Safety Outcomes Post Kidney Biopsy – randomized clinical Evaluation of Efficacy of Desmopressin
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 454
- 试验地点
- 5
- 主要终点
- Efficacy primary outcome: Number of major and minor bleeding events in 24 h after the procedure which is defined as: • minor bleeding events: macroscopic haematuria; clinically silent hematoma in ultrasound in 24h after biopsy, decrease in haemoglobin concentration >20% in regards to initial values. • Major bleeding events: transfusion of red cells concentrate, embolisation, nephrectomy, bleeding related directly and indirectly death.
研究概览
简要总结
Assessment of safety and effectiveness desmopressin used before percutaneous needle kidney biopsy for bleeding prevention.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years old
- •Ability to provide Informed Consent
- •Qualification by nephrologist to kidney biopsy in accordance to current standards - transplanted kidney biopsy is not allowed.
- •Initial haemoglobin concentration > 8g/dl and PLT count >100 x103/µL
- •Normal range of APTT and INR
- •Blood pressure control defined as SBP<160 mmHg
- •Permitted antiplatelet/antithrombotic drugs: acetylsalicylic acid and non-fractionated or low molecular weight heparin.
- •No inflammation at the point of biopsy needle insertion
排除标准
- •Initial sodium concentration <130mmol/l
- •Pregnancy and breastfeeding
- •Anaphylactic shock after desmopressin administration (medical history)
- •Necessity of administration other anti-platelet / anti thrombotic drugs other than acetylsalicylic acid, non-fractionated heparin or low molecular weight heparin
- •Decompensated Heart failure
- •Von Willebrand disease (VWD) type II B
- •As per Investigator opinion a medical situation which may lead to increased intracranial pressure (ICP)
- •Hydronephrosis of the biopsied kidney
- •Usage of any prohibited drug before screening: ASA in dosage > 75mg per day; Vitamin K antagonist (VKA); direct oral anticoagulants (DOAC); except situation when dosage of listed above drugs will be adjusted in accordance to protocol.
结局指标
主要结局
Efficacy primary outcome: Number of major and minor bleeding events in 24 h after the procedure which is defined as: • minor bleeding events: macroscopic haematuria; clinically silent hematoma in ultrasound in 24h after biopsy, decrease in haemoglobin concentration >20% in regards to initial values. • Major bleeding events: transfusion of red cells concentrate, embolisation, nephrectomy, bleeding related directly and indirectly death.
Efficacy primary outcome: Number of major and minor bleeding events in 24 h after the procedure which is defined as: • minor bleeding events: macroscopic haematuria; clinically silent hematoma in ultrasound in 24h after biopsy, decrease in haemoglobin concentration >20% in regards to initial values. • Major bleeding events: transfusion of red cells concentrate, embolisation, nephrectomy, bleeding related directly and indirectly death.
Safety primary outcome: Hyponatremia 24 and 48 h after biopsy
Safety primary outcome: Hyponatremia 24 and 48 h after biopsy
次要结局
- Efficacy secondary outcome: Hospitalization time from kidney biopsy till discharge
- Efficacy secondary outcome: Cost-effectiveness analysis of desmopressin use
- Safety secondary outcome Frequency of AEs of special interest: • Tachycardia HR>100 BPM • Hypotension defined as SBP <90 mmHg or MAP <65 mgHg or a systolic blood pressure decrease of 40 mmHg. • Any thrombotic events
研究者
Second Department of Nephrology, Hypertensiology and Internal Medicine with Dialysis Unit
Scientific
Medical University Of Bialystok