Chemoprophylaxis Plus Early Ambulation
Condition: Pulmonary Embolism; Thoracic Surgery
MeSH terms: Pulmonary Embolism; Embolism
Study type: Interventional
Phase: Phase 4

Summary: 
      Pulmonary embolism (PE) can be a devastating postoperative complication and the leading cause
      of mortality after thoracic surgery. PE together with deep venous thrombosis (DVT) is called
      venous thromboembolism (VTE), whereas PE caused much more serious situation than DVT. Huge
      amount of data have demonstrated that thromboprophylaxis after surgery is very important to
      prevent postoperative VTE, especially after orthopedic surgery and plaster surgery. Moreover,
      for thoracic surgery, American College of Chest Physicians (ACCP) has published prevention
      guidelines of VTE in non-orthopedic surgical patients and has been used widely, but
      unfortunately prophylaxis measures had often been underused in China. However, to be honest,
      there could be a big difference between Chinese and western populations, for example, what
      guidelines recommended thrombolysis therapy in diagnosed massive or sub-massive PE patients
      is tissue type plasminogen activator (t-PA) 100 mg, while in China 50 mg has the same effect.
      So investigators wanted to establish if the prophylaxis measures what they were using
      currently are suitable for Chinese thoracic surgical patients.
    

Detailed description: 
      Investigators enrolled 598 patients who were sent to thoracic postoperative intensive care
      unit (ICU) ward right after surgery from August 8 to September 12 of 2017 and those patients
      stayed in ICU for at least 24 hours. Excluded non-lung surgery there were 581 lung surgery
      cases. Investigators adopted the Caprini VTE risk assessment model from Boston Medical Center
      (BMC) in United States of America (USA). According to different risk level, participants
      received different thromboprophylaxis strategies. Early ambulation alone was for patients at
      low risk (Caprini 0-4), early chemoprophylaxis plus early ambulation was for patients at
      moderate (Caprini 5-8) or high risk (Caprini ≥9). Early chemoprophylaxis means low-molecular
      weight heparin (LMWH) 3075 IU (WHO Units) injection subcutaneously one time a day no later
      than 24 hours after surgery. Early ambulation means activity out of bed no later than 24
      hours after surgery. Thromboprophylaxis contraindication included chest tube drainage more
      than 500 ml or major bleeding during operation or surgeons refusing to use thromboprophylaxis
      because they thought that patients would benefit more from not performing early ambulation or
      chemoprophylaxis. Some patients received chemoprophylaxis after they moved back to regular
      ward out of ICU which was called late chemoprophylaxis which means more than 24 hours after
      surgery. All chemoprophylaxis were used only during hospitalization. When participants were
      discharged, no extended treatment prescribed. However, they were followed up twice on 30 days
      and 60 days after surgery by phone call.
    

Intervention name(s): Chemoprophylaxis with Low Molecular Weight Heparin (LMWH)
Intervention type(s): Drug
Intervention description(s): Early chemoprophylaxis means low-molecular weight heparin (LMWH) 3075 IU (WHO Units) injection subcutaneously one time a day no later than 24 hours after surgery. Early ambulation means activity out of bed no later than 24 hours after surgery. According to different risk level, patients received different thromboprophylaxis strategies. Early ambulation alone was for patients at low risk (Caprini 0-4), early chemoprophylaxis plus early ambulation was for patients at moderate (Caprini 5-8) or high risk (Caprini ≥9).
Other intervention name(s): Early ambulation
Intervention MeSH terms: Heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Dalteparin
Intervention model: Single Group Assignment
Intervention model description: Early chemoprophylaxis means low-molecular weight heparin (LMWH) 3075 IU (WHO Units) injection subcutaneously one time a day no later than 24 hours after surgery. Early ambulation means activity out of bed no later than 24 hours after surgery. According to different risk level, patients received different thromboprophylaxis strategies. Early ambulation alone was for patients at low risk (Caprini 0-4), early chemoprophylaxis plus early ambulation was for patients at moderate (Caprini 5-8) or high risk (Caprini ≥9).
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Pulmonary embolism; Thoracic surgery; Thromboprophylaxis