Pulmonary Embolism, Thoracic Surgery
Conditions
Keywords
Pulmonary embolism, Thoracic surgery, Thromboprophylaxis
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.
Interventions
DRUGChemoprophylaxis with Low Molecular Weight Heparin (LMWH)
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).
Sponsors
Shen Lei
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
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).
Eligibility
Sex/Gender
ALL
Age
14 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Pulmonary Embolism (PE) in Surgical Thoracic Patients Under Currently Used PE Prevention Strategies. | up to 8 weeks post operation | Real number of PE cases are recorded. PE cases are confirmed by computed tomographic pulmonary angiography (CTPA). During hospitalization, on postoperative 30 days and 60 days, PE incidence is recorded and compared with that of some retrospective patients group. Investigators will study if currently used prevention strategies are effective to prevent PE. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Provider Adherence in Implementation of PE Prevention Strategies. | Through study completion, an average of 1 month | Since thromboprophylaxis is often underused in China, investigators want to investigate provider adherence in complying with thromboprophylaxis implementation. Some provider, mainly surgeon, don't comply with currently used prevention strategies. Based on real prevention methods that patients have received during postoperative period, provider adherence are shown as percentage. When analyzing data, investigators need to exclude those patients who didn't receive proper prevention according to our guidelines from whole patients group. By studying adherence outcome, investigators will know in what extent the surgeon's decision will influence the result. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Thromboprophylaxis 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.
Chemoprophylaxis with Low Molecular Weight Heparin (LMWH): 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). | 581 |
| Total | 581 |
Baseline characteristics
| Characteristic | Thromboprophylaxis | — |
|---|---|---|
| Age, Continuous | 58.8 years STANDARD_DEVIATION 11.2 | — |
| Body mass index | 23.3 kg/m2 STANDARD_DEVIATION 3.2 | — |
| Length of Hospital Stay | 8.8 days STANDARD_DEVIATION 3.6 | — |
| Length of ICU stay | 1.2 days STANDARD_DEVIATION 0.6 | — |
| Pathologic diagnosis Benign | 148 participants | — |
| Pathologic diagnosis Malignant | 433 participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment China | 581 participants | — |
| Sex: Female, Male Female | 293 Participants | — |
| Sex: Female, Male Male | 288 Participants | — |
| Surgical procedure Extended Lobectomy | 25 participants | — |
| Surgical procedure Lobectomy | 368 participants | — |
| Surgical procedure Sub-lobar resections | 188 participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 581 |
| other Total, other adverse events | 0 / 581 |
| serious Total, serious adverse events | 0 / 581 |
Outcome results
Primary
Incidence of Postoperative Pulmonary Embolism (PE) in Surgical Thoracic Patients Under Currently Used PE Prevention Strategies.
Real number of PE cases are recorded. PE cases are confirmed by computed tomographic pulmonary angiography (CTPA). During hospitalization, on postoperative 30 days and 60 days, PE incidence is recorded and compared with that of some retrospective patients group. Investigators will study if currently used prevention strategies are effective to prevent PE.
Time frame: up to 8 weeks post operation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Thromboprophylaxis | Incidence of Postoperative Pulmonary Embolism (PE) in Surgical Thoracic Patients Under Currently Used PE Prevention Strategies. | 3 Participants |
Secondary
Provider Adherence in Implementation of PE Prevention Strategies.
Since thromboprophylaxis is often underused in China, investigators want to investigate provider adherence in complying with thromboprophylaxis implementation. Some provider, mainly surgeon, don't comply with currently used prevention strategies. Based on real prevention methods that patients have received during postoperative period, provider adherence are shown as percentage. When analyzing data, investigators need to exclude those patients who didn't receive proper prevention according to our guidelines from whole patients group. By studying adherence outcome, investigators will know in what extent the surgeon's decision will influence the result.
Time frame: Through study completion, an average of 1 month
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Thromboprophylaxis | Provider Adherence in Implementation of PE Prevention Strategies. | Compliance | 306 Participants |
| Thromboprophylaxis | Provider Adherence in Implementation of PE Prevention Strategies. | Non-compliance | 275 Participants |