Extended Low-Molecular Weight Heparin VTE Prophylaxis in Thoracic Surgery
Extended Low-Molecular Weight Heparin VTE Prophylaxis in the Thoracic Surgery Population, a Prospective, Randomized Controlled Study
研究概览
详细说明
There is currently very limited information available on the incidence of venous thromboembolism (VTE) in patients undergoing lung cancer resection and the utility of extended thromboprophylaxis (ET) in this patient population. Furthermore, in contrast to patients undergoing orthopaedic surgery where ET has become standard of care, duration of thromboprophylaxis is not well defined in this patient population. Therefore, there is a clear need to systematically evaluate the effects of extended VTE prophylaxis on the incidence of VTE in the post-op population.
As a pilot study, the primary outcome will involve feasibility measures. The investigators aim to measure the proportion of recruitment within each centre, compliance, loss to follow-up, and tolerability of the intervention, defined as the number and severity of per-defined adverse events. The primary outcome of interest for the future full-scale trial is the 30-day incidence rate of VTE following extended 30-day prophylaxis (defined as pulmonary emboli or deep venous thromboembolism of the lower limb as detected by CT (Computed Tomography) pulmonary angiography and full leg Doppler ultrasound, respectively) following lung resection for malignancies.
The proposed pilot project is a multicenter blinded placebo-controlled randomized controlled pilot clinical trial assessing the feasibility and effectiveness of extended-duration VTE prophylaxis (30 days post-operatively) vs. short-term prophylaxis restricted to in-hospital stay with outpatient injected placebo, in patients undergoing lung resection for lung cancer or metastatic disease. All patients will receive both a peri-operative dose followed by postoperative VTE prophylaxis for the duration of their hospital stay. Those who were randomized to prolonged prophylaxis will continue the same dosage regime for an overall of 30 days, whereas the control group will receive placebo injections for the same duration of time.
研究类型
注册 (实际的)
阶段
- 阶段2
- 阶段1
联系人和位置
学习地点
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Ontario
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Hamilton、Ontario、加拿大、L8N 4A6
- St. Joseph's Healthcare Hamilton
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Toronto、Ontario、加拿大、M5G 2C4
- Toronto General Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients must be at least 18 years of age.
- Patient may be of either gender.
- Patients must be diagnosed with resectable lung cancer or metastatic lung disease eligible to complete metastasectomy.
- Patients must be undergoing one of the following surgeries: segmentectomy, wedge resection, lobectomy, bilobectomy or pneumonectomy.
- Patients must be competent to understand consent documents.
Exclusion Criteria:
- All patients with known allergic or anaphylactic reaction to contrast dye, heparin or low molecular weight heparin (LMWH).
- Patients must not be under current anticoagulation for venous thromboembolism or other medical conditions.
- Patients must not have known renal impairment (defined as estimated glomerular filtration rate of less than 30ml/min/m2 as calculated by the Cockcroft-Gault method) either pre-operatively or as identified based on blood work obtained prior to the scheduled 30-day post-operative scan.
- Patients must not have known hepatic failure, with international normalized ratio (INR) of >1.5.
- Patients with history of, or ongoing liver disease, manifested as ascites or previous peritoneal tapping for ascites.
- Patients must not be pregnant or planning to become pregnant.
- Patients must not have been diagnosed or treated for VTE in the past 3 months prior to surgery.
- Patients must not have a known, objectively confirmed bleeding disorder.
- Patients must not have a present or previous increase risk of haemorrhage.
- Patients must not have a history of previous heparin induced thrombocytopenia.
- Baseline platelet count <75,000 but transient, recovered thrombocytopenia associated with chemotherapy will not be a basis for exclusion.
- Patients must not have previously inserted inferior vena cava filter.
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：LMWH: Dalteparin
Consenting patients undergoing lung resection will receive standard postoperative thromboprophylaxis in hospital until the time of discharge.
Subsequently, patients will be administered LMWH for duration of 30 days as outpatients.
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Dalteparin is a low-molecular weight heparin.
The dosage used will be 5000 units once daily (administered as a subcutaneous injection).
This is an established prophylactic dose used to prevent the incidence of VTE after surgery.
其他名称：
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安慰剂比较：Placebo
After undergoing lung resection these patients will research standard post-op TE prophylaxis and upon discharge will be administered a placebo injection of subcutaneous saline for 30 days duration.
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Upon hospital discharge, half of the patients will be assigned to receive saline placebo injections for up to 35 days after surgery.
These injections will have no effect.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Composite primary outcome: To determine the feasibility of a full scale trial by determining the recruitment rates and loss to follow up rates
大体时间：1-1.5 years
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Measuring accrual rates, patient compliance, adherence to protocol, any-cause loss to follow up, tolerability of the intervention (safety), adverse events, and coordination of participating centre infrastructure
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1-1.5 years
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Clinical outcome:Comparison of Incidence of DVT and PE at 30 days after surgery between control and interventional arms (Outcome will be measured by a Chest Computed Tomography (CT) scan with PE contrast protocol and a full leg doppler ultrasound)
大体时间：30 days, +/- 5 days
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As a pilot study, there is an insufficient number of patients to definitively calculate incidence and compare treatment arms.
However, this is a key outcome and the study will seek to determine this outcome.
Outcome will be measured by a Chest Computed Tomography (CT) scan with PE contrast protocol and a full leg doppler ultrasound at approximately 30 days after surgery to seek the occurrence of clots
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30 days, +/- 5 days
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Occurrence of major and minor bleeding at 30 days post-surgery, +/- 5 days
大体时间：30 days after surgery
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Bleeding is a potential adverse event of Fragmin use.
Major bleeding is defined as: Fatal bleeding OR Critical bleeding in a symptomatic area (intracranial, intraspinal, retroperitoneal, pericardial, or intramuscular with compartment syndrome) OR Bleeding causing a fall in hemoglobin level of 2g/dL or more as measured by a blood test at 30 days follow up, OR Bleeding requiring a blood transfusion of at least 2 units of packed red blood cells (excluding transfusions administered intra-operatively or 6-hrs post-operatively since these could not be impacted by post-surgical prophylaxis).
Minor bleeding is defined as any bleeding episode not classified as major.
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30 days after surgery
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Comparison of mortality within 90 days of surgery between control and interventional arms
大体时间：90 days
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Both procedure-specific and all-cause mortality rates will be calculated
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90 days
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Number of cases of heparin administration related HIT (Heparin Induced Thrombocytopenia) within 90 days of surgery
大体时间：90 days
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90 days
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Number of participants with study-related adverse events within 90 days of surgery
大体时间：90 days
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90 days
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Comparison of non-DVT-associated PE events (those occurring without an antecedent DVT) between control and interventional arms
大体时间：90 days
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90 days
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合作者和调查者
调查人员
- 首席研究员：Yaron Shargall, MD, FRCSC, FCCP、McMaster University
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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