Use of Whole-leg Ultrasound for Diagnosis of Deep Vein Thrombosis in Pregnant Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 268
- 试验地点
- 2
- 主要终点
- Symptomatic VTE
研究概览
简要总结
This study seeks to determine the rate of thromboembolic complications (blood clots), including death attributed to thromboembolic disease, when anticoagulation (blood thinner) therapy is withheld from pregnant patients suspected of deep vein thrombosis (DVT) after a whole-leg compression ultrasound shows no DVT. Patients are followed for three months after the ultrasound to determine if a blood clot is diagnosed during that time.
详细描述
SPECIFIC AIM To determine the rate of thromboembolic complications (including death attributed to thromboembolic disease) in pregnant patients suspected of deep vein thrombosis (DVT) when anticoagulation therapy is withheld on the basis of a negative whole-leg compression ultrasound examination (whole-leg CUS).
BACKGROUND AND SIGNIFICANCE
The diagnosis of deep vein thrombosis of the leg is challenging due to the great variability of clinical presentation and the lack of sensitivity of noninvasive tests. This is particularly true for pregnant patients, who have been excluded from most major studies of diagnostic strategies for DVT. Ironically, pregnancy is considered a major risk factor for DVT, making evidence-based diagnosis in this patient group particularly important.
A study performed at LDS Hospital, found that a single, whole-leg compression ultrasound could safely exclude the diagnosis of suspected, symptomatic, first-episode deep vein thrombosis of the leg. A subsequent metanalysis of studies of the same technique confirmed this finding, but observed that the utility of this strategy in pregnant patients required further study, as only 57 of the over 4,500 subjects in the pooled metanalysis were pregnant.
Therefore, better information regarding the performance of diagnostic testing for suspected DVT in pregnant patients is needed. If whole-leg compression ultrasound proves adequately sensitive in this patient group, this will be a significant step in simplifying the diagnostic process for deep vein thrombosis, and will confirm the diagnostic strategy most commonly used presently by physicians at Intermountain Medical Center.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- Female
- 接受健康志愿者
- 否
入选标准
- •Be suspected by the referring medical provider to have a first episode of acute DVT of the lower extremities.
- •Be presenting for the initial diagnostic ultrasound for the present symptom complex.
- •Pregnancy confirmed by an objective test.
- •Be > 18 years old.
- •Provide written informed consent.
排除标准
- •Compression ultrasonography cannot be performed due to physical or technical reasons.
- •The patient has a prior history of DVT in the ipsilateral leg.
- •Previous venous ultrasound has been performed during the same pregnancy.
- •The patient is suspected by the referring clinician to have symptomatic pulmonary embolism.
- •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.
- •Long term anticoagulation will be required for another diagnosis (e.g. atrial fibrillation).
- •Informed consent cannot be obtained.
研究组 & 干预措施
Ultrasound for suspected DVT
Enrolled subjects suspected to have deep vein thrombosis undergo whole-leg compression ultrasound. Those with a normal result undergo clinical follow-up for thrombotic outcomes over the following three months.
干预措施: Whole-leg compression ultrasound (Other)
结局指标
主要结局
Symptomatic VTE
时间窗: Three months
The primary outcome measure will be DVT or PE, or death attributable to thromboembolic disease confirmed by objective testing in the 3 months following enrollment.
次要结局
- Isolated iliac DVT(At enrollment)
研究者
Scott M. Stevens
Transitional Year Program Director
Intermountain Health Care, Inc.