A Blinded, Controlled, Randomized Study of the Safety of Pre-operative Enoxaparin in the Surgical Management of Multi-trauma Patients Undergoing Orthopedic Surgical Procedures
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Evaluate Bleeding Complications Related to DVT chemoprophylaxis
研究概览
简要总结
All trauma patients receive Lovenox or other prophylactic medication to prevent deep vein clots from forming. For the trauma patients with orthopedic injuries requiring surgery there is controversy over safety and efficacy when prophylaxis is started preoperatively vs postoperatively. This study is to evaluate both approaches for safety in terms of bleeding events during and 24 hours after surgery as well as preventing deep vein clot formation. This will be a randomized double blinded study using Lovenox or placebo as the medications given preoperatively. Postoperative Lovenox will be given to both groups per routine regime.
详细描述
This study will be conducted in an Intensive Care Unit (ICU) and Operating Room (OR) of Valleywise Health Medical Center. The study population will include adult subjects age ≥ 18 years of age, that require surgery for management of their traumatic long bone and/or pelvic fractures.
A total of 60 evaluable subjects will be enrolled in this pilot safety study, with a 1:1 randomization into each group. It is anticipated that approximately 70 patients will need to be consented to reach 60 evaluable subjects.
Subjects recruited for study participation must meet all study enrollment criteria prior to being enrolled in the study. Patients who meet inclusion / exclusion criteria will be invited to participate in the study. As feasible, the patient or his/her representative will be approached for enrollment in the study and asked to provide informed consent for participation.
Written informed consent will be obtained for all subjects by an investigator or delegate prior to enrollment in the study. All subjects meeting inclusion/exclusion criteria will be randomized to either enoxaparin or placebo.
Patients will be monitored for bleeding complications from the time of test article administration to 24 hours post-surgery. Subjects will be monitored for the development of DVT and/or PE through-out their hospitalization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Blinding will be done by research pharmacist. Nurse Manager will also be un-blinded.
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
- •Age > 18 years
- •Traumatic injury of long bones or pelvis requiring surgical intervention
- •Admission to the ICU
排除标准
- •Age < 18 years
- •Intracranial hemorrhage
- •Direct admit to OR without prior ICU admission
- •Pregnancy
- •Chronic Kidney Disease requiring dialysis or a glomerular filtration rate (GFR) or creatinine clearance requiring a decrease in Enoxaparin dosage
- •Presence of DVT prior to study drug dose
研究组 & 干预措施
Enoxaparin
Enoxaparin dose will not be held for surgical procedure.
干预措施: Enoxaparin Injectable Product (Drug)
Placebo dose given and Enoxaparin dose held
Enoxaparin dose will be held and replaced by placebo and not given prior to surgical procedure.
干预措施: Sodium chloride (Drug)
结局指标
主要结局
Evaluate Bleeding Complications Related to DVT chemoprophylaxis
时间窗: From the time of study drug administration to 24 hours post-operation
Evaluate the rate of bleeding complications related to DVT chemoprophylaxis after administering DVT chemoprophylaxis vs holding doses within 12 hours of surgery in patients with long bones and/or pelvic fractures requiring surgical intervention.
Evaluate Other Complications (besides bleeding) Related to DVT chemoprophylaxis
时间窗: From the time of study drug administration to 24 hours post-operation
Evaluate the rate of other complications (besides bleeding) Related to DVT chemoprophylaxis after administering DVT chemoprophylaxis vs holding doses within 12 hours of surgery in patients with long bones and/or pelvic fractures requiring surgical intervention.
次要结局
- study duration(From Institutional Review Board approval to date of last subject completion up to 2 years)
- Incidence of DVT and PE(From the time of study drug administration to hospital discharge up to 3 months)
- Assess feasibility of a larger trial with respect to study design(Duration of the study up to 2 years)