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临床试验/NCT04475497
NCT04475497终止不适用

Role of Blood Management in Optimizing Perioperative Outcomes in Patients With Secondary Anemia Undergoing Hysterectomy or Myomectomy for Abnormal Uterine Bleeding: A Proposed Randomized Control Trial

The Cleveland Clinic2 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2020年7月24日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
22
试验地点
2
主要终点
Change in hemoglobin level

研究概览

简要总结

There is currently limited information regarding the role of blood management in the benign gynecologic population and specifically, in patients who are scheduled to undergo surgery for fibroids and/or abnormal uterine bleeding. A thorough search through PubMed and clinicaltrials.gov did not reveal any studies on this issue. In 2019 at CCF only 2% of gyn patients at Main Campus were referred to blood management, but 12.6% of the main campus gyn population had a Hb of <10.0 g/dL. The overall goal of this study is to evaluate the role of preoperative blood management in optimizing surgical outcomes by reducing the co-morbidities associated with postoperative blood transfusion.

详细描述

Title : Role of blood management in optimizing perioperative outcomes in patients with secondary anemia undergoing hysterectomy or myomectomy for abnormal uterine bleeding: A Proposed Randomized Control Trial

I. Background/Introduction:

According to the World Health Organization (WHO), 30.2 % of the world's population of nonpregnant women are anemic, with a higher percentage of anemia being encountered in patients seeking surgical management of abnormal uterine bleeding (AUB). Age, gender, socioeconomic factors, nutrition, and certain pathologic states are associated with iron depletion and associated iron deficiency anemia. Uterine fibroid (or leiomyoma) is the most common diagnosis associated with hysterectomy, accounting for approximately 31% of all procedures performed. Abnormal uterine bleeding and endometriosis are the second and third most common diagnoses associated with hysterectomy, explaining 14% and 11%, respectively. Based on the diagnoses recorded in the medical record by providers, 48.7% of patients were presumed to have dysfunctional uterine bleeding (DUB) and 9% were presumed to have bleeding secondary to uterine fibroids. In this population of women with AUB, 350 (92.3%) had a hemoglobin concentration recorded. Thirty-five percent were anemic with a hemoglobin of <12g/dL and 13.7% had moderate to severe anemia with a hemoglobin of <10 g/dL.

In addition to the high incidence of secondary anemia in patients with abnormal uterine bleeding and fibroids, surgeries for abnormal uterine bleeding and fibroids such as hysterectomy and myomectomy can involve a significant blood loss. The overall rate of postoperative blood transfusion for hysterectomy in the cited study was 13.3%. The need for packed red blood cell transfusion is one of the known complications of surgery and is increased in women who are noted to be anemic preoperatively. Blood transfusions are associated with increased adverse surgical outcomes. Higher rates of morbidity and mortality have been reported in patients receiving one unit of packed red blood cells compared with patients who did not undergo transfusion. The WHO recommends, in compliance with their guide for optimal clinical use, "that before surgery every reasonable measure should be taken to optimize the patient's own blood volume" . Pre-operative hemoglobin less than 10.6 g/dL versus greater than or equal to 13.1 g/dL had five times the odds of transfusion.

Anemia is a modifiable risk factor that can be assessed and optimized pre-operatively. Prior studies have evaluated preoperative blood management strategies in oncology patients, patients undergoing general surgery procedures, and orthopedic surgery. A systematic review of the management of perioperative anemia showed varying results in change in hemoglobin levels after blood management intervention, but all studies were able to show a decrease in postoperative blood transfusions. A randomized control trial evaluating oral iron supplementation preoperatively in patients undergoing colorectal surgery reported reduced blood transfusion rates in the group receiving this intervention. Froessler et al studied perioperative IV iron intervention in patients undergoing major abdominal surgery in a randomized control trial with using blood transfusions as a primary endpoint. They concluded that perioperative IV iron reduced the need for blood transfusion and was also associated with higher postoperative hemoglobin and shorter hospital stay. A blood management protocol implemented in the perioperative period also noted a decrease in perioperative blood transfusion and postoperative anemia in the orthopedic population. The interventions used in their blood protocol management included erythropoietin, ferric carboxymaltose, and tranexamic acid.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Anemic patients (defined as Hgb < 11g/dL within 30 days of initial consult visit)
  • Greater than 18-years of age with abnormal uterine bleeding or fibroids
  • Scheduled for gynecologic surgery (myomectomy or hysterectomy by laparoscopic, robotic, vaginal or open routes)

排除标准

  • Malignancy
  • Pregnancy
  • Sickle cell anemia or other blood dyscrasias
  • Women who received blood transfusions within 30 days prior to surgery
  • Women receiving EPO therapy
  • Women who have undergone gastric bypass surgery
  • Women on therapeutic/full anticoagulation
  • Patients undergoing hysteroscopic myomectomy alone without will not be included in the study

结局指标

主要结局

Change in hemoglobin level

时间窗: 4-months

Preoperative hemoglobin minus postoperative hemoglobin

次要结局

  • Operative time(1-day)
  • Blood loss(1-day)
  • Length of hospital stay(3-days)
  • Perioperative transfusion rate(3-days)
  • Intraoperative complications(30-days)
  • Patient satisfaction rating scale: PATSAT - 35 item questionnaire(4-months)
  • Quality of health and recovery: RAND Healthcare -36 item questionnaire(4-months)
  • Quantity of IV iron(4-months)
  • Days on PO iron therapy(4-months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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