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临床试验/ACTRN12612001062819
ACTRN12612001062819招募中1 期

A randomized controlled trial (RCT) of a new monovalent antivenom (ICP Papuan taipan antivenom) for the treatment of Papuan taipan (Oxyuranus scutellatus) envenoming in Papua New Guinea to measure safety, minimum dose and effectiveness in the prevention of neurotoxic paralysis, arrest of coagulopathy and other effects of envenoming.

niversity of Melbourne0 个研究点目标入组 388 人开始时间: 2012年10月4日最近更新:
适应症

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
388

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
2 Years 至 o limit(—)
性别
All

入选标准

  • (i). Only patients who present to the Emergency Department within four (4) hours post-bite;
  • (ii). Who meet predetermined minimal criteria for the diagnosis of taipan envenoming;
  • (iii). Give informed consent; and,
  • (iv). Do not have any of the predetermined exclusion criteria, will be enrolled.
  • (v). Patients who present more than four (4) hours post-bite, or who have any other exclusion
  • criteria, will be treated according to the current national protocol.

排除标准

  • (i). All patients who present to hospital more than four (4) hours post-bite;
  • (ii). Any patients with clinical evidence of intracranial haemorrhage;
  • (iii). Any patient with progressive oropharyngeal paralysis with partial or complete loss of airway
  • patency, including any patient requiring endotracheal intubation;
  • (iv). Any patient with significant known co-morbidities (such as active TB, AIDS, diabetes
  • requiring medication or ischaemic heart disease);
  • (v). Any patient who has already received treatment with antivenom at another health facility.

研究者

发起方
niversity of Melbourne

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