Chemoprophylaxis Plus Early Ambulation

NCT03862755 | Completed Phase 4 Results FDA Drug

• 1 other identifier: PE Prevention in SPH
• Study Type: interventional
• Target: 581
• Locations: 1 country
• Sites: 1

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.

Conditions

Pulmonary Embolism; Thoracic Surgery

Keywords

Pulmonary embolism; Thoracic surgery; Thromboprophylaxis

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 8 weeks post operation

Secondary Outcomes (1)

• Provider Adherence in Implementation of PE Prevention Strategies.

  Through study completion, an average of 1 month

Study Arms (1)

Thromboprophylaxis

EXPERIMENTAL

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.

Drug: Chemoprophylaxis with Low Molecular Weight Heparin (LMWH)

Interventions

Chemoprophylaxis with Low Molecular Weight Heparin (LMWH) DRUG

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).

Also known as: Early ambulation

Thromboprophylaxis

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Shen Lei: lead

Study Sites (1)

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Chemoprevention; Heparin, Low-Molecular-Weight; Early Ambulation

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care

Results Point of Contact

• Title: Dr. Lei Shen
• Organization: Shanghai Pulmonary Hospital

sh_leisen@126.com

86-21-65115006

Study Officials

• Gening Jiang

  Shanghai Pulmonary Hospital, Shanghai, China

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associated Professor

Model Details: 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).

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: March 5, 2019
• Study Start: August 8, 2017
• Primary Completion: September 12, 2017
• Study Completion: November 11, 2017
• Last Updated: November 2, 2021
• Results First Posted: November 2, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)