2023-503613-29-00招募中2 期
Efficacy and safety of octreotide in laparoscopic hepatectomy surgery: effect on blood loss, need for vasoactive drugs, transfusion requirement.
University Clinic Of Navarra1 个研究点 分布在 1 个国家目标入组 62 人开始时间: 2023年6月20日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- The main objective of the trial is the reduction of intraoperative bleeding, which will be measured through milliliters of blood lost at the end of surgery, decrease in hemoglobin, hematocrit, platelets and fibrinogen values.
研究概览
简要总结
Observe the effects on intraoperative bleeding (measured in ml of blood lost) associated with the intraoperative administration of octreotide in laparoscopic hepatectomy surgery in relation to placebo.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with hepatic lesions who are going to undergo laparoscopic hepatectomy.
- •The patient must be between 18 and 80 years old.
- •The patient, or his/her representative, has given his/her consent to participate in the study.
- •The patient must, in the opinion of the investigator, be able to comply with all the requirements of the clinical trial.
- •The patient must not be allergic to the drug.
排除标准
- •History of hypersensitivity to the drug to be administered
- •Children under 18 years of age.
- •Urgent intervention.
- •Intervention performed in an open manner (not laparoscopic).
- •Patient's refusal to participate in the study.
- •Contraindication to receive octreotide.
- •Women of childbearing age (those women who are in the period between menarche and menopause). Having to present a negative pregnancy test to take part in the study.
- •Pregnant or lactating women given the absence of studies of this drug in this patient profile.
结局指标
主要结局
The main objective of the trial is the reduction of intraoperative bleeding, which will be measured through milliliters of blood lost at the end of surgery, decrease in hemoglobin, hematocrit, platelets and fibrinogen values.
The main objective of the trial is the reduction of intraoperative bleeding, which will be measured through milliliters of blood lost at the end of surgery, decrease in hemoglobin, hematocrit, platelets and fibrinogen values.
次要结局
- Changes in heart rate and blood pressure during surgery.
- Need for transfusion of blood products during surgery and later during the immediate perioperative 24-72h.
- Need for the use of vasoactive drugs during surgery and if needed, we will indicate when they can be withdrawn.
- Number of clampings and their duration with monitoring of hemodynamic stability during surgery.
- Hepatic function and its recovery after surgery, control of hemogram and coagulation after 24h, at discharge and at 3 months.
- Evaluation of admissions after surgery up to three months later related to any post-surgical complication.
研究者
UCEC
Scientific
University Clinic Of Navarra
研究点 (1)
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