Trial Outcomes & Findings for Chemoprophylaxis Plus Early Ambulation (NCT NCT03862755)

Last Updated: 2021-11-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

581 participants

Primary outcome timeframe

up to 8 weeks post operation

Results posted on

2021-11-02

Participant Flow

Participant milestones

Participant milestones
Measure	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).
Overall Study STARTED	581
Overall Study COMPLETED	581
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Thromboprophylaxis n=581 Participants 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).
Age, Continuous	58.8 years STANDARD_DEVIATION 11.2 • n=581 Participants
Sex: Female, Male Female	293 Participants n=581 Participants
Sex: Female, Male Male	288 Participants n=581 Participants
Region of Enrollment China	581 participants n=581 Participants
Body mass index	23.3 kg/m2 STANDARD_DEVIATION 3.2 • n=581 Participants
Pathologic diagnosis Malignant	433 participants n=581 Participants
Pathologic diagnosis Benign	148 participants n=581 Participants
Surgical procedure Sub-lobar resections	188 participants n=581 Participants
Surgical procedure Lobectomy	368 participants n=581 Participants
Surgical procedure Extended Lobectomy	25 participants n=581 Participants
Length of ICU stay	1.2 days STANDARD_DEVIATION 0.6 • n=581 Participants
Length of Hospital Stay	8.8 days STANDARD_DEVIATION 3.6 • n=581 Participants

PRIMARY outcome

Timeframe: up to 8 weeks post operation

Outcome measures

Outcome measures
Measure	Thromboprophylaxis n=581 Participants 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).
Incidence of Postoperative Pulmonary Embolism (PE) in Surgical Thoracic Patients Under Currently Used PE Prevention Strategies.	3 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Thromboprophylaxis n=581 Participants 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).
Provider Adherence in Implementation of PE Prevention Strategies. Compliance	306 Participants
Provider Adherence in Implementation of PE Prevention Strategies. Non-compliance	275 Participants

Adverse Events

Thromboprophylaxis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lei Shen

Shanghai Pulmonary Hospital

Phone: 86-21-65115006

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place