A Multi-centre, Prospective, Randomized Controlled Study to Compare Outcomes of Non-operative Management (NOM) With and Without Splenic Arterial Embolization (SAE) in Hemodynamically Stable OIS Grade 4 and 5 Splenic Injuries.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 224
- 试验地点
- 12
- 主要终点
- Failure of NOM
研究概览
简要总结
The primary objective is to compare the failure rate due to splenic bleeding between the patients undergoing pre-emptive splenic arterial embolization (SAE) as part of non-operative management (NOM) and the patients not undergoing SAE. We hypothesize that the use of pre-emptive SAE will decrease the delayed bleeding rate and increase the success rate of NOM.
详细描述
This randomised controlled study will follow the clinical course of hemodynamically normal trauma patients with Organ Injury Scale (OIS) grade 4 or 5 blunt splenic injuries, undergoing SAE or observation only until day 7 post injury. Only hemodynamically normal patients will be considered for enrolment into the study, and written informed consent from the patient is required.
CONTROL The control arm in this randomized controlled trial will include only NOM patients diagnosed with splenic injuries OIS grade 4 or 5 and suitable for observation alone, and will comprise clinical observation according to local routines and protocols. The patients will be observed with special focus on delayed bleeding and failure of NOM. A contrast enhanced US or CT scan with arterial phase will be performed on day 3-5 to exclude PSA. On day 7, the decision to perform SAE, splenectomy or continue NOM is left to the discretion of each participating institution, and registered in the case report form (CRF).
INTERVENTION The intervention arm will perform SAE as a central embolization of the splenic artery.
Additional peripheral embolization is left to the discretion of the interventional radiologist.
Each institution decides whether patients in the SAE group are to undergo immunization or not. The study does not interfere with local diagnostic work-up and treatment protocols.
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
- None
入排标准
- 年龄范围
- 16 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •blunt splenic injury OIS grade 4 or 5
- •Adult trauma patients (according to local definitions)
- •Present hemodynamically normal as judged by the responsible trauma consultant surgeon and eligible for NOM
- •Randomised within 48 hours of injury
- •Written informed consent is obtained
排除标准
- •Hemodynamically compromised (not suitable for NOM)
- •Needing transfusions
- •CT shows evidence of significant contrast extravasation
- •Other indications for laparotomy
- •Prisoners
- •>80 years old
- •Penetrating injury
- •Contraindication to iv contrast
研究组 & 干预措施
Embolization
The intervention arm will perform SAE as a central embolization of the splenic artery.
Additional peripheral embolization is left to the discretion of the interventional radiologist.
The study does not interfere with local diagnostic work-up and treatment protocols.
干预措施: Embolization (Procedure)
Observation
The control arm in this randomized controlled trial will include only NOM patients diagnosed with splenic injuries OIS grade 4 or 5 and suitable for observation alone, and will comprise clinical observation according to local routines and protocols.
结局指标
主要结局
Failure of NOM
时间窗: 7 days
The primary objective is to compare the failure rate due to splenic bleeding between the patients undergoing pre-emptive SAE as part of NOM and the patients not undergoing SAE. The primary endpoint is the proportion of subjects failing NOM due to spleen related bleeding within 7 days of injury. All analyses will be based on an intention to treat analysis.
次要结局
- Other spleen related complications(6-12 weeks)
- Angiography related complications(6-12 weeks)
- All cause and spleen related failure of NOM(6-12 weeks)
- Delayed bleeding episode(6-12 weeks)
- Symptomatic thromboembolic events(6-12 weeks)
- Pseudoaneurysms (PSA)(6-12 weeks)
- All cause and spleen related mortality(6-12 weeks)
研究者
Christine Gaarder
Head, Department of Traumatology
Oslo University Hospital