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