Ultrasound-sparing Strategy for Suspected DVT: A Prospective Clinical Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 199
- 试验地点
- 4
- 主要终点
- Symptomatic VTE
研究概览
简要总结
To determine the rate of thromboembolic complications (including death attributed to thromboembolic disease) in patients with a score rated as "DVT likely" on a formalized scoring system, when anticoagulation therapy is withheld on the basis of a negative comprehensive duplex ultrasound examination. Participants are followed for three months after a normal ultrasound to determine if any symptoms attributable to deep vein thrombosis develop. Any such symptoms are verified by objective tests.
详细描述
Design: Prospective clinical cohort study.
Patients: 193 sequentially enrolled patients evaluated for suspected symptomatic deep vein thrombosis of the leg, reporting to the LDS Hospital or Intermountain Medical Center Peripheral Vascular Laboratory. Vascular technicians will screen patients for study entry with a simple questionnaire. Those meeting screening criteria will then be interviewed by the study coordinator to verify they meet inclusion criteria, have no exclusions, and provide informed consent.
Demographic and medical history information:
Study clinical variables are obtained from the enroller interview and electronic medical record at entry and included in a computerized clinical database. They include age, sex, weight, inclusion and exclusion criteria, and clinical information necessary to create the pre-test clinical score. Demographic information and basic biometrics (gender, height, weight, leg circumference) will be obtained and recorded by the study coordinator. Informed consent documents will be obtained and stored according to the policies of the Institutional Review Board. All female patients will undergo urine or serum pregnancy testing prior to study entry.
Measurements: A research clinician will perform a brief clinical assessment specific for determining pre-test probability of DVT prior to evaluation with diagnostic tests. This formalized scoring system has been validated in a prior study. Patients with a clinical score of "DVT unlikely" will undergo comprehensive duplex ultrasonography. If normal, patients will be followed for clinical events as described below.
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
- Diagnostic
- 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
- 否
入选标准
- •Be referred for suspected first ipsilateral episode of acute DVT of the lower extremities.
- •Be > 18 y.o.
- •Provide written informed consent
排除标准
- •Pregnant.
- •Compression ultrasonography cannot be performed due to physical or technical reasons.
- •Long-term follow-up will not be possible due to geographic inaccessibility, homelessness or lack of a telephone.
- •Therapeutic doses of an anticoagulant have been received for more than 24 hours before enrollment.
- •Informed consent cannot be obtained.
- •Long term anticoagulation will be required for another diagnosis (e.g. atrial fibrillation).
结局指标
主要结局
Symptomatic VTE
时间窗: Three months
The rate of objectively-confirmed thromboembolic complications (including death attributed to thromboembolic disease) in patients with a score rated as "DVT likely" on a formalized scoring system, when anticoagulation therapy is withheld based on a single, negative comprehensive duplex ultrasound.
次要结局
未报告次要终点