跳至主要内容
临床试验/CTRI/2019/05/019147
CTRI/2019/05/019147已完成不适用

To study the incidence and severity of endobronchial bleeding during Transbronchial lung biopsy (TBLB) procedure in patients without known clinical risk factors for increased bleeding: A Prospective observational study.

Fluid Research Fund1 个研究点 分布在 1 个国家目标入组 436 人开始时间: 2019年5月16日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
436
试验地点
1
主要终点
To study the incidence and severity of endobronchial bleeding during Transbronchial lung biopsy (TBLB) procedure.

研究概览

简要总结

Transbronchial lung biopsy (TBLB) is performed duringflexible bronchoscopy in order to sample tissues. It is useful in patients withlocalized lung lesions, fungal or mycobacterial infections and in lungmalignancy. Although the procedure is relatively safe, complications such aspneumothorax and hemorrhage have been reported following TBLB. Currentguidelines do   not recommend routinepre-procedural studies of coagulation parameters, unless they are known or arelikely to have coagulation abnormalities. However, in CMC, we routinely screenall our patients. It is believed that it would result in reduction of bleedingrisk, but there is no evidence to support this practice.  Therefore, we want to assess if our protocolfor routine screening is providing added benefit to the patients in decreasingthe post procedural bleeding.

For our study, we intend to identify patients with knownclinical risk factors for increased bleeding and follow the recommendedprotocol of screening them for coagulation abnormalities, and if present andwhen required, to obtain clearance for procedure from the clinicalhematologists prior to the procedure. If recommended, they will be given bloodproducts prior to the procedure. These patients will be excluded from our study.

The patients who do nothave clinical risk factors will be recruited. Coagulation parameters will   be measured in these subjects. Theprocedures in these patients will be monitored and measurement of bleeding and all other relevant variables will beobtained. The physician doing the bronchoscopy procedure will be blinded to coagulationparameters of both arms. The amount of bleeding will be quantified (in grams/dlof Hemoglobin) as well as interpreted as mild,moderate and severe bleeding by the bronchoscopist. The frequency and quantity of bleed in group of patientswith abnormal bleeding parameters will be compared with those with normalbleeding parameters.We will also look forother possible etiological causes of increase risk of bleeding like PulmonaryHypertension, history of Aspirin intake, Vasculitis, Cavitating lesions, SVCsyndrome, multiple biopsies from 1 to 3 segment vs more than 3 segments, 3 to 5biopsy pieces versus more than 5 biopsy pieces etc.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • All male and female patients above the age of 18 years presenting to the department of Pulmonary Medicine department of CMC for Transbronchial Lung biopsy.

排除标准

  • Known bleeding diathesis -Pregnant women -Thrombocytopenia -Chronic Kidney Disease -Chronic Liver Disease patients -Patients on Chemotherapy -Post Lung transplant -History of significant bleeding -post operative or trauma -History of severe epistaxis, GI bleed, hematuria, menorrhagia, petechiae, -Treatment with Anticoagulants -Patients in sepsis with shock or disseminated intravascular coagulation -Patients with low respiratory reserve -All patients who do not consent to the study.

结局指标

主要结局

To study the incidence and severity of endobronchial bleeding during Transbronchial lung biopsy (TBLB) procedure.

时间窗: May 2019 to June 2020

次要结局

  • 1.To assess the etiology of moderate to severe endobronchial bleeding in patients undergoing transbronchial biopsy procedure, in the department of pulmonary medicine.(2.To find the difference in proportion of patients with significant endobronchial bleeding during TBLB procedure performed for different lung pathologies.)

研究者

发起方
Fluid Research Fund
申办方类型
Research institution and hospital

研究点 (1)

Loading locations...

相似试验

To study the severity of bleeding during... | 临床试验