Clinical trial NCT03862755: Chemoprophylaxis Plus Early Ambulation
Official title: Chemoprophylaxis Plus Early Ambulation Prevent Chinese Thoracic Surgery Patients From Pulmonary Embolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Embolism
Thoracic Surgery
Keywords: Pulmonary embolism
Thoracic surgery
Thromboprophylaxis
Lead sponsor: Shanghai Pulmonary Hospital, Shanghai, China
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 581
Sex: ALL
Minimum age (years): 14
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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).
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* Lung surgical patients who were sent to thoracic postoperative intensive care unit (ICU) ward right after surgery and stayed in ICU for at least 24 hours.

Exclusion Criteria:

* Cases received inferior vena filter and anti-coagulation treatment history.

Primary outcomes:
measure: Incidence of Postoperative Pulmonary Embolism (PE) in Surgical Thoracic Patients Under Currently Used PE Prevention Strategies.
timeFrame: up to 8 weeks post operation
Secondary outcomes:
measure: Provider Adherence in Implementation of PE Prevention Strategies.
timeFrame: Through study completion, an average of 1 month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Pulmonary Hospital, Shanghai, China
name: Gening Jiang
role: STUDY_CHAIR
References: