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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.
А multicenter research trial will be conducted at 6 medical centers:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A "Haemoblock" | 100 patients. Haemostatic solution "Haemoblock" will be used after pocket formation during pacemaker implantation. |
| |
| Group B "Control" | 100 patients. Saline solution will be used after pocket formation during pacemaker implantation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pacemaker implantation | Procedure | Implantation of the pacemaker due to indications in patients with atrioventricular block, sick sinus syndrome, atrial fibrillation with impaired atrioventricular conduction or other. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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200 patients with indications for pacemaker implantation (atrioventricular block, sick sinus syndrome, atrial fibrillation with impaired atrioventricular conduction or other).
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| Name | Affiliation | Role |
|---|---|---|
| Igor A. Suchkov, MD, DSc | Ryazan State Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ryazan State Medical University | Ryazan | Ryazan Oblast | Russia |
Basic demographic data, including sex, age, and ethnicity are to be shared if allowed by the privacy policy.
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D004452 | Echocardiography |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Haemostatic solution "Haemoblock" application | Drug | Haemostatic solution "Haemoblock" will be used after pocket formation during pacemaker implantation. |
|
|
| Saline solution application | Drug | Saline solution will be used after pocket formation during pacemaker implantation. |
|
|
| Ultrasound of pacemaker pocket | Diagnostic Test | Pacemaker pocket ultrasound examination to diagnose pocket hematoma 3-5 days after surgery. |
|
| Blood sampling | Diagnostic Test | Blood sampling for Platelet, Prothrombin, Fibrinogen, International Normalized Ratio, Creatinine, Albumin evaluation. |
|
| Echocardiography | Diagnostic Test | Heart ultrasound examination for left ventricular