Dalteparin's Influence on Renally Compromised: Anti-Ten-A Study (DIRECT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 14
研究概览
简要总结
The investigators' primary research objective is:
-
To determine the safety of dalteparin prophylaxis, 5,000 IU once-daily, in Intensive Care Unit (ICU) patients based on:
-
the proportion of patients with trough anti-Xa > 0.40 IU/mL during dalteparin prophylaxis after 3 + 1 days, 10 + 1 days, and 17 + 1 days of dalteparin prophylaxis;
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the risk of major bleeding during the treatment period.
The investigators' secondary research objectives are:
- To determine the pharmacokinetic properties of dalteparin prophylaxis in ICU patients with severe renal insufficiency;
- To identify clinical and laboratory factors that predict an excessive anticoagulant effect (anti-Xa > 0.10 IU/mL);
- To estimate the relationship between trough anti-Xa levels and bleeding.
The DIRECT Pilot Study:
Before embarking on a large trial of low molecular weight heparin (LMWH) versus standard unfractionated heparin (UFH), the DIRECT Study is needed to observe whether bioaccumulation of LMWH occurs in ICU patients with moderate to severe renal insufficiency, and to address potential problems with protocol implementation.
详细描述
Critically ill patients who are admitted to an intensive care unit (ICU) are at high risk for deep vein thrombosis (DVT), with an estimated 20-40% of patients developing DVT without prophylaxis. Preventing DVT is important because DVT is usually clinically silent in such patients, and its first manifestation may be life-threatening pulmonary embolism.
About 30% of ICU patients have renal insufficiency, based on a calculated creatinine clearance (CrCl), and such patients have 4-fold higher risk of DVT than those with normal renal function.
The current anticoagulant regimen that is used to prevent DVT in such patients, consisting of unfractionated heparin (UFH), 5000 IU twice-daily, may be inadequate.
A recent prospective cohort study by our research group that investigated the risk of DVT in 261 ICU patients found that 10% of patients developed proximal vein DVT after admission to the ICU despite receiving UFH, 5000 IU twice-daily.
In other patient groups at high risk for DVT, low-molecular-weight heparins (LMWHs) have replaced UFH for DVT prophylaxis because of superior efficacy.
研究设计
- 研究类型
- Observational
- 观察模型
- Defined Population
- 时间视角
- Prospective
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
- •Adult patient aged > 18 years
- •Admitted to an ICU with an expected ICU length of stay > 72 hours
- •Severe renal insufficiency, defined by a calculated CrCl < 30 mL/min/1.73m2
排除标准
- •ICU admission for > 2 weeks at time of screening
- •ICU admission within 3 months of cardiac surgery or neurosurgery
- •Active bleeding or at high risk for bleeding complications
- •Thrombocytopenia (platelet count < 75 x 10^9/L) at time of screening
- •Coagulopathy (International Normalized Ratio [INR] or activated partial thromboplastin time [aPTT] > 2 times upper limit of normal) at time of screening
- •Patient had an indwelling epidural catheter for epidural analgesia within the last 12 hours
- •Receipt of > 2 doses of LMWH (prophylactic- or therapeutic-dose) in the ICU
- •Receiving or requiring therapeutic-dose anticoagulation (eg., deep vein thrombosis [DVT]) at time of screening
- •Receiving dialysis that requires anticoagulation (eg., PRISMA, slow continuous ultrafiltration [SCUF]) at time of screening
- •Weight < 45 kg
- •Woman who is pregnant or lactating
- •Bilateral lower limb amputation
- •Previous adverse reaction to heparin or LMWH (eg., allergy, heparin-induced thrombocytopenia [HIT])
- •Contraindication to receiving blood products
- •Life expectancy < 14 days or receiving palliative care
- •Prior enrolment in this study or enrolment in a concurrent related clinical trial
- •Patient or surrogate decision-maker does not provide consent to participate in study