Incidence of Pulmonary Embolism During Temporary Pacing Via Femoral Versus Subclavian Vein

February 18, 2016 updated by: Minglong Chen, The First Affiliated Hospital with Nanjing Medical University

Study of Incidence of Pulmonary Embolism During Peroperative Period of Temporary Pacing Via Femoral Vein Versus Subclavian Vein in China

Temporary pacing via femoral vein is used widely in mainland China, because of its feasibility and simplicity. However, pulmonary embolism often occurred after the procedure. It is not known that whether there was any difference in incidence of pulmonary embolism between via different approaches. This randomized and multi-center study was designed to verify whether temporary pacing via subclavian vein has lower incidence than via femoral vein.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years old or older
  • There is indication for temporary pacing
  • Patients agreed to participate in the clinical trial and sign a written informed consent

Exclusion Criteria:

  • History of pulmonary embolism or deep vein thrombosis
  • Devices existing in vein system
  • Patients who could not receive randomization
  • Severe coagulation disorder
  • Severe liver, kidney dysfunction
  • Mental diseases
  • Pregnancy
  • Patients investigators believed not suitable for enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Femoral Vein
patients receiving temporary pacing via femoral vein
Procedure: temporary pacing femoral vein
Temporary pacing via femoral or subclavian vein
EXPERIMENTAL: Subclavian Vein
patients receiving temporary pacing via subclavian vein
Procedure: temporary pacing subclavian vein

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants suffering from pulmonary embolism
Time Frame: 12 hours to 7 days after extraction of temporary pacing leads
12 hours to 7 days after extraction of temporary pacing leads

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants suffering from deep vein thrombosis
Time Frame: 12 hours to 7 days after extraction of temporary pacing leads
12 hours to 7 days after extraction of temporary pacing leads

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Affiliated Hospital with Nanjing Medical University

Collaborators

Jiangsu Province Hospital of Traditional Chinese Medicine
Xuzhou Medical University
Xuzhou Central Hospital
Northern Jiangsu Province People's Hospital
Jiangyin People's Hospital
Changzhou No.2 People's Hospital
Jiangsu Taizhou People's Hospital
The First People's Hospital of Kunshan
Wuxi No. 2 People's Hospital
Suqian People's Hospital
Danyang People's Hospital of Jiangsu Province
Xinghua People's Hospital
Qidong People's Hospital
Nantong No. 1 People's Hospital
Rugao People's Hospital

Investigators

  • Principal Investigator: Minglong Chen, M.D., The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (ANTICIPATED)

May 1, 2016

Study Registration Dates

First Submitted

April 21, 2015

First Submitted That Met QC Criteria

April 29, 2015

First Posted (ESTIMATE)

April 30, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

February 19, 2016

Last Update Submitted That Met QC Criteria

February 18, 2016

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KFSN201407

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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