EUCTR2016-003214-27-ES进行中（未招募）1 期
Randomized, double-blind, 3-arm trial to evaluate the impact of blood loss following administration of three tranexamic acid regimens in patients undergoing bone or soft tissue sarcomas. - UTOTXA_2016
Irene Barrientos Ruiz0 个研究点开始时间: 2016年12月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •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
- •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
排除标准
- •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
- •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
- •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)
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