Pulmonary EmbolismNCT02430207
Incidence of Pulmonary Embolism During Temporary Pacing Via Femoral Versus Subclavian Vein
A study testing temporary pacing femoral vein and temporary pacing subclavian vein in people with Pulmonary Embolism, run by The First Affiliated Hospital with Nanjing Medical University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- temporary pacing femoral vein and temporary pacing subclavian vein
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- No sites listed yet
- Study dates
- May 2015to May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Pulmonary Embolism
- Being tested
- temporary pacing femoral vein, temporary pacing subclavian vein
- Keywords
- Pulmonary Embolism, Temporary Pacing, Femoral Vein, Subclavian Vein
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
temporary pacing femoral veinProcedure or surgery
Temporary pacing via femoral or subclavian vein
temporary pacing subclavian veinProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Femoral Vein | Experimental | patients receiving temporary pacing via femoral vein Receives: Procedure: temporary pacing femoral vein |
| Subclavian Vein | Experimental | patients receiving temporary pacing via subclavian vein Receives: Procedure: temporary pacing subclavian vein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of participants suffering from pulmonary embolism
Measured: 12 hours to 7 days after extraction of temporary pacing leads
Secondary outcomes (1)
Percentage of participants suffering from deep vein thrombosis
Measured: 12 hours to 7 days after extraction of temporary pacing leads
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital with Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Suqian People's Hospital, The First People's Hospital of Kunshan, Danyang People's Hospital of Jiangsu Province, Jiangsu Taizhou People's Hospital, Xinghua People's Hospital, Jiangyin People's Hospital, Qidong People's Hospital, Wuxi No. 2 People's Hospital, Nantong No. 1 People's Hospital, Changzhou No.2 People's Hospital, Xuzhou Medical University, Jiangsu Province Hospital of Traditional Chinese Medicine, Northern Jiangsu People's Hospital, Rugao People's Hospital, Xuzhou Central Hospital
- Responsible party
- Principal investigator, Minglong Chen, The First Affiliated Hospital with Nanjing Medical University
- Investigators
- Minglong Chen, M.D., Principal investigator, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02430207
- Sponsor's protocol ID
- KFSN201407
- Status last verified
- Apr 2015
- First submitted
- 21 Apr 2015
- Last updated
- 19 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
ZOLL PM. Resuscitation of the heart in ventricular standstill by external electric stimulation. N Engl J Med. 1952 Nov 13;247(20):768-71. doi: 10.1056/NEJM195211132472005. No abstract available.
PubMed 13002611Gammage MD. Temporary cardiac pacing. Heart. 2000 Jun;83(6):715-20. doi: 10.1136/heart.83.6.715. No abstract available.
PubMed 10814641FURMAN S, SCHWEDEL JB. An intracardiac pacemaker for Stokes-Adams seizures. N Engl J Med. 1959 Nov 5;261:943-8. doi: 10.1056/NEJM195911052611904. No abstract available.
PubMed 13825713Cheng TO. Percutaneous transfemoral venous cardiac pacing. A simple and practical method. Chest. 1971 Jul;60(1):73-8. doi: 10.1378/chest.60.1.73. No abstract available.
PubMed 5571275Weinstein J, Gnoj J, Mazzara JT, Ayres SM, Grace WJ. Temporary transvenous pacing via the percutaneous femoral vein approach. A prospective study of 100 cases. Am Heart J. 1973 May;85(5):695-705. doi: 10.1016/0002-8703(73)90178-6. No abstract available.
PubMed 4697639Pandian NG, Kosowsky BD, Gurewich V. Transfemoral temporary pacing and deep vein thrombosis. Am Heart J. 1980 Dec;100(6 Pt 1):847-51. doi: 10.1016/0002-8703(80)90065-4.
PubMed 7446387Nolewajka AJ, Goddard MD, Brown TC. Temporary transvenous pacing and femoral vein thrombosis. Circulation. 1980 Sep;62(3):646-50. doi: 10.1161/01.cir.62.3.646.
PubMed 7398027Lopez Ayerbe J, Villuendas Sabate R, Garcia Garcia C, Rodriguez Leor O, Gomez Perez M, Curos Abadal A, Serra Flores J, Larrousse E, Valle V. [Temporary pacemakers: current use and complications]. Rev Esp Cardiol. 2004 Nov;57(11):1045-52. Spanish.
PubMed 15544753Klatsky AL, Armstrong MA, Poggi J. Risk of pulmonary embolism and/or deep venous thrombosis in Asian-Americans. Am J Cardiol. 2000 Jun 1;85(11):1334-7. doi: 10.1016/s0002-9149(00)00766-9.
PubMed 10831950Torbicki A, Perrier A, Konstantinides S, Agnelli G, Galie N, Pruszczyk P, Bengel F, Brady AJ, Ferreira D, Janssens U, Klepetko W, Mayer E, Remy-Jardin M, Bassand JP; ESC Committee for Practice Guidelines (CPG). Guidelines on the diagnosis and management of acute pulmonary embolism: the Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC). Eur Heart J. 2008 Sep;29(18):2276-315. doi: 10.1093/eurheartj/ehn310. Epub 2008 Aug 30.
