Tranexamic Acid for reduction of intra- and postoperative TRansfusion Requirements in elective Abdominal surgery: randomized controlled trial (TATRA) - KKSH-190

Martin-Luther-Universitaet Halle-Wittenberg0 个研究点目标入组 850 人开始时间: 2024年2月14日最近更新: 2024年8月21日

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•Patients =18 years, Planned elective esophagectomy, gastrectomy, colectomy, rectal resection, pancreatic resection, or hepatectomy, Adequate renal function with serum creatinine <250 µmol/L (2.82 mg/dL), Written informed consent obtained before randomization, Negative pregnancy test for women of childbearing potential within 14 days of com-mencing study treatment. Females of reproductive potential must agree to practice highly effective contraceptive measures during the study. These comprise measures with a failure rate of <1% per year; vasectomised partner, sexual abstinence (defined as refraining from heterosexual intercourse during the entire study period).

•Severe anaemia (haemoglobin concentration <8 g/dL (<5 mmol/L)) or Anaemia with haemoglobin concentration =8 to <10 g/dL (=5,0 100 beats/minute, palpi-tation etc. • Clinical signs of hypotension, e.g., resting systolic blood pressure <100 mmHg, orthostatic dysregulation etc. • Clinical signs of dyspnea, e.g., speech dyspnea, resting respiratory rate >20 breaths/min., Thrombocytopenia with platelets <60 x 109 /L, Confirmed bleeding disorder with the need for specific preventive perioperative treat-ment (e.g., factor deficiency with the need of perioperative substitution), A priori refusal of blood transfusions, Confirmed thrombophilia with a pertinent need for perioperative anticoagulation, Allergy / hypersensitivity to TXA, Recent (<30 days) thromboembolic event, History of medically confirmed convulsions, In female subjects: pregnancy or lactation.

发起方

Martin-Luther-Universitaet Halle-Wittenberg