Effects of OctaplasLG® on Endothelial Integrity in Patients Undergoing Emergency Surgery for Thoracic Aortic Dissections - a Randomized, Controlled, Single-blinded Investigator-initiated Pilot Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Plasma levels of endothelial markers (Syndecan-1, sTM, sE-selectin, sVE-cadherin)
研究概览
简要总结
Effects of OctaplasLG® on endothelial integrity in patients undergoing emergency surgery for thoracic aortic dissections - a randomized, controlled, single-blinded investigator-initiated pilot trial
详细描述
Trial Name: VIPER-OCTA trial - Vasculopathic Injury and Plasma as Endothelial Rescue - OCTAplas trial
Background
- Patients operated for thoracic aortic dissections in deep hypothermic circulatory arrest are prone to develop postoperative renal failure secondary to severe endothelial dysfunction and capillary leakage, and currently no therapy addressing this complication has proven successful
- Data from animal models of shock and massively bleeding patients indicate that plasma may be beneficial for re-establishing endothelial integrity
- Patients operated for thoracic aortic dissections generally develop requirement for massive transfusion during surgery
- Current guidelines, however, recommend against plasma transfusion to patients not needing coagulation factor replacement due to the inherent risk of transfusion complications
- OctaplasLG® is an immune complex-free and cell-free, pathogen inactivated standardized plasma product that has been shown not to be related to the transfusion complications seen secondary to standard fresh frozen plasma (FFP), thus, OctaplasLG® may be a beneficial, alternative resuscitation fluid in patients with severe endothelial dysfunction/damage
- The purpose is to bridge the knowledge gap regarding the effect of OctaplasLG® on endothelial integrity and safety
Design Single-centre randomised, single-blinded, controlled, investigator-initiated pilot trial of 42 patients undergoing emergency surgery for thoracic aortic dissections randomized to administration of OctaplasLG®, as compared to standard FFP, as coagulation factor replacement related to bleeding, when need for coagulation factor replacement is deemed necessary by the clinician according to local protocol.
Inclusion criteria
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Patient eligible for emergency surgery on cardiopulmonary bypass pump for a thoracic aortic dissections AND
- •Age > 18 years AND
- •Consent obtainable from patient or by proxy (independent physicians and/or next of kin)
排除标准
- •Documented refusal of blood transfusion OR
- •FFP transfusion before randomization OR
- •Aortic dissection due to trauma OR
- •Treatment with GPIIb/IIIa inhibitors < 24h from screening OR
- •Withdrawal from active therapy OR
- •Expected to die < 24h OR
- •Previously within 30 days included in a randomized trial, if known at the time of enrolment
- •Known IgA deficiency with documented antibodies against IgA
- •Known hypersensitivity to OctaplasLG®: the active substance, any of the excipients (Sodium citrate dihydrate, Sodium dihydrogenphosphate dihydrate or Glycine) or residues from the manufacturing process (Tri (N-Butyl) Phosphate (TNBP) and Octoxynol (Triton X-100))
- •Known severe deficiencies of protein S
- •Pregnancy (non-pregnancy confirmed by patient being postmenopausal or having a negative serum-hCG)
研究组 & 干预措施
OctaplasLG®
replacement to bleeding
干预措施: OctaplasLG® (Drug)
Standard fresh frozen plasma
replacement to bleeding
干预措施: Fresh frozen plasma (Biological)
结局指标
主要结局
Plasma levels of endothelial markers (Syndecan-1, sTM, sE-selectin, sVE-cadherin)
时间窗: At 24 hours after arrival in ICU for postoperative care, as compared to baseline
次要结局
- Plasma levels of endothelial markers (Syndecan-1, soluble thrombomodulin (sTM), sE-selectin, sVE-cadherin)(At 48 hours postoperatively, as compared to baseline)
- Length of stay in ICU and hospital(Days, assessed at 30-days and 90-days)
- Mortality(30-day and 90-day)
- Acute Kidney Injury (AKI) according to RIFLE Criteria(In the first 7 postoperative days)
- Renal replacement therapy(In the first 7 postoperative days)
- Severe adverse reactions(In the first 30 postoperative days)
- Sepsis-Related Organ Failure Assessment (SOFA)(Worst score In the first 7 postoperative days)
- P-Creactive protein (CRP), Interleukin-6 (IL-6), P-Catecholamines(At 24 hours and 48 hours)
研究者
Jakob Stensballe, MD, PhD
MD, PhD, Consultant
Rigshospitalet, Denmark