PubMed 18757870
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Incidence of Pulmonary Embolism During Peroperative Period of Temporary Pacing Via Femoral Vein Versus Subclavian Vein in China
- ClinicalTrials.gov ID
- NCT02430207
- Acronym / sponsor ID
- KFSN201407
- Conditions
- Pulmonary Embolism
- Keywords
- Pulmonary Embolism, Temporary Pacing, Femoral Vein, Subclavian Vein
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Suqian People's Hospital, The First People's Hospital of Kunshan, Danyang People's Hospital of Jiangsu Province, Jiangsu Taizhou People's Hospital, Xinghua People's Hospital, Jiangyin People's Hospital, Qidong People's Hospital, Wuxi No. 2 People's Hospital, Nantong No. 1 People's Hospital, Changzhou No.2 People's Hospital, Xuzhou Medical University, Jiangsu Province Hospital of Traditional Chinese Medicine, Northern Jiangsu People's Hospital, Rugao People's Hospital, Xuzhou Central Hospital
- Study start
- May 2015
- Primary completion
- May 2016 (estimated)
- First posted
- 30 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Femoral Vein | Experimental | Procedure: temporary pacing femoral veinpatients receiving temporary pacing via femoral vein |
| Subclavian Vein | Experimental | Procedure: temporary pacing subclavian veinpatients receiving temporary pacing via subclavian vein |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| temporary pacing femoral veinTemporary pacing via femoral or subclavian vein | Procedure or surgery | Femoral Vein |
| temporary pacing subclavian vein | Procedure or surgery | Subclavian Vein |
Primary outcome
Percentage of participants suffering from pulmonary embolism
Time frame: 12 hours to 7 days after extraction of temporary pacing leads
1 secondary outcome
Percentage of participants suffering from deep vein thrombosis
Time frame: 12 hours to 7 days after extraction of temporary pacing leads
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2016.
- Background: PubMed 13002611ZOLL PM. Resuscitation of the heart in ventricular standstill by external electric stimulation. N Engl J Med. 1952 Nov 13;247(20):768-71. doi: 10.1056/NEJM195211132472005. No abstract available.
- Background: PubMed 10814641Gammage MD. Temporary cardiac pacing. Heart. 2000 Jun;83(6):715-20. doi: 10.1136/heart.83.6.715. No abstract available.
- Background: PubMed 13825713FURMAN S, SCHWEDEL JB. An intracardiac pacemaker for Stokes-Adams seizures. N Engl J Med. 1959 Nov 5;261:943-8. doi: 10.1056/NEJM195911052611904. No abstract available.
- Background: PubMed 5571275Cheng TO. Percutaneous transfemoral venous cardiac pacing. A simple and practical method. Chest. 1971 Jul;60(1):73-8. doi: 10.1378/chest.60.1.73. No abstract available.
- Background: PubMed 4697639Weinstein J, Gnoj J, Mazzara JT, Ayres SM, Grace WJ. Temporary transvenous pacing via the percutaneous femoral vein approach. A prospective study of 100 cases. Am Heart J. 1973 May;85(5):695-705. doi: 10.1016/0002-8703(73)90178-6. No abstract available.
- Background: PubMed 7446387Pandian NG, Kosowsky BD, Gurewich V. Transfemoral temporary pacing and deep vein thrombosis. Am Heart J. 1980 Dec;100(6 Pt 1):847-51. doi: 10.1016/0002-8703(80)90065-4.
- Background: PubMed 7398027Nolewajka AJ, Goddard MD, Brown TC. Temporary transvenous pacing and femoral vein thrombosis. Circulation. 1980 Sep;62(3):646-50. doi: 10.1161/01.cir.62.3.646.
- Background: PubMed 15544753Lopez Ayerbe J, Villuendas Sabate R, Garcia Garcia C, Rodriguez Leor O, Gomez Perez M, Curos Abadal A, Serra Flores J, Larrousse E, Valle V. [Temporary pacemakers: current use and complications]. Rev Esp Cardiol. 2004 Nov;57(11):1045-52. Spanish.
- Background: PubMed 10831950Klatsky AL, Armstrong MA, Poggi J. Risk of pulmonary embolism and/or deep venous thrombosis in Asian-Americans. Am J Cardiol. 2000 Jun 1;85(11):1334-7. doi: 10.1016/s0002-9149(00)00766-9.
- Background: PubMed 18757870Torbicki A, Perrier A, Konstantinides S, Agnelli G, Galie N, Pruszczyk P, Bengel F, Brady AJ, Ferreira D, Janssens U, Klepetko W, Mayer E, Remy-Jardin M, Bassand JP; ESC Committee for Practice Guidelines (CPG). Guidelines on the diagnosis and management of acute pulmonary embolism: the Task Force for the Diagnosis and Management of Acute Pulmonary Embolism of the European Society of Cardiology (ESC). Eur Heart J. 2008 Sep;29(18):2276-315. doi: 10.1093/eurheartj/ehn310. Epub 2008 Aug 30.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Minglong Chen, M.D. principal investigator
The First Affiliated Hospital with Nanjing Medical University
Questions about this trial
What is this clinical trial studying?
A study testing temporary pacing femoral vein and temporary pacing subclavian vein in people with Pulmonary Embolism, run by The First Affiliated Hospital with Nanjing Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kai Gu, M.D. (0086 25 68136965, gukaiwang@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants suffering from pulmonary embolism (time frame: 12 hours to 7 days after extraction of temporary pacing leads). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02430207, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2016.