participant between 12 and 17 years old, the patient must give his assent to participate in the study. Are the trial subjects under 18? yes Number of subjects for this age range: 30 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 95 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25 ;Inclusion criteria: 1) Male or female patients older than 12 years. 2) Patients with a diagnosis of bone sarcoma or soft tissue sarcoma of more than 10 cm in their largest diameter, appendicular skeleton, pelvis and scapular girdle. 3) Planned surgical intervention in our center (La Paz University Hospital) with the intention of conservative surgery of the limb by means of extensive tumor resection and reconstruction if necessary for soft tissue and / or bone. 4) Preoperative hemoglobin (at the pre-anesthetic assessment, maximum 30 days prior to inclusion) of at least 11 g / dL. 5) The patient or his / her legal representative (if applicable) has understood the study procedures and signed the informed consent. 6) If participant between 12 and 17 years old, the patient must give his assent to participate in the study. Are the trial subjects under 18? yes Number of subjects for this age range: 30 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 95 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25 ;Inclusion criteria: 1) Male or female patients older than 12 years. 2) Patients with a diagnosis of bone sarcoma or soft tissue sarcoma of more than 10 cm in their largest diameter, appendicular skeleton, pelvis and scapular girdle. 3) Planned surgical intervention in our center (La Paz University Hospital) with the intention of conservative surgery of the limb by means of extensive tumor resection and reconstruction if necessary for soft tissue and / or bone. 4) Preoperative hemoglobin (at the pre-anesthetic assessment, maximum 30 days prior to inclusion) of at least 11 g / dL. 5) The patient or his / her legal representative (if applicable) has understood the study procedures and signed the informed consent. 6) If participant between 12 and 17 years old, the patient must give his assent to participate in the study. Are the trial subjects under 18? yes Number of subjects for this age range: 30 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 95 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: 1) Known allergy or contraindication to ATX 2) Sarcomas with preoperative intention other than conservative surgery of the limb by wide resection (low grade soft tissue sarcomas with marginal intention, sarcomas requiring radical resection / amputation or bone sarcomas intended for extended intralesional resection). 3) Radical (amputation) programmed surgery. 4) The patient has any of the following comorbidities: - Severe ischemic heart disease (Class III and IV of the New Cork Heart Association) - Patients with history of valvulopathy. - Patients with a history of obstructive sleep apnea syndrome - History of severe COPD (grade III, IV) - History of seizures - Severe renal dysfunction (Creatinine greater than 2mg / dl in male and 1.8g / dl in women in preoperative analysis, maximum 30 days prior to inclusion) - Severe hepatic dysfunction (Child-Pugh grade C) 5) Coagulopathy identified in the preoperative period (maximum 30 days prior to inclusion), at least 1 of the following: - Platelet count less than 40,000 / mm3 - International normalized ratio (INR) greater than 1.4 - Prolonged thromboplastin time (aPTT): greater than 1.4 times normal. 6) History of arterial or venous thromboembolic disease 7) History of hematopoietic, hemorrhagic and thrombogenic blood dyscrasias. 8) Retinopathy (limitation of the visual field and distortion in the perception of color) 9) Women of childbearing age with a positive urine pregnancy test the day before surgery. 10) Female patients who are breastfeeding 11) Male and female patients should agree to use highly effective contraceptive methods from the time of signing informed consent and up to at least 7 days after the completion of the study ;Exclusion criteria: 1) Known allergy or contraindication to ATX 2) Sarcomas with preoperative intention other than conservative surgery of the limb by wide resection (low grade soft tissue sarcomas with marginal intention, sarcomas requiring radical resection / amputation or bone sarcomas intended for extended intralesional resection). 3) Radical (amputation) programmed surgery. 4) The patient has any of the following comorbidities: - Severe ischemic heart disease (Class III and IV of the New Cork Heart Association) - Patients with history of valvulopathy. - Patients with a history of obstructive sleep apnea syndrome - History of severe COPD (grade III, IV) - History of seizures - Severe renal dysfunction (Creatinine greater than 2mg / dl in male and 1.8g / dl in women in preoperative analysis, maximum 30 days prior to inclusion) - Severe hepatic dysfunction (Child-Pugh grade C) 5) Coagulopathy identified in the preoperative period (maximum 30 days prior to inclusion), at least 1 of the following: - Platelet count less than 40,000 / mm3 - International normalized ratio (INR) greater than 1.4 - Prolonged thromboplastin time (aPTT): greater than 1.4 times normal. 6) History of arterial or venous thromboembolic disease 7) History of hematopoietic, hemorrhagic and thrombogenic blood dyscrasias. 8) Retinopathy (limitation of the visual field and distortion in the perception of color) 9) Women of childbearing age with a positive urine pregnancy test the day before surgery. 