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临床试验/NCT04860544
NCT04860544已完成不适用

Red Blood Cell Transfusion and Its Association With Vascular Pedicle Thrombosis

Fundación Universitaria de Ciencias de la Salud0 个研究点目标入组 302 人开始时间: 2013年1月16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
302
主要终点
VASCULAR PEDICLE THROMBOSIS

研究概览

简要总结

The present cohort was performed between January of 2014 and December of 2019. It included 302 free flaps conducted between January 2006 and December 2019 in the Hospital de San José and Hospital Infantil Universitario de San José in Bogotá, Colombia. Its aims were to determine whether there is an association between perioperative red blood cell transfusion and the risk of free flap vascular pedicle thrombosis. The exposure was the red blood cell transfusion therapy during the perioperative eriod, and the primary outcome was the occurrence of vascular pedicle thrombosis, which was defined as the intraoperative visualization of arterial or venous thrombosis of the vascular pedicle observed until seven days following the procedure.

As a secondary outcome, the presence of clinical signs of arterial or venous flap suffering. Red blood cell transfusion was prescribed by the attending anesthesiologist.

The methodology included data collection from medical records history, statistical analysis (incidence of thrombosis and to plot survival curves, the incidence rates calculated for every 1000 free flaps and the analysis between thrombosis and perioperative variables) by Kaplan Meier method and Cox regression models and its interpretation. The results showed that red blood cell transfusion during the perioperative period did not represent a risk for vascular pedicle thrombosis and also discarded a possible effect on the free flap survival.

详细描述

The study included patients who underwent free flap surgery between January 2006 and December 2019 in the Hospital de San José and Hospital Infantil Universitario de San José in Bogotá, Colombia. Criteria for exclusion were history of deep vein thrombosis, pulmonary embolism, systemic lupus erythematosus, antiphospholipid syndrome, hypercoagulability syndrome, and previous medication with oral or parenteral anticoagulant within the past year of the surgery. A standardized Google App for Work form was created where participant's medical records were registered. The exposure criteria were RBCT, and the primary outcome was the occurrence of VPT, which was defined as the intraoperative visualization of arterial or venous thrombosis in the vascular pedicle, observed up until seven days after the procedure. As a secondary outcome, the presence of clinical signs of arterial flap suffering (pallor, decreased capillary filling time, decreased skin turgor, , venous congestion: blue dermal bleeding, and poikilothermia). As well as the absence of blood flow measured by Doppler ultrasound that was registered from the beginning until the outcome. Different clinical characteristics were recorded such as: age, gender, body mass index (BMI), diabetes (fasting blood glucose >126 mg/dl or random glucose value >200 mg/dl), arterial hypertension (persistently high value >140/90 mmHg or use of antihypertensive medication for adequate control) anesthetic risk (ASA Classification), most recent pre-surgical hemoglobin (Hb mg/dl), most recent pre-surgical hematocrit (Ht %), anemia (Hb <12mg/dl or Hto <36% in children under 14 and women of childbearing age, Hb <13 mg/dl or Hto <39% in men over 14 or postmenopausal women), history of chemotherapy during the past year, history of radiation therapy in the flap donor or free flap recipient site In regard to the surgery performed, the following variables were analyzed: indication of procedure, free flap donor site, free flap recipient site, type of flap, whether or not other concomitant surgical procedures were being performed (oncological resections, osteosynthesis, tumor resections) and intra-operative bleeding according to the records from anesthesiologists' evaluations. The information was exported from the standardized formats to a database for statistical analysis through statistical packages R and Stata 15® licensed by the Fundación Universitaria de Ciencias de la Salud - FUCS.

The exposed group corresponded to patients who received red blood cell transfusion during the perioperative period of free flap surgery (defined as: 24 hours before, during and up to 24 hours after the procedure).

  • The unexposed group corresponded to patients who did not receive red blood cell transfusion during the perioperative period of free flap surgery (defined as: 24 hours before, during and up to 24 hours after the procedure).

研究设计

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

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

  • •The study included patients who underwent free flap surgery between January 2006 and December 2019 in the Hospital de San José and Hospital Infantil Universitario de San José in Bogotá, Colombia.

排除标准

  • •Criteria for exclusion were history of deep vein thrombosis, pulmonary embolism, systemic lupus erythematosus, antiphospholipid syndrome, hypercoagulability syndrome and previous medication with oral or parenteral anticoagulant within the past year of the surgery.

结局指标

主要结局

VASCULAR PEDICLE THROMBOSIS

时间窗: 7 DAYS

the primary outcome was the occurrence of VPT, which was defined as the intraoperative visualization of arterial or venous thrombosis of the vascular pedicle observed until seven days following the procedure

次要结局

  • arterial or venous non-thrombotic vascular complications in the flap(7 DAYS)

研究者

发起方
Fundación Universitaria de Ciencias de la Salud
申办方类型
Other
责任方
Sponsor

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