Study ESPER: Blood-sparing During the Placement of a Total Hip Prosthesis With the Exacyl® in Patients Treated With Rivaroxaban, Phase IV
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 231
- 试验地点
- 4
- 主要终点
- Total blood loss
研究概览
简要总结
This study evaluates the efficacy of tranexamic acid versus placebo on perioperative blood loss using two dosage regimens (standard and extended) after a surgery during total hip arthroplasty in patients receiving the novel fast-acting oral anticoagulant rivaroxaban for prophylaxis of thrombosis.
详细描述
In 2011, 140 000 total hip replacements were performed and bleeding remains one of the major complications responsible for significant morbidity. This study will evaluate a new treatment to prevent bleeding due to this surgery. Indeed, the tranexamic acid (Exacyl) will be used in two modes of administration (standard or extended) versus placebo combined with a Rivaroxaban treatment at a dose of 10 mg / day for 35 days.
Patients will be randomized (exacyl standard vs exacyl extended vs. placebo) and will be followed for 3 months.
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
- Double (Participant, Investigator)
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
- •Over 18 years of age
- •Scheduled to undergo elective non-traumatic primary cementless THA
- •Having given written informed consent to participate in the trial
- •Covered by Social Security
排除标准
- •Rapidly destructive arthrosis of the hip
- •History of prior surgery on the operative hip
- •Contraindications to the use of tranexamic acid:
- •Ischaemic artery disease (angina pectoris, myocardial infarction, acute coronary syndrome or stroke)
- •History of venous thromboembolism
- •Severe renal impairment, i.e. with clearance < 30mL/mn
- •Epilepsy or history of convulsions
- •Contraindications to the use of rivaroxaban
- •Severe renal failure (clearance <30ml / min)
- •Cirrhotic patients with Child Pugh B
- •Pregnancy and breastfeeding
- •Cognitive disorder that precludes giving informed consent
- •Refusal to participate in trial
- •Allergy to either of the trial treatments
- •On-going prophylaxis of thrombosis using an agent other than rivaroxaban
- •On-going platelet aggregation inhibitor at a dose exceeding 125 mg daily
研究组 & 干预措施
Group 1: Exacyl®: Standard treatment
Intravenous use. 1g Exacyl® at H0 (Hour = 0 in other term at the time of incision) then 1g Exacyl® at H+3 then 1g Exacyl® placebo at H+7 and H+11
干预措施: Exacyl® (Drug)
Group 1: Exacyl®: Standard treatment
Intravenous use. 1g Exacyl® at H0 (Hour = 0 in other term at the time of incision) then 1g Exacyl® at H+3 then 1g Exacyl® placebo at H+7 and H+11
干预措施: Placebo of Exacyl® (Other)
Group 2: Exacyl®: Extended treatment
Intravenous use. 1g Exacyl® at H0 (Hour = 0 in other term at the time of incision) then 1g Exacyl® at H+3 / H+7 and H+11
干预措施: Exacyl® (Drug)
Group 3: Placebo
This group will receive a placebo of Exacyl®: 1g placebo of Exacyl® at H0 (Hour = 0 in other term at the time of incision) then 1g placebo of Exacyl® at H+3 / H+7 and H+11
干预措施: Placebo of Exacyl® (Other)
结局指标
主要结局
Total blood loss
时间窗: Between Day-1of surgery and Day+3 of surgery (5 days)
Total Blood Loss (TBL) in mL of red blood cells, calculated using Mercuriali's formula at 100% haematocrit (Ht) and then converted to mL of blood at 35% Ht
次要结局
- Difference in haemoglobin level (g/dL) between Day-1 and Day+3(5 days)
- Maximum difference in haemoglobin level (g/dL) from D-1 up to D+3(5 days)
- Number of transfusions and volume in mL performed during hospitalisation (operating theatre and unit)(5 days)
- Major haemorrhagic events, clinically significant non-major haemorrhagic events and minor haemorrhagic events(3 month)
- Surgical revision(3 month)
- Occurrence of venous or arterial thromboembolic events(3 month)
- Local infectious complications(3 month)
- Death due to any cause and death due to cardiovascular cause(3 month)