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临床试验/NCT00041782
NCT00041782终止2 期

Outpatient Treatment Of Deep Venous Thrombosis (DVT) Using Subcutaneous Dalteparin (Fragmin) In Low Risk Cancer Patients

M.D. Anderson Cancer Center1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2000年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
终止
入组人数
26
试验地点
1
主要终点
Quality of Life Survey Responses

研究概览

简要总结

Study Plan: Adult cancer patients who have a low risk profile and present with DVT will receive dalteparin 200 IU/kg subcutaneously daily (based on actual body weight with a maximum dose of 18,000 IU). Eligible patients who have signed the informed consent will be instructed on injection technique, will give themselves their first subcutaneous injection under supervision of the physician or the nurse and will be observed for a minimum of 1-2 hours prior to discharge. Patients may be admitted to an observation unit for up to 24 hours prior to discharge if medically necessary. Those patients without complications during the observation period will be given discharge instructions and an outpatient schedule to see one of the physician investigators daily for their subcutaneous injection of dalteparin, routine lab work and initiation of oral anticoagulation therapy.

Patients that are proficient in administering their own injection with dalteparin will be evaluated every other day by the physician investigator. On days of home injection, the study nurse will call the patient to check on the patient's status and to remind the patient of his/her daily injection. Patients will undergo a physical examination every other day by the physician investigator directed towards the clinically affected areas until a therapeutic response (INR 2-3) on oral warfarin has been achieved or the patient's clinical condition warrants modification of therapy with or without hospitalization. Patients will remain on study for a minimum of 5 days with at least 1 day of therapeutic oral anticoagulation.

The quality of life of the patients enrolled will be assessed by using the Modified Medical Outcome Study Short Form-20. An adapted version of the Rotterdam Symptom Checklist will be used to specifically assess patients with thrombosis. Patients will complete these two instruments at study entry, day 3, day 5 and at the end of study if different from day 5.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
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

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Dalteparin

Experimental

干预措施: Dalteparin (Fragmin) (Drug)

结局指标

主要结局

Quality of Life Survey Responses

时间窗: Collection over study period (5 years)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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