Clinical trial NCT02430207: Incidence of Pulmonary Embolism During Temporary Pacing Via Femoral Versus Subclavian Vein
Official title: Study of Incidence of Pulmonary Embolism During Peroperative Period of Temporary Pacing Via Femoral Vein Versus Subclavian Vein in China
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pulmonary Embolism
Keywords: Pulmonary Embolism
Temporary Pacing
Femoral Vein
Subclavian Vein
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Suqian People's Hospital
name: The First People's Hospital of Kunshan
name: Danyang People's Hospital of Jiangsu Province
name: Jiangsu Taizhou People's Hospital
name: Xinghua People's Hospital
name: Jiangyin People's Hospital
name: Qidong People's Hospital
name: Wuxi No. 2 People's Hospital
name: Nantong No. 1 People's Hospital
name: Changzhou No.2 People's Hospital
name: Xuzhou Medical University
name: Jiangsu Province Hospital of Traditional Chinese Medicine
name: Northern Jiangsu People's Hospital
name: Rugao People's Hospital
name: Xuzhou Central Hospital
First posted: 2015-04-30
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. This randomized and multi-center study was designed to verify whether temporary pacing via subclavian vein has lower incidence than via femoral vein.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of participants suffering from pulmonary embolism
timeFrame: 12 hours to 7 days after extraction of temporary pacing leads
Secondary outcomes:
measure: Percentage of participants suffering from deep vein thrombosis
timeFrame: 12 hours to 7 days after extraction of temporary pacing leads
Other outcomes:
Locations:
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Minglong Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Gammage MD. Temporary cardiac pacing. Heart. 2000 Jun;83(6):715-20. doi: 10.1136/heart.83.6.715. No abstract available.
citation: FURMAN 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.
citation: Cheng 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.
citation: Weinstein 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.
citation: Pandian 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.
citation: Nolewajka 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.
citation: Lopez 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.
citation: Klatsky 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.
citation: Torbicki 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.