Benefit of Prophylactic Embolization of the Splenic Salvage in Trauma Patients at High Risk of Splenectomy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 2
- 主要终点
- Rescue rate
研究概览
简要总结
The main objective is to show that splenic embolization improves salvage rate at one month in a population of hemostatically stable closed splenic trauma patients with a high risk of splenectomy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged over 18 and under 75 years
- •hemodynamically stable patients (systolic BP ≥ 90 mm Hg and no hemorrhagic shock)
- •Suffered a closed splenic trauma within the last 48 hours
- •A high risk of splenectomy:
- •Reaching spleen Moore grade 4 and 5 in the abdominal injected CT or
- •Reaching spleen Moore 3 and at least one of the following characteristics:
- •Important Hemoperitoneum (when visible in the pelvic area).
- •Severe associated impairment (NISS-New Injury Severity Score greater than or equal to 15)
- •Patients volunteering to participate in the study, having signed the consent form or with the agreement of the family if the patient is not capable of giving consent; after adequate information and delivery of the patient and/or family information leaflet.
- •covered by a social security scheme or beneficiary of such a plan.
排除标准
- •Patients whose usual residence is outside the European Economic Community
- •Patient with hemodynamic instability (systolic blood pressure <9 despite resuscitation maneuver)
- •Patient with open splenic trauma
- •Patient with surgical indication excluding the possibility of monitoring splenic trauma
- •Patient with an indication for embolization of a body other than the spleen at the time of inclusion
- •Patient with an indication for splenic embolization as a result of a post-traumatic vascular anomaly (active leakage of contrast agent, pseudoaneurysm or early splenic arteriovenous fistula).
- •Patients aged less than 18 years and ≥ 75 years
- •Patients with a previous spleen disease (tumor, infection, vascular anomaly intrasplenically)
- •Patient with trauma Moore grade 1 or 2
- •Patient with trauma grade Moore 5 with total ischemia of the spleen
- •Patients who underwent partial or total splenectomy before inclusion
- •Patient having acquired or innate immune deficiency
- •All indications not permitting the achievement of embolization
- •Pregnant woman
- •Person deprived of liberty by judicial or administrative decision, person subject to a measure of legal protection.
- •Patient currently participating in a clinical study or having participated in a clinical study in the month preceding the inclusion
- •Patient with a condition or a history of mental or psychiatric disorder or any other factor limiting their ability to participate in an informed manner and to comply with the protocol.
研究组 & 干预措施
Embolization
this arm of the study was interventional (embolization) with CT scans at inclusion (D0, to validate the inclusion criteria), at one month (D30-validating the primary endpoint) and at 6 months (D180) read by 2 expert radiologists blinded to the study arm
干预措施: Embolization (Procedure)
Surveillance
this arm of the study was non-interventional (surveillance), with CT scans at inclusion (D0, to validate the inclusion criteria), at one month (D30-validating the primary endpoint) and at 6 months (D180 ) read by 2 expert radiologists blinded to the study arm
结局指标
主要结局
Rescue rate
时间窗: Splenic Rescue at 30 days
The main objective is to show that splenic embolization improves salvage rate at one month in a population of hemostatically stable closed splenic trauma patients with a high risk of a splenectomy. The primary endpoint is an immunocompetent spleen i.e. intact or treated by surgical methods for splenic preservation of at least 50% of splenic vascularized tissue in the event of secondary laparotomy or with necrosis of less than 50% by volume. This criterion will be validated by a review of the initial scans by a panel of two senior radiologists blinded to the study arm.
次要结局
- Mortality(At 1 and 6 months)
- Morbidity(at 1 and 6 months)