Prophylaxis Against Thromboembolic Disease Following Orthopaedic Surgeries on Extremities
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Primary Outcome based upon intent to treat: Composite outcome of
研究概览
简要总结
The purpose of this research is to find a better way to prevent the post operative development of clots in the deep veins of the legs (also called Deep Vein Thrombosis or DVT). DVT causes redness, swelling, and pain in the involved leg(s). Long-term complications may include permanent swelling and pain of the leg(s), and even skin ulcers around the ankle. If clots form in a leg after surgery, and break off, they can move to the lungs and block the pulmonary artery (also called Pulmonary Emboli or PE). With PE there can be chest pain, chest tightness, shortness of breath, coughing up blood, heart failure, and occasionally death.
Doctors have studied ways to reduce these complications. These studies led to the development of drugs which interfere with your body's clotting processes. However, it is still unclear which drug and which drug schedule is best. This study will evaluate two of the standard FDA approved drugs using different dosing schedules.
详细描述
Inclusion Criteria:
- Planned for elective primary arthroplasty for knee and hip disease at New England Baptist Hospital.
- Over 20 years of age.
- Normal baseline platelet count, prothrombin and partial thromboplastin times.
- Signed consent.
Exclusion Criteria:
- Surgery for acute fracture (< 4 weeks), septic joint, or extraction arthroplasty.
- Patients with personal history of TED, or documented hypercoagulation disease.
- Increased risk of hemorrhage, as from active gastric ulcer, or bleeding diathesis; or persistent intestinal or urinary tract bleed within the last year.
SPECIFIC AIMS:
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Planned for elective arthroplasty for knee and hip disease.
- •Over 20 years of age.
- •Normal baseline platelet count, prothrombin and partial thromboplastin times.
- •Signed consent.
排除标准
- •Surgery for acute fracture (< 4 weeks), septic joint, or extraction arthroplasty.
- •Patients with personal history of TED, or documented hypercoagulation disease.
- •Increased risk of hemorrhage, as from active gastric ulcer, or bleeding diathesis; or persistent intestinal or urinary tract bleed within the last year.
- •Hemorrhagic stroke; brain, spinal, or ophthalmologic surgery in previous 6 months.
- •Liver enzymes or bilirubin greater than 2 x normal.
- •Decreased renal function with GFR < 30ml/min. (24-27)
- •Cancer in last 1 year, other than localized cancers of the skin.
- •Requires chronic anticoagulation with warfarin or heparins.
- •Requires chronic platelet function suppressive therapy for coronary or peripheral artery stents..
- •Prior adverse reaction to any of the study drugs.
- •Uncontrolled hypertension
研究组 & 干预措施
1
Variable dose warfarin: 5 mg beginning the night before surgery, followed by 5mg the PM of surgery*, and then variable daily dose,until day 30 follow-up.
(target INR 2.0-2.5)
干预措施: warfarin (Drug)
3
Fixed Low Dose warfarin
1 mg daily beginning 7 days preoperative, and continued at 1 mg daily follow-up at Day 28 (+/-2 days from surgery).
干预措施: warfarin (Drug)
结局指标
主要结局
Primary Outcome based upon intent to treat: Composite outcome of
时间窗: 28 days
Ultrasound or venogram confirmed deep vein thrombosis.
时间窗: 28 days
Lung scan, pulmonary angiogram or CTA confirmed pulmonary embolus.
时间窗: 28 days
Death due to TED
时间窗: 28 days
次要结局
- Patient compliance with preoperative and post-operative medication schedule. Not enough space to note all measures(28 days)
- Distribution of proximal vs distal deep vein thrombosis of the leg(28 days)
- Amount of intraoperative bleeding(follow until Dec. 31, 2010)
- Amount of postoperative bleeding A. transfusion requirement B. Hematomas requiring intervention, or other bleed clinically thought to be related to study drug. C. Other hemorrhagic events.(follow until Dec. 31, 2010)
- Number of ultrasounds and V/Q or CTA's required(follow until Dec. 31, 2010)
- Costs associated with each study arm, including that of drug, laboratory monitors, radiology procedures required, lengths of stay, and management of complications(follow until Dec. 31, 2010)
- Determine if negative D-D dimer can eliminate need for ultrasound analysis at follow-up visit.(follow until Dec. 31, 2010)
- Death due to any other cause than TED(follow until Dec. 31, 2010)
- Use of low molecular weight dextran(follow until Dec. 31, 2010)
- Use of nonsteroidal anti-inflammatory drugs(follow until Dec. 31, 2010)