NCT06622187Enrolling By Invitation4 期
Bleeding Prevention With Desmopressin for Allograft Kidney Biopsies: a Double-blind Randomized Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Bleeding events
研究概览
简要总结
The goal of this study is to evaluate the efficacy and safety of desmopressin to prevent bleeding after percutaneous renal graft biopsy in patients at high risk of bleeding.
Researchers will compare desmopressin (DDAVP) to placebo to see if the drug reduces the risk of bleeding events related to kidney biopsy.
Participants will receive intravenous desmopressin medication (100ml) or placebo (100mL of saline solution) before the kidney biopsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Kidney transplant patients with GFR <60ml/min/1,73m²
- •Need for graft biopsy as indicated by the kidney transplant medical team
- •Platelets >80.000 cells/mm³
- •Blood pressure levels controlled before the procedure
- •Normal coagulogram levels
排除标准
- •Pregnant women
- •Prior history of allergic reaction to DDAVP
- •Use of prohibitive medications in screening: warfarin, direct oral anticoagulants, unfractionated and low molecular weight heparin in full anticoagulation doses
- •History of previous blood dyscrasias
研究组 & 干预措施
Sodium Chloride
Placebo Comparator
干预措施: Sodium Chloride (Drug)
Desmopressin (DDAVP)
Experimental
干预措施: Desmopressin (DDAVP) (Drug)
结局指标
主要结局
Bleeding events
时间窗: Immediately post-biopsy until 48 hours post-biopsy
Incidence of bleeding related to the procedure
次要结局
- Major bleeding(Immediately post-biopsy until 48 hours post-biopsy)
- Minor bleeding(Immediately post-biopsy until 48 hours post-biopsy)
研究者
研究点 (1)
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