Application of the "Haemoblock" in Pacemaker Patients
Condition: Hematoma Postoperative
MeSH terms: Hematoma
Study type: Observational

Summary: 
      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: 
      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.
    

Intervention name(s): Pacemaker implantation; Haemostatic solution "Haemoblock" application; Saline solution application; Ultrasound of pacemaker pocket; Blood sampling; Echocardiography
Intervention type(s): Procedure; Drug; Drug; Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): 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" will be used after pocket formation during pacemaker implantation.; Saline solution will be used after pocket formation during pacemaker implantation.; Pacemaker pocket ultrasound examination to diagnose pocket hematoma 3-5 days after surgery.; Blood sampling for Platelet, Prothrombin, Fibrinogen, International Normalized Ratio, Creatinine, Albumin evaluation.; Heart ultrasound examination for left ventricular ejection fraction measurement.
Other intervention name(s): "Haemoblock" application; Saline application
Intervention MeSH terms: Hemostatics; Pharmaceutical Solutions
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        200 patients with indications for pacemaker implantation (atrioventricular block, sick
        sinus syndrome, atrial fibrillation with impaired atrioventricular conduction or other).
      
Keywords: Cardiac implantable electronic devices; Pacing; Pocket hematoma; Haemorrhagic complications