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临床试验/NCT00748072
NCT00748072已完成4 期

1-deamino 8-d-arginine Vasopressin in Percutaneous Ultrasound-guided Renal Biopsy: a Randomized Controlled Trial

University of Bari1 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2008年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
162
试验地点
1
主要终点
The Primary Outcome Measure Was the Incidence of Post-biopsy Bleeding Complications.

研究概览

简要总结

The investigators evaluated the effect of pre-biopsy treatment with 1-deamino-8-D-arginine (DDAVP) on the incidence of post-biopsy bleeding complications. This is a IV phase single centre, double blind, randomized controlled study in patients, with acute and chronic nephropathy, undergoing ultrasound-guided percutaneous renal biopsy.

详细描述

Renal biopsy is an essential procedure in the diagnosis of primary and secondary renal diseases. The technique has significantly improved over the past two decades because of the introduction of ultrasonography and automated-gun biopsy devices; however an accurate clinical, chemistry and renal ultrasound evaluation before and 24-hours post renal biopsy is necessary, because bleeding complications still occur in about 1/3 of our procedures, with major complications occurring in only 1.2% of patients. Of the data routinely collected for potential predictors of post-biopsy bleeding complications, only gender, age, and baseline partial thromboplastin time show a significant predictive value. The other variables investigated do not have any predictive value (Manno C et al, Kidney Int 2004). The majority of published studies, retrospective and non-randomized, on this topic have focused on the comparative performance of different renal biopsy techniques and types of needles, but no study has shown potential predictors of post-biopsy bleeding complications. On the other hand, the available studies have not shown any specific test to select patients with major risk of post-biopsy bleeding.

The aim of this study is to evaluate the effect of pre-biopsy treatment with DDAVP or desmopressin on the incidence of post-biopsy bleeding complications.

DDAVP is a synthetic derivative of the anti-diuretic hormone vasopressin; therefore, the administration of DDAVP is often accompanied by water retention, a drop in blood pressure and a secondary increase in heart rate. The haemostatic effect of DDAVP is related to an increase of vWF-factor VIII levels. DDAVP is the treatment of choice for most patients with von Willebrand (type I) disease and haemophilia A; moreover, the compound has been shown to be useful in a variety of inherited and acquired hemorrhagic conditions, including some congenital platelet function defects, chronic liver disease, uremia, and haemostatic defects induced by the therapeutic use of anti-thrombotic drugs such as aspirin and ticlopidine. Finally, DDAVP has been used as a haemostatic agent in patients undergoing surgery at major risk of bleeding. Disadvantages of DDAVP include reported rare thrombotic events.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Males or females > 16 and < 80 years of age.
  • Blood pressure < 140/90 mmHg.
  • Serum creatinine ≤ 1.5 mg/dl and/or creatinine clearance ≥ 60 ml/min.
  • Bleeding time, prothrombin time, partial thromboplastin time, platelets and fibrinogen in the normal range.

排除标准

  • Biopsy of transplant kidney
  • Poorly controlled hypertension
  • Single kidney
  • Renal cancer
  • Hydro/pyonephrosis
  • Renal size significantly reduced
  • Severe obesity
  • Coagulation disorder
  • Serum creatinine > 1.5 mg/dl and/or creatinine clearance < 60 ml/min

研究组 & 干预措施

Saline solution

Placebo Comparator

patients treated with 1 ml of s.c. saline solution

干预措施: saline solution (Drug)

DDAVP

Experimental

treated with DDAVP (0.3 mcg/Kg s.c.) 1 hour before renal biopsy

干预措施: DDAVP (Drug)

结局指标

主要结局

The Primary Outcome Measure Was the Incidence of Post-biopsy Bleeding Complications.

时间窗: Immediately post-biopsy and 24 hours post-biopsy.

次要结局

未报告次要终点

研究者

发起方
University of Bari
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carlo Manno

Assistant Professor, Chair of Nephrology, Unit of Nephrology, University of Bari, Bari, Italy

University of Bari

研究点 (1)

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