跳至主要内容
临床试验/CTRI/2020/12/029747
CTRI/2020/12/029747招募中2/3 期

Desmopressin nasal spray to decrease the bleeding complications in percutaneous kidney biopsy: a randomized controlled trial

Department of Nephrology INHS Asvini1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2020年12月12日最近更新:
适应症

试验速览

阶段
2/3 期
状态
招募中
发起方
入组人数
160
试验地点
1
主要终点
Post-biopsy Bleeding Complications, Presence of hematoma and its size

研究概览

简要总结

Renal biopsy is an essential procedure in thediagnosis of primary and secondary renal diseases. The technique hassignificantly improved over the past two decades because of the introduction ofultrasonography and automated-gun biopsy devices; however an accurate clinical,chemistry and renal ultrasound evaluation before and 24-hours post renal biopsyis necessary, because bleeding complications still occur in about 1/3 of ourprocedures, with major complications occurring in only 1.2% of patients.

Desmopressin (DDAVP) is a syntheticderivative of the anti-diuretic hormone vasopressin; therefore, theadministration of DDAVP is often accompanied by water retention, a drop inblood pressure and a secondary increase in heart rate. The haemostatic effectof DDAVP is related to an increase of vWF-factor VIII levels. DDAVP is thetreatment of choice for most patients with von Willebrand (type I) disease andhaemophilia A; moreover, the compound has been shown to be useful in a varietyof inherited and acquired hemorrhagic conditions, including, chronic liverdisease, uremia, and haemostatic defects induced by the therapeutic use ofanti-thrombotic drugs such as aspirin and ticlopidine. Finally, DDAVP has beenused as a haemostatic agent in patients undergoing surgery at major risk ofbleeding. Few studies have used desmopressin before kidney biopsy to reduce the chances of hematoma or other bleedingcomplications. However, the majority of published studies are retrospective andnon-randomized, and there is paucity of high grade evidence of the role ofdesmopressin in preventing post renal biopsy bleeding complications.

 The aim of this study is to evaluate theeffect of pre-biopsy treatment with desmopressin nasal spray  on the incidence of post-biopsy bleedingcomplications.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
12.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • •1.Blood pressure < 140/90 mmHg
  • •Normal coagulation parameters and platelet count.

排除标准

  • •Graft kidney biopsy, Patients on antiplatelets, Poorly controlled hypertension, Hydro/pyonephrosis, Any form of coagulation disorder.

结局指标

主要结局

Post-biopsy Bleeding Complications, Presence of hematoma and its size

时间窗: 12 hours and 24 hours after biopsy

次要结局

  • Variation in blood pressure 12 hours before and upto 24 hour after kidney biopsy

研究者

发起方
Department of Nephrology INHS Asvini
申办方类型
Government medical college

研究点 (1)

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