Clinical trial NCT03862755
Conditions: Pulmonary Embolism Thoracic Surgery
Keywords: Pulmonary embolism Thoracic surgery Thromboprophylaxis
Sponsor: Shen Lei
Start date: 2017-08-08; Completion date: 2017-11-11
Enrollment: 581 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief 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.

Arms: arm 1: All surgical patients classified into low risk and moderate/high risk groups based on Caprini score and received different thromboprophylaxis strategies Briefly, early ambulation alone was used in patients at low risk, early ambulation plus chemoprophylaxis with Low Molecular Weight Heparin was used in patients at moderate/high risk.
Interventions: intervention 1: Chemoprophylaxis with Low Molecular Weight Heparin (LMWH)
Intervention descriptions: intervention 1: 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).

Protocol documents:
Prot_SAP_002.pdf: 
Study Protocol and Statistical Analysis Plan 
Title: Chemoprophylaxis Plus Early Ambulation Prevent Chinese Thoracic Surgery 
Patients from Pulmonary Embolism 
NCT number: 03862755 
Date of document: July 10, 2020 
 
 


study Protocol 
Objective: 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. 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. The 
investigators wanted to establish if the prophylaxis measures what they were using 
currently are suitable for Chinese thoracic surgical patients. 
Methods: Single Group Assignment 
Early chemoprophylaxis means low-molecular weight heparin (LMWH) 3075 IU 
(WHO Units) injection subcutaneously QD 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). 


Randomization: Open Label 
Outcomes: 
Major outcome: Incidence of Postoperative Pulmonary Embolism (PE) in Surgical 
Thoracic Patients Under Currently Used PE Prevention Strategies. 
Minor outcome: Provider Adherence in Implementation of PE Prevention 
Strategies.  
Safety outcome: Major bleeding until 2 days after the last intake of injection. 
Sample size: 581 cases. 
1. Statistical Analysis Plan 
Data description: Results were presented as means ± standard deviation (SD). The 
independent-samples t test was used for continuous variables. The chi-square 
test and the Fisher’s exact test was used for categorical variables. Spearman 
correlation and multivariable logistic regression was performed for prediction 
analyses and to explain the relationship between variables.  
Missing data: Missing data will be deleted when analyzed. 
Statistical value：A P value <0.05 was considered statistically significant. 
Statistical software: SPSS 25.0