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临床试验/NCT05517590
NCT05517590已完成不适用

Effect of Intravenous Tranexamic Acid Plus Intramyometrial Desmopressin on Blood Loss During Laparoscopic Myomectomy: Randomized, Double-blind, Placebo-controlled Trial

Acibadem University1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2022年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
102
试验地点
1
主要终点
Perioperative blood loss

研究概览

简要总结

To evaluate the effect of intravenous tranexamic acid plus intramyometrial desmopressin administration on perioperative blood loss and blood transfusion need in laparoscopic myomectomy operation.

详细描述

Although complication rates such as bleeding are observed to be low in surgeries performed by experienced surgeons, sometimes severe bleeding that may require emergency blood transfusion can be encountered during myomectomy operation. Therefore, various medical treatments such as vasopressin, misoprostol, ascorbic acid are still being sought to reduce the amount of intraoperative bleeding. Tranexamic acid is a lysine-derived drug with an antifibrinolytic effect, which has been used for a long time, especially in orthopedic and cardiovascular surgeries, to stop bleeding and reduce the need for blood transfusions, and is often well tolerated and has few side effects. It has a good safety profile with the Food and Drug Administration (FDA) Pregnancy Category B and is a drug frequently used in postpartum hemorrhage. It is also used to reduce bleeding in bleeding observed in many gynecological surgeries such as hypermenorrhea, bleeding in intrauterine device application and cervical conization. In the investigator's clinic, intramyometrial desmopressin administration is routinely used in most cases. Although the application of various intraoperative medical treatments in laparoscopic myomectomies has been examined in the literature, there are not enough prospective studies investigating the administration of desmopressin and intravenous tranexamic acid. In the investigator's study, investigators plan to evaluate the effect of the combined use of these two drugs on intraoperative bleeding and the need for blood transfusion compared to placebo.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

The patient, the surgeon and the assistant that will collect the data will be masked about the patient's study group.

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Healthy volunteer female patients over the age of 18 who will undergo laparoscopic myomectomy in our clinic will be included in our study.

排除标准

  • Patients who are planned to undergo different surgery along with myomectomy
  • Those with a diagnosis and suspicion of malignancy
  • Those with a history of thromboembolic disease
  • Those with cardiac, hepatic or renal disease
  • Those with a body mass index of 30 and above
  • Patients with abnormal coagulation test results
  • Patients using anticoagulants
  • Those who use drugs or diseases that may affect coagulation (serum creatinine > 1.5 mg/dL)
  • Those allergic to tranexamic acid

研究组 & 干预措施

Tranexamic acid and group (Group I)

Active Comparator

In Group I, 1 gram of tranexamic acid will be diluted into 100 ml of saline solution and administered at a rate of 100 ml/hr 10 minutes before the skin incision time.

干预措施: Tranexamic acid (Drug)

Saline group (Group II)

Placebo Comparator

Group II placebo will be administered to the control group, and 100 ml of saline solution will be administered at a rate of 100 ml/hr 10 minutes before the skin incision time.

干预措施: Saline (Drug)

结局指标

主要结局

Perioperative blood loss

时间窗: At the end of the surgery.

The amount of perioperative bleeding will be calculated by measuring the blood volume in the suction device and subtracting the irrigation fluid from the total amount.

Preoperative and postoperative hemoglobin change

时间窗: On postoperative day 0 and day 2

Preoperative and postoperative hemoglobin values will be recorded.

次要结局

  • Need for postoperative blood transfusion(Postoperative day 1)
  • Operation time(At the end of the operation.)
  • Postoperative thrombosis symptoms(At postoperative first week and 3rd month.)

研究者

发起方
Acibadem University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Esra Ozbasli

Assistant Professor

Acibadem University

研究点 (1)

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