Study Results
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Basic Information
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COMPLETED
200 participants
OBSERVATIONAL
2021-01-01
2023-11-01
Brief Summary
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The use of local hemostatic drugs is one of the promising directions for increasing the efficiency of intraoperative hemostasis. The haemostatic solution "Haemoblock" has shown its hemostatic potential in general surgical practice. The possibilities of "Haemoblock" in the prevention of pocket hematoma have not been studied. The hemostatic effect of "Haemoblock" is achieved within 1-2 minutes due to the formation of a clot with blood plasma proteins, first of all with albumin. As a result of the action of the "Haemoblock", a strong polymethacrylate membrane is formed on the surface of the wound, which, among other things, has a bactericidal effect.
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Detailed Description
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* Ryazan State Medical University (Ryazan);
* Federal State Budgetary Institution "Federal Center for Cardiovascular Surgery" of the Ministry of Health of the Russian Federation (Astrakhan);
* Federal State Budgetary Institution "Federal Center for Cardiovascular Surgery" of the Ministry of Health of the Russian Federation (Penza);
* Federal State Budgetary Institution "Federal Center for Cardiovascular Surgery" of the Ministry of Health of the Russian Federation (Chelyabinsk);
* Federal State Budgetary Institution "Federal Center for Cardiovascular Surgery" of the Ministry of Health of the Russian Federation (Kaliningrad);
* Federal State Budgetary Institution "Federal Center for Cardiovascular Surgery" of the Ministry of Health of the Russian Federation (Khabarovsk).
Haemostatic solution "Haemoblock" provided by Autonomous non-profit organization "MOSCOW REGIONAL SCIENTIFIC RESEARCH INSTITUTE OF BLOOD".
The study will include 200 patients with indications for pacemaker implantation (atrioventricular block, sick sinus syndrome, atrial fibrillation with impaired atrioventricular conduction or other).
Before starting the study, the patient must give written consent to participate in this study after familiarizing him with the purpose and rules of the clinical study.
All patients during randomisation will be divided into 2 groups:
Group A "Haemoblock" - 100 patients. Haemostatic solution "Haemoblock" will be used after pocket formation during pacemaker implantation (sterile gauze swabs are soaked in 15 ml of "Haemoblock" solution and applied in pacemaker pocket, then pacemaker pocket will be irrigated with 5 ml of "Haemoblock" solution without rinsing).
Group B "Control" - 100 patients. Same procedure will be performed with saline solution in this group.
Before surgery blood sampling, echocardiography will be performed in all patients.
3-5 days after surgery ultrasound of pacemaker pocket will be performed in all patients.
The observation period for patients will be 30 days.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Group A "Haemoblock"
100 patients. Haemostatic solution "Haemoblock" will be used after pocket formation during pacemaker implantation.
Pacemaker implantation
Implantation of the pacemaker due to indications in patients with atrioventricular block, sick sinus syndrome, atrial fibrillation with impaired atrioventricular conduction or other.
Haemostatic solution "Haemoblock" application
Haemostatic solution "Haemoblock" will be used after pocket formation during pacemaker implantation.
Ultrasound of pacemaker pocket
Pacemaker pocket ultrasound examination to diagnose pocket hematoma 3-5 days after surgery.
Blood sampling
Blood sampling for Platelet, Prothrombin, Fibrinogen, International Normalized Ratio, Creatinine, Albumin evaluation.
Echocardiography
Heart ultrasound examination for left ventricular ejection fraction measurement.
Group B "Control"
100 patients. Saline solution will be used after pocket formation during pacemaker implantation.
Pacemaker implantation
Implantation of the pacemaker due to indications in patients with atrioventricular block, sick sinus syndrome, atrial fibrillation with impaired atrioventricular conduction or other.
Saline solution application
Saline solution will be used after pocket formation during pacemaker implantation.
Ultrasound of pacemaker pocket
Pacemaker pocket ultrasound examination to diagnose pocket hematoma 3-5 days after surgery.
Blood sampling
Blood sampling for Platelet, Prothrombin, Fibrinogen, International Normalized Ratio, Creatinine, Albumin evaluation.
Echocardiography
Heart ultrasound examination for left ventricular ejection fraction measurement.
Interventions
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Pacemaker implantation
Implantation of the pacemaker due to indications in patients with atrioventricular block, sick sinus syndrome, atrial fibrillation with impaired atrioventricular conduction or other.
Haemostatic solution "Haemoblock" application
Haemostatic solution "Haemoblock" will be used after pocket formation during pacemaker implantation.
Saline solution application
Saline solution will be used after pocket formation during pacemaker implantation.
Ultrasound of pacemaker pocket
Pacemaker pocket ultrasound examination to diagnose pocket hematoma 3-5 days after surgery.
Blood sampling
Blood sampling for Platelet, Prothrombin, Fibrinogen, International Normalized Ratio, Creatinine, Albumin evaluation.
Echocardiography
Heart ultrasound examination for left ventricular ejection fraction measurement.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* men and women aged 40-85 years with indications for pacemaker implantation, taking oral anticoagulants before surgery for at least 7 days;
Exclusion Criteria
* known contraindications for the study haemostatic solution "Haemoblock";
* severe arterial hypertension: Systolic blood pressure ≥ 200 mmHg and/or Diastolic blood pressure ≥ 110 mmHg;
* unstable forms of ischemic heart disease;
* hemostasis disorders in the number of platelets, prothrombin, fibrinogen levels, or International Normalised Ratio above 3.0
* LVEF according to Simpson \<35%;
* the period of pregnancy and lactation;
* chronic renal failure: creatinine clearance less than 40 ml/min;
* hemoglobin level \<90 g/l;
* participation in another study.
40 Years
85 Years
ALL
No
Sponsors
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Ryazan State Medical University
OTHER
Responsible Party
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Principal Investigators
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Igor A. Suchkov, MD, DSc
Role: PRINCIPAL_INVESTIGATOR
Ryazan State Medical University
Locations
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Ryazan State Medical University
Ryazan, Ryazan Oblast, Russia
Countries
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Other Identifiers
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PEGASUS2020
Identifier Type: -
Identifier Source: org_study_id
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