10) Female patients who are breastfeeding 11) Male and female patients should agree to use highly effective contraceptive methods from the time of signing informed consent and up to at least 7 days after the completion of the study ;Exclusion criteria: 1) Known allergy or contraindication to ATX 2) Sarcomas with preoperative intention other than conservative surgery of the limb by wide resection (low grade soft tissue sarcomas with marginal intention, sarcomas requiring radical resection / amputation or bone sarcomas intended for extended intralesional resection). 3) Radical (amputation) programmed surgery. 4) The patient has any of the following comorbidities: - Severe ischemic heart disease (Class III and IV of the New Cork Heart Association) - Patients with history of valvulopathy. - Patients with a history of obstructive sleep apnea syndrome - History of severe COPD (grade III, IV) - History of seizures - Severe renal dysfunction (Creatinine greater than 2mg / dl in male and 1.8g / dl in women in preoperative analysis, maximum 30 days prior to inclusion) - Severe hepatic dysfunction (Child-Pugh grade C) 5) Coagulopathy identified in the preoperative period (maximum 30 days prior to inclusion), at least 1 of the following: - Platelet count less than 40,000 / mm3 - International normalized ratio (INR) greater than 1.4 - Prolonged thromboplastin time (aPTT): greater than 1.4 times normal. 6) History of arterial or venous thromboembolic disease 7) History of hematopoietic, hemorrhagic and thrombogenic blood dyscrasias. 8) Retinopathy (limitation of the visual field and distortion in the perception of color) 9) Women of childbearing age with a positive urine pregnancy test the day before surgery. 10) Female patients who are breastfeeding 11) Male and female patients should agree to use highly effective contraceptive methods from the time of signing informed consent and up to at least 7 days after the completion of the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Demonstrate the superiority of ATX use in combined versus iv and local administration alone;Secondary Objective: 1) Compare local administration versus iv administration of ATX. 2) Determine the number of blood transfusions required in each group 3) Evaluate disease-free survival, relapse-free survival, and distance disease-free survival in each group. 4) To assess the need of stimulating leukocyte colony factors, EPO and days of hospitalization in each group. 5) Evaluate the presence of postoperative hematoma on CT prior to adjuvant radiotherapy among patients with indication of radiotherapy and comparison between groups. 6) Evaluate the safety of ATX use in combined intravenous + local versus intravenous and local administration alone.;Primary end point(s): Pérdida de sangre a través del drenaje Drenofast e indirectamente mediante los valores de hemoglobina y hematocrito;Timepoint(s) of evaluation of this end point: 24 hours after surgery the milliliters of blood lost with the drenofast and at 24 hours and 5 days by analyzing the hemoglobin and hematocrit values.;Main Objective: Demonstrate the superiority of ATX use in combined versus iv and local administration alone;Secondary Objective: 1) Compare local administration versus iv administration of ATX. 2) Determine the number of blood transfusions required in each group 3) Evaluate disease-free survival, relapse-free survival, and distance disease-free survival in each group. 4) To assess the need of stimulating leukocyte colony factors, EPO and days of hospitalization in each group. 5) Evaluate the presence of postoperative hematoma on CT prior to adjuvant radiotherapy among patients with indication of radiotherapy and comparison between groups. 6) Evaluate the safety of ATX use in combined intravenous + local versus intravenous and local administration alone.;Primary end point(s): Pérdida de sangre a través del drenaje Drenofast e indirectamente mediante los valores de hemoglobina y hematocrito; | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Number of trasfusiones made in each group. • Assessment of the need for EPO and colony stimulating factors (CSF) of leukocytes. • Determination of days of hospital stay • Evaluation of the size of the postoperative hematoma in radiotherapy planning tomography. • Assessment of adverse events. • Evaluation of surgical complications • Assessment of disease-free survival and local events in long-term follow-up through imaging tests.;Timepoint(s) of evaluation of this end point: after intervention;Secondary end point(s): • Number of trasfusiones made in each group. • Assessment of the need for EPO and colony stimulating factors (CSF) of leukocytes. • Determination of days of hospital stay • Evaluation of the size of the postoperative hematoma in radiotherapy planning tomography. • Assessment of adverse events. • Evaluation of surgical complications • Assessment of disease-free survival and local events in long-term follow-up through imaging tests.;Timepoint(s) of evaluation of this end point: after intervention;Secondary end point(s): • Number of trasfusiones made in each group. • Assessment of the need for EPO and colony stimulating factors (CSF) of leukocytes. • Determination of days of hospital stay • Evaluation of the size of the postoperative hematoma in radiotherapy planning tomography. • Assessment of adverse events. • Evaluation of surgical complications • Assessment of disease-free survival and local events in long-term follow-up through imaging tests.;Timepoint(s) of evaluation of this end point: after intervention | — |
Countries
Spain
Contacts
Public ContactAntonio Diaz;Antonio Diaz;Antonio Diaz ;;
UCICEC;UCICEC;UCICEC
Outcome results
None listed