Application of the "Haemoblock" in Pacemaker Patients

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.

Conditions

• Hematoma Postoperative

Interventions

PROCEDURE

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.

DRUG

Haemostatic solution "Haemoblock" application

Haemostatic solution "Haemoblock" will be used after pocket formation during pacemaker implantation.

DRUG

Saline solution application

Saline solution will be used after pocket formation during pacemaker implantation.

DIAGNOSTIC_TEST

Ultrasound of pacemaker pocket

Pacemaker pocket ultrasound examination to diagnose pocket hematoma 3-5 days after surgery.

DIAGNOSTIC_TEST

Blood sampling

Blood sampling for Platelet, Prothrombin, Fibrinogen, International Normalized Ratio, Creatinine, Albumin evaluation.

DIAGNOSTIC_TEST

Echocardiography

Heart ultrasound examination for left ventricular ejection fraction measurement.

Sponsors & Collaborators

• Ryazan State Medical University

  lead OTHER

Principal Investigators

• Igor A. Suchkov, MD, DSc · Ryazan State Medical University

Eligibility

Min Age

40 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-01

Primary Completion

2023-11-01

Completion

2023-11-01

Countries

• Russia

Study Locations