Assessment of Blood Loss With a Point Of Care Device (BLOOD)
Assessment of Blood Loss With a Point Of Care Device During Hip/Knee Surgery Performed On Dual/Single Antiplatelet Therapy
研究概览
地位
详细说明
Type of study : Prospective, non-interventional, multicenter registry Principal Investigator: Collet Jean-Philippe Rational: Discontinuation of antiplatelet therapy in patients with established coronary artery disease (CAD) has become an increasingly important concern given the risk of recurrent arterial event. Exaggerated concern about increased procedure-related bleeding remains the major factor for premature discontinuation of APT. Interruption modalities and their impact on perioperative bleeding has never been prospectively evaluated and it is accepted that the maximum duration of interruption should not exceed 5 days for Clopidogrel/Ticagrelor and 7 days for Prasugrel given the fact that the remaining antiplatelet effect of APT is observed in less than 50% of patients after 3 days of interruption. Resuming APT after the operation has never been studied and remains a complex situation during anticoagulation is often prescribed to prevent deep vein thrombosis further increasing perioperative bleeding.
Hypotheses: (i) the volume of perioperative blood loss is correlated to the degree of platelet inhibition. (ii) Clopidogrel metabolizer status as defined by genetic profile is also correlated to perioperative blood loss. (iii) Resuming antiplatelet therapy during the perioperative period is not associated with a significant recovery of the antiplatelet effect.
Primary endpoint: Perioperative (day 1-day 5) blood loss in mL assessed by NADLER & Mercurial formula* and PRU** (for patients under Clopidogrel/ARU*** as measured using the VerifyNow®P2Y12 and aspirin assays at baseline. Secondary objectives: (i) to evaluate the correlation between clopidogrel genetic metabolizer status**** and perioperative blood loss. To evaluate antiplatelet pharmacodynamic response at discharge according to metabolizer status. Definition*Blood loss in mL of Red Blood Cell (RBC) = Compensated RBC Volume (1 Pack=150mL) + Non Compensated RBC Vol. (Total Blood Loss : Ht D-1-Ht D+5). *PRU=Platelet Reaction Unit. It is a specific measure of on-clopidogrel platelet reactivity. Cut-off value is for defining high-on clopidogrel platelet reactivity is 230. **ARU=Aspirin Reaction Unit. It is a specific measure of on-aspirin platelet reactivity. Cutoff value to identify high on-aspirin platelet reactivity is 550. ***Clopidogrel Metabolizer Phenotype is defined according to the carriage of the loss/gain-of function allele 2C19*2-*8/*17 as follows: SM for slow metabolizer: (*2-*8/*2-*8) ; Ultrafast Metabolizer (FM): (*17/*17) ; Normal/intermediate (M): (wt/wt, wt/*17, *2-*8/*17 or *2-*8/wt)
Number of subjects : 200 patients
Study duration: Two years.
Study duration per subject: length of hospital stay with a maximum duration of 30 days.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Paris、法国、75013
- Institute of cardiology - Pitié Salpêtrière Hospital
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Paris、法国、75013
- pôle Anesthesie -Réanimation- CHU Pitie -Salpetrière
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Toulouse、法国、31403
- CHU Toulouse - Hôpital de Rangueil - Anésthésie-Réanimation
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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
取样方法
研究人群
This study targets CAD patients exposed to antiplatelelt mono/bitherapy who need planned or emergency knee/hip athroplasty. This innovative study will bring new insights on how works antiplatelet therapy during the perioperative period according to drug exposition and metabolizer profile.
Patients ethnicity will be recorded and defined according to the place of birth of the participants and of their parents given the identification of the metabolizer profile with respect to the CYP 2C19*2 carriage. The analysis will bestratified according to ethnicity to avoid biases.
描述
Inclusion Criteria:
- ≥18 years
Patient in antiplatelet monotherapy (aspirin or clopidogrel) or dual therapy (aspirin + clopidogrel / prasugrel / ticagrelor) in the context of secondary prevention after:
- acute coronary syndrome
- and / or intracoronary stenting
- Planned or urgent hip (gamma nail, total prosthesis or through DHS) or knee arthroplasty
- Informed consent of the participant
- Patient receiving a social security scheme or entitled
Exclusion Criteria:
- Polytrauma
- Anemia <9g/dL
- Indication for oral anticoagulation
- Pelvic fracture justifying complex surgery
- Ongoing or recent major bleeding or recent major surgery (< 3 weeks)
- Liver failure
- Thrombopenia <80 000/µl
- Lack of health insurance
- Mental disability
- Participation to any other research protocol
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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Planned hip or knee arthroplasty
Patients with planned hip or knee arthroplasty
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urgent hip or knee arthroplasty
Patients with hip or knee arthroplasty in emergency.
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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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Perioperative blood loss in mL assessed by NADLER & Mercurial formula* and PRU**/ARU*** as measured using the VerifyNow®P2Y12 and aspirin assays at baseline
大体时间:day 1- day 5
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Perioperative (day 1-day 5) blood loss in mL assessed by NADLER & Mercuriali formula* and PRU**/ARU*** as measured using the VerifyNow®P2Y12 and aspirin assays at baseline.
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day 1- day 5
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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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Evaluate the correlation between clopidogrel genetic metabolizer status**** and perioperative blood loss.
大体时间:up to 10 days
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When the patient discharges of surgery department
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up to 10 days
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To evaluate clopidogrel and aspirin pharmacodynamic response at discharge according to metabolizer status.
大体时间:up to 10 days
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When the patient discharges of surgery department
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up to 10 days
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合作者和调查者
调查人员
- 首席研究员:COLLET Jean-Philippe, MD-PhD、Assistance Publique - Hôpitaux de Paris
研究记录日期
研究主要日期
学习开始 (实际的)
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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