Application of the Haemoblock in Pacemaker Patients

Study Overview
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Brief Summary
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Pocket hematoma is a known complication of pacemaker (PM) implantation. Pocket hematoma is accompanied by a local discomfort associated with the infiltration of subcutaneous tissue. In some cases, this complication requires repeated surgical revisions, which increases the risk of infection, and increases the duration of a hospital stay. The search for ways to prevent bleeding from the PM pocket is of great practical interest. This question is especially acute in relation to patients who are constantly on anticoagulation and/or antiplatelet therapy. A number of authors propose to carry out complete or partial cancellation of these drugs for the period before surgery and in the early postoperative period. In our opinion, this approach in most cases carries a potential risk to the health of patients, especially in the case of patients who have previously undergone surgical correction of valve insufficiency and/or who have undergone percutaneous endovascular interventions. 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.

Detailed Description
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А multicenter research trial will be conducted at 6 medical centers: 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.

Official Title
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Application of the Haemostatic Solution Haemoblock to Reduce the Risk of Pacemaker Pocket Hematoma

Conditions
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Hematoma Postoperative

Intervention / Treatment
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* Procedure: Pacemaker implantation
* Drug: Haemostatic solution Haemoblock application
* Drug: Saline solution application
* Diagnostic Test: Ultrasound of pacemaker pocket
* Diagnostic Test: Blood sampling
* Diagnostic Test: Echocardiography


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: availability of informed consent of the patient to participate in the study; men and women aged 40-85 years with indications for pacemaker implantation, taking oral anticoagulants before surgery for at least 7 days; Exclusion Criteria: hypoalbuminemia; 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A Haemoblock<br>100 patients. Haemostatic solution Haemoblock will be used after pocket formation during pacemaker implantation. | Procedure: Pacemaker implantation<br>* Implantation of the pacemaker due to indications in patients with atrioventricular block, sick sinus syndrome, atrial fibrillation with impaired atrioventricular conduction or other.<br>Drug: Haemostatic solution Haemoblock application<br>* Haemostatic solution Haemoblock will be used after pocket formation during pacemaker implantation.<br>* Other names: Haemoblock application;Diagnostic Test: Ultrasound of pacemaker pocket<br>* Pacemaker pocket ultrasound examination to diagnose pocket hematoma 3-5 days after surgery.<br>Diagnostic Test: Blood sampling<br>* Blood sampling for Platelet, Prothrombin, Fibrinogen, International Normalized Ratio, Creatinine, Albumin evaluation.<br>Diagnostic Test: Echocardiography<br>* Heart ultrasound examination for left ventricular ejection fraction measurement.<br>|
| Group B Control<br>100 patients. Saline solution will be used after pocket formation during pacemaker implantation. | Procedure: Pacemaker implantation<br>* Implantation of the pacemaker due to indications in patients with atrioventricular block, sick sinus syndrome, atrial fibrillation with impaired atrioventricular conduction or other.<br>Drug: Saline solution application<br>* Saline solution will be used after pocket formation during pacemaker implantation.<br>* Other names: Saline application;Diagnostic Test: Ultrasound of pacemaker pocket<br>* Pacemaker pocket ultrasound examination to diagnose pocket hematoma 3-5 days after surgery.<br>Diagnostic Test: Blood sampling<br>* Blood sampling for Platelet, Prothrombin, Fibrinogen, International Normalized Ratio, Creatinine, Albumin evaluation.<br>Diagnostic Test: Echocardiography<br>* Heart ultrasound examination for left ventricular ejection fraction measurement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The presence of free fluid (blood) in the pacemaker pocket in the early postoperative period, diagnosed by ultrasound. | Ultrasound of pacemaker pocket to diagnose pocket hematoma will be performed in all patients. The presence of a hematoma (fluid) in the pacemaker pocket before the ultrasound can be verified after examination by the surgeon by the detection of palpable infiltration, smoothing the pacemaker contour, the presence of a fluctuation effect. | Up to 30 days after pacemaker implantation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drainage installation during surgery. | Installation of a drainage system during pacemaker implantation for draining hematoma after surgery. | During surgery. | 
| Hematoma drainage duration. | Duration of hematoma drainage after pacemaker implantation if installed during surgery. | Up to 7 days after pacemaker implantation. | 
| Imbibition of soft tissues near pacemaker pocket. | Imbibition of soft tissues around pacemaker pocket detected on physical examination. | Up to 30 days after pacemaker implantation. | 
| Exceeding the average length of hospital stay. | Exceeding the average length (7 days) of hospital stay. | Up to 30 days after pacemaker implantation. | 
| Pacemaker implantation complications and cardiac events (stroke, transient ischemic attack, bleeding, pericarditis, cardiac tamponade, infection). | Pacemaker implantation complications and cardiac events (stroke, transient ischemic attack, bleeding, pericarditis, cardiac tamponade, infection) development during observation period. | Up to 30 days after pacemaker implantation. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac implantable electronic devices, Pacing, Pocket hematoma, Haemorrhagic complications