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临床试验/NCT00816127
NCT00816127已完成不适用

Intranasal DDAVP in Preventing Bleeding During Dental Extraction in Cirrhotic Patients

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2003年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
1
主要终点
Necessity of rescue blood transfusion in patients who received DDAVP or blood transfusion prior to dental extraction.

研究概览

简要总结

The purpose of this study is to investigate how effective and cost saving 1-deamino-8-D-arginine vasopressin (desmopressin, DDAVP) is as opposed to the transfusion of blood products in preventing bleeding after teeth extraction in persons with severe liver disease being evaluated for liver transplant.

详细描述

Liver cirrhosis is associated with dysregulation of the coagulation system resulting in an increased bleeding tendency in cirrhotic patients. The treatment approach to offset these abnormalities may involve transfusion with fresh frozen plasma (FFP) and platelets. Fluid overload may become a concern as the large amount of FFP (10-20mls/kg or >1,500ml) required to achieve the hemostatic effect could be contraindicated in some patients. Furthermore, repeated platelet transfusion induces alloimmunization and refractoriness to new transfusion, which is an important issue in patients on the waiting list for liver transplantation in which HLA-matched and cross-matched platelets may be required. Non-transfusional drugs that help to stop bleeding have been used in patients with congenital bleeding disorders. 1-deamino-8-D-arginine vasopressin (DDAVP, Desmopressin), a synthetic analogue of the antidiuretic hormone, L-arginine, has been used as a non-transfusional form of replacement therapy in a variety of congenital and acquired bleeding disorders. Through unknown mechanisms, DDAVP shortens the prolonged bleeding times of cirrhotic patients despite the high plasma concentrations of Factor VIII and von Willebrand factor sound in chronic liver disease, indicating that it might be useful as a prophylactic treatment in cirrhotic patients undergoing minimally invasive procedures, i.e. dental extraction.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult patients with biopsy-proven liver cirrhosis or clinical/radiological evidence of cirrhosis, requiring dental extraction
  • platelet count of 30,000-50,000/microL and/or INR 2.0-3.0

排除标准

  • the presence of other bleeding disorders besides cirrhosis such as renal dysfunction (creatinine > 2.0) or HIV
  • receipt of blood transfusion within 2 weeks prior to study
  • recent acute decompensation of liver cirrhosis
  • malignancy excluding hepatocellular carcinoma in the absence of portal vein thrombosis
  • treatment with anti-platelet medications (aspirin, non-steroidal anti-inflammatory drugs or clopidogrel) within ten days prior to the extraction
  • documented allergy to DDAVP.

研究组 & 干预措施

1

Experimental

DDAVP

干预措施: Desmopressin (Drug)

2

Active Comparator

Standard Treatment

干预措施: blood transfusion (Biological)

结局指标

主要结局

Necessity of rescue blood transfusion in patients who received DDAVP or blood transfusion prior to dental extraction.

时间窗: 48 hours

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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