Application of Hemostatic Agent “Haemoblock” for Pocket Hematoma Reduction. Design of the PEGAS study: a Multicenter Clinical Trial

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Abstract

Pocket hematoma (PH) is a common complication of pacemaker implantations which prolongs hospitalization and may demand surgical revision in some cases. According to the data from different researchers PH rate varies from 2 to 7%. It depends on number of factors including a need for anticoagulation therapy. We present a review of design of multicenter clinical trial evaluating safety and efficacy of application of hemostatic agent “Haemoblock” for pocket hematoma reduction in patients taking oral anticoagulants.

About the authors

Anatoly A. Nechepurenko

Federal Center for Cardiovascular Surgery

Author for correspondence.
Email: vestik@mail.ru
ORCID iD: 0000-0001-5722-9883
SPIN-code: 5582-8428

candidate of medical sciences

Russian Federation, Astrakhan

Nikolay N. Ilov

НЕ Astrakhan SMU МОН Russia

Email: nikolay.ilov@gmail.com
ORCID iD: 0000-0003-1294-9646
SPIN-code: 7426-3796

candidate of medical sciences

Russian Federation, Astrakhan

Sergei S. Durmanov

Federal Center for Cardiovascular Surgery

Email: ssd58@yandx.ru
ORCID iD: 0000-0002-4973-510X

candidate of medical sciences

Russian Federation, Penza

Pavel L. Shugaev

Federal Center for Cardiovascular Surgery

Email: doc.shugaev@gmail.com
ORCID iD: 0000-0002-5055-6838
SPIN-code: 7293-8980

candidate of medical sciences

Russian Federation, Chelyabinsk

Andrey V. Ivanchenko

Federal Center for high medical technologies

Email: ivancha74@gmail.ru
ORCID iD: 0000-0001-5501-4926
Russian Federation, Kaliningrad

Igor' A. Suchkov

Ryazan State Medical University

Email: suchkov_med@mail.ru
ORCID iD: 0000-0002-1292-5452
SPIN-code: 6473-8662

doctor of medical sciences

Russian Federation, Ryazan

Khosni A. Bsharat

Federal Center for Cardiovascular Surgery

Email: hosni@mail.ru
ORCID iD: 0000-0002-1366-9294
SPIN-code: 1374-8371

candidate of medical sciences

Russian Federation, Khabarovsk

Andrey M. Lukin

Moscow Regional Scientific Research Institute of Blood

Email: look7in@yandex.ru
Russian Federation, Moscow

Lyudmila G. Medyanсeva

Federal Center for Cardiovascular Surgery

Email: medastra@rambler.ru
ORCID iD: 0000-0002-8485-6636
SPIN-code: 5010-7870

candidate of medical sciences

Russian Federation, Astrakhan

Vladislav O. Povarov

Ryazan State Cardiological Dispensary

Email: povarov.vladislav@mail.ru
ORCID iD: 0000-0001-8810-9518
SPIN-code: 2873-1391

candidate of medical sciences

Russian Federation, Ryazan

References

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  2. Notaristefano F, Angeli F, Verdecchia P, et al. Device-pocket hematoma after cardiac implantable electronic devices. Circ Arrhythm Electrophysiol. 2020;13(4):361–363. doi: 10.1161/CIRCEP.120.008372
  3. De Sensi F, Miracapillo G, Cresti A, et al. Pocket hematoma: a call for definition. Pacing Clin Electrophysiol. 2015;38(8):909–913. doi: 10.1111/pace.12665
  4. Essebag V, Verma A, Healey JS, et al. Clinically significant pocket hematoma increases long-term risk of device infection: BRUISE CONTROL INFECTION study. J Am Coll Cardiol. 2016;67(11): 1300–1308. doi: 10.1016/j.jacc.2016.01.009
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  6. Essebag V, Healey JS, Joza J, et al. Effect of direct oral anticoagulants, warfarin, and an-tiplatelet agents on risk of device pocket hematoma: Combined analysis of BRUISE CON-TROL 1 and 2. Circ Arrhythm Electrophysiol. 2019;12(10):e007545. doi: 10.1161/CIRCEP.119.007545
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  13. Degovtsov EN, Kolyadko PV, Kolyadko VP, Satinov AV. first results of a randomized controlled trial of hemoblock in patients with large incisional hernias. Russian Sklifosovsky Journal of Emergency Medical Care. 2019;8(4):430–436. (In Russ.). doi: 10.23934/2223-9022-2019-8-4-430-436
  14. Kolesov SV, Grin AA, Slinyakov LY, et al. Efficiency of using polyacrylic acid silver salt in decompression and stabilization surgery on the lumbar spine involving 1 to 3 segments. Spine Surgery. 2019;16(2):73–80. (In Russ.). doi: 10.14531/ss2019.2.73–80
  15. Revishvili ASh, Shlyakhto EV, Popov SV, et al. Clinical recommendations for the use of electrophysiological study, catheter ablation and implantable cardiac electronic devices. Moscow; 2017. (In Russ.).
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Supplementary files

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2. Fig. 1. Study design

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Copyright (c) 2021 Nechepurenko A.A., Ilov N.N., Durmanov S.S., Shugaev P.L., Ivanchenko A.V., Suchkov I.A., Bsharat K.A., Lukin A.M., Medyanсeva L.G., Povarov V.O.

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