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临床试验/NCT07754396
NCT07754396已完成不适用

Effect of Prophylactic Tranexamic Acid Administration on Perioperative Bleeding and Thromboembolic Outcomes in Patients Undergoing Bariatric Surgery: A Retrospective Observational Cohort Study

G.Gennimatas General Hospital1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
140
试验地点
1
主要终点
Postoperative Hemoglobin Reduction

研究概览

简要总结

Postoperative bleeding is an important complication of bariatric surgery and may lead to increased morbidity, prolonged hospitalization, and higher healthcare costs. Tranexamic acid (TXA) has been shown to reduce perioperative blood loss in several surgical specialties; however, evidence regarding its effectiveness and safety in bariatric surgery remains limited.

This retrospective observational cohort study aims to evaluate the effect of prophylactic intraoperative tranexamic acid administration on perioperative bleeding in patients undergoing bariatric surgery. The primary objective is to assess the postoperative decrease in hemoglobin levels. Secondary objectives include evaluating the need for blood transfusion, length of hospital stay, and the incidence of thromboembolic complications, including deep vein thrombosis, pulmonary embolism, portal vein thrombosis, and acute coronary syndrome.

The study includes patients who underwent bariatric surgery at G. Gennimatas General Hospital between May 1, 2024, and April 30, 2026.

详细描述

This is a single-center retrospective observational cohort study including patients who underwent bariatric surgery at G. Gennimatas General Hospital between May 1, 2024, and April 30, 2026.

The study compares patients who received prophylactic intraoperative tranexamic acid with those who did not receive tranexamic acid. Demographic characteristics, comorbidities, laboratory findings, perioperative variables, and postoperative outcomes will be collected from medical records.

The primary outcome is the postoperative reduction in hemoglobin concentration following bariatric surgery.

Secondary outcomes include blood transfusion requirements, length of hospital stay, timing and type of postoperative thromboprophylaxis, and thromboembolic complications, including deep vein thrombosis, pulmonary embolism, portal vein thrombosis, and acute coronary syndrome.

Patients with known thrombophilia, coagulation disorders, chronic anticoagulant or antiplatelet therapy, previous pulmonary embolism, coronary artery disease, chronic kidney disease, or hypersensitivity to tranexamic acid will be excluded.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Adults (≥18 years of age).
  • •Patients who underwent bariatric surgery at G. Gennimatas General Hospital between May 1, 2024, and April 30,
  • •Availability of complete perioperative and postoperative medical records.

排除标准

  • •Known thrombophilia.
  • •Coagulation disorders.
  • •Chronic anticoagulant or antiplatelet therapy.
  • •Previous pulmonary embolism.
  • •Coronary artery disease.
  • •Chronic kidney disease.
  • •Known hypersensitivity to tranexamic acid.

研究组 & 干预措施

Tranexamic Acid Group

Patients undergoing bariatric surgery who received prophylactic intraoperative tranexamic acid as part of routine clinical practice.

Control Group

No Tranexamic Acid Group

结局指标

主要结局

Postoperative Hemoglobin Reduction

时间窗: 48 hours after surgery

Difference between preoperative hemoglobin concentration and postoperative hemoglobin concentration following bariatric surgery, comparing patients who received prophylactic tranexamic acid with those who did not.

次要结局

  • Blood Transfusion Requirement(Up to 4 weeks)
  • 2. Length of Hospital Stay(Up to 4 weeks)
  • Thromboembolic Complications(Up to 4 weeks)
  • Postoperative Hemoglobin at 24 Hours(24 hours after surgery)

研究者

发起方
G.Gennimatas General Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Panagiotis Chatzistavridis

Resident anesthesiologist, Department of Anesthesiology, MSC in Clinical Pharmacology

G.Gennimatas General Hospital

研究点 (1)

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