跳至主要内容
临床试验/NCT03244020
NCT03244020Enrolling By Invitation4 期

Low Molecular Weight Heparin Versus Aspirin for Venous Thromboembolism Prophylaxis in Orthopaedic Oncology

Massachusetts General Hospital10 个研究点 分布在 1 个国家目标入组 2,868 人开始时间: 2018年2月16日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
Enrolling By Invitation
入组人数
2,868
试验地点
10
主要终点
Venous thromboembolism

研究概览

简要总结

Aspirin and low molecular weight heparin (LMWH) are both commonly employed pharmacologic methods of venous thromboembolism (VTE) prophylaxis after orthopaedic surgery. Data comparing these two methods of VTE prophylaxis in patients undergoing pelvic/lower extremity orthopaedic surgery for malignancy are lacking, however, as compared to the data and guidelines present for VTE chemoprophylaxis after joint arthroplasty and hip fracture surgery. In this clinical trial, our specific aim is to compare the post operative incidence of VTE between patients receiving aspirin and LMWH after pelvic/lower extremity orthopaedic oncology procedures.

详细描述

Lower extremity orthopaedic surgery and malignancy are both known major risk factors for venous thromboembolism (VTE). Guidelines from high quality data exist with regards to VTE prophylaxis in patients undergoing orthopaedic surgery, particularly joint arthroplasty. Far fewer data are available regarding the efficacy of various methods of pharmacologic VTE prophylaxis in patients undergoing surgery for primary or metastatic musculoskeletal malignancies as malignancy itself is known to confer a hypercoagulable state. The existing data, including published data from our institution, are almost exclusively from retrospective studies. Given the limited external validity of existing guidelines and limitations inherent in applying data from retrospective studies, a randomized, prospective study comparing two of the most common methods of pharmacologic VTE prophylaxis would help to guide clinical care of this patient population. In addition, large dead spaces susceptible to hematoma formation are often created from tumor resections in orthopaedic oncology. Our retrospective data suggest that hematoma formation may be an independent predictor of infection. An important risk of chemical VTE prophylaxis is an increased incidence of bleeding into these dead spaces, leading to hematomas. This illustrates the complexity of selecting a method of VTE prophylaxis in patients at both high risk of VTE and hematoma formation and the need for high quality data to guide clinical decision-making in this patient population.

The specific aim of this study is to compare the post operative incidence of symptomatic deep vein thrombosis (DVT) and pulmonary embolus (PE) between patients who receive low molecular weight heparin (LMWH) versus aspirin for prophylaxis after having undergone pelvic or lower extremity orthopaedic oncology surgery (primary bone sarcomas, soft tissue sarcomas, and metastatic osseous disease).

Our secondary aim is to compare the incidence of hematoma formation and wound complications between these methods of pharmacologic prophylaxis in the aforementioned patient population.

Our hypothesis is that there is no significant difference in the incidence rate of symptomatic DVT/PE in patients administered LMWH versus aspirin for prophylaxis; however there may exist a difference in the rate of wound complications between these prophylaxis methods.

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

入选标准

  • 未提供

排除标准

  • Documented prior history of VTE.
  • Preoperative use of therapeutic or prophylactic chemical anticoagulation at the time of surgery.
  • Documented allergy/adverse reaction to either of the two study drugs.
  • Presence of inferior vena cava (IVC) filter.
  • Known, diagnosed hypercoagulable state (other than malignancy).
  • Inability to receive chemical anticoagulation.
  • Preoperative use of full-strength aspirin 325 mg daily; patients already taking aspirin 81 mg daily will not be excluded.
  • Inability for the patient him/herself to give informed consent due to delirium, dementia, or any other reason.
  • Fear of needles that prevents administration of LMWH.
  • Inability to administer medications via needles.
  • For patients with metastatic osseous disease, a Khorana score of ≥
  • Pregnancy testing, via a urine or blood test, is a routine part of pre-operative laboratory testing in patients scheduled to undergo orthopaedic surgeries. Attending surgeons may also choose to exclude any patient from randomization at their discretion.

研究组 & 干预措施

LMWH for Soft Tissue Sarcoma

Experimental

Patients undergoing surgery for pelvic/lower extremity soft tissue sarcomas and are randomized to Enoxaparin 40Mg/0.4mL prefilled syringe subcutaneous injection daily for VTE prophylaxis

干预措施: Enoxaparin 40Mg/0.4mL Prefilled Syringe (Drug)

ASA for Soft Tissue Sarcoma

Experimental

Patients undergoing surgery for pelvic/lower extremity soft tissue sarcomas and are randomized to aspirin 325 mg po daily for VTE prophylaxis

干预措施: Aspirin 325mg (Drug)

LMWH for Primary Bone Tumor

Experimental

Patients undergoing surgery for pelvic/lower extremity primary bone tumor and are randomized to Enoxaparin 40Mg/0.4mL prefilled syringe subcutaneous injection daily for VTE prophylaxis

干预措施: Enoxaparin 40Mg/0.4mL Prefilled Syringe (Drug)

ASA for Primary Bone Tumor

Experimental

Patients undergoing surgery for pelvic/lower extremity primary bone tumor and are randomized to aspirin 325 mg po daily for VTE prophylaxis

干预措施: Aspirin 325mg (Drug)

LMWH for Metastatic Disease

Experimental

Patients undergoing surgery for pelvic/lower extremity metastatic bone disease and are randomized to Enoxaparin 40Mg/0.4mL prefilled syringe subcutaneous injection daily for VTE prophylaxis

干预措施: Enoxaparin 40Mg/0.4mL Prefilled Syringe (Drug)

ASA for Metastatic Disease

Experimental

Patients undergoing surgery for pelvic/lower extremity metastatic bone disease and are randomized to aspirin 325 mg po daily for VTE prophylaxis

干预措施: Aspirin 325mg (Drug)

结局指标

主要结局

Venous thromboembolism

时间窗: Up to 3 or 6 months post operatively for bone/soft tissue sarcomas and metastatic osseous disease, respectively

Deep venous thrombosis; pulmonary embolus

次要结局

  • Infection(Up to 3 or 6 months post operatively for bone/soft tissue sarcomas and metastatic osseous disease, respectively)
  • Early chemoprophylaxis stop(Up to 4 weeks post operatively)
  • Hematoma formation(Up to 3 or 6 months post operatively for bone/soft tissue sarcomas and metastatic osseous disease, respectively)
  • Complication requiring return to operating room(Up to 3 or 6 months post operatively for bone/soft tissue sarcomas and metastatic osseous disease, respectively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Santiago Lozano-Calderon

Associate Professor of Orthopaedic Surgery

Massachusetts General Hospital

研究点 (10)

Loading locations...

相似试验

LMWH vs Aspirin for VTE Prophylaxis in Orthopaedic... | 临床试验