PROSPECTIVE STUDY ON PREOPERATIVE VERSUS POSTOPERATIVE VENOUS THROMBOPROPHYLAXIS IN PATIENTS UNDERGOING MAJOR COLORECTAL SURGERY
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 410
- 试验地点
- 1
- 主要终点
- Number of Participants With Postoperative VTE Within 48 Hours After Surgery
研究概览
简要总结
Patients undergoing major colorectal surgery are at increased risk for VTE (deep venous thrombosis) compared with patients undergoing other general surgical procedures (Bergqvist et al. Dis. Col. Rectum. 2006; 49: 1620-1628.)
The reported incidence of symptomatic VTE after colorectal surgery is approximately 4% (Monn, F. et al. JACS. 216; 2013: 395-401). However, the reported incidence of VTE after colorectal surgery in prospectively followed patients managed with perioperative venous thromboprophylaxis undergoing screening venography prior to hospital discharge ranges from 9 to 20% (Bergovist et al. NEJM 346; 2002: 975-980; McLeod et al. Ann. Surg. 233; 2000: 438-444; ENOXACAN Study group. Brit. J. Surg. 84; 1997: 1099-1103.
The Surgical Care Improvement Project (SCIP) and the American College of Chest Physician (ACCP) guidelines recommend that venous thromboprophylaxis be initiated within 24 hours of surgery. However, it is believed that deep venous thrombosis occurs during surgery, rather than in the postoperative period, justifying preoperative initiation of venous thromboprophylaxis. This practice is accompanied with a theoretically higher risk of bleeding complications.
Currently there is no consensus on the precise timing of VTE prophylaxis after major colorectal surgery, as demonstrated by the vague guidelines established by the ACCP and SCIP. Current studies on VTE prophylaxis report preoperative initiation of VTE prophylaxis. However, majority of surgeons at our institution begin heparin postoperatively given concern for bleeding complications with preoperative dosing of heparin.
The purpose of this study is to prospectively evaluate the incidence of VTE and major bleeding complications in patients undergoing major colorectal surgery who are treated with preoperative or postoperative venous thromboprophylaxis and to help establish more stringent guidelines on the optimal timing of VTE prophylaxis.
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
- None
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
- •Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form;
- •Males or females, age 18 and older at the time of study screening;
- •American Society of Anesthesiologists (ASA) Class I-III (Appendix III);
- •Due to undergo major colorectal surgery via laparotomy or laparoscopy
排除标准
- •Mentally incompetent or unable or unwilling to provide informed consent or comply with study procedures;
- •American Society of Anesthesiologists (ASA) Class IV or V;
- •Children <18
- •Pregnant patients
- •Current/Active DVT
- •Patients on therapeutic anticoagulation for DVT or PE at time of surgery
- •Patients on anticoagulation for other medical problem (Heart Valve/atrial fibrillation) at the time of surgery
- •Patients with IVC filter
- •History of allergy to heparin products
- •History of heparin induced thrombocytopenia (HIT)
- •Patients with recent or active hemorrhage (GI/intracranial, etc) felt by the attending surgeon to be a contraindication to heparin thromboprophylaxis
- •Patients with Epidural analgesia
研究组 & 干预措施
Post-op Heparin
Postoperative venous thromboprophylaxis (Control Arm/current standard practice: subcutaneous Heparin 5000 units started 23 hours after the end of surgery and continued every 8 hours for the remainder of the patients hospital course
干预措施: Heparin (Drug)
Pre-op Heparin
Treatment arm: subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course
干预措施: Heparin (Drug)
结局指标
主要结局
Number of Participants With Postoperative VTE Within 48 Hours After Surgery
时间窗: 48 hour postop period
Number of participants with postoperative VTE (deep venous thrombosis (DVT) or pulmonary embolism (PE) as demonstrated by duplex sonography or high probability on ventilation-perfusion scan or CT chest angiography within 48 hour postop period
次要结局
- Number of Participants With VTE Within 30-day After Surgery(30 day postop period)
- Number of Participants With Surgical Complications(30 day postop period)
- Hospital Stay(30 day postop period)
- Number of Participants With Bleeding Complications(30 day postop period)
- Number of Participants With Postoperative Thrombocytopenia(30 day postop period)
研究者
Phillip Fleshner MD
Director of Colorectal Surgery Residency
Cedars-Sinai Medical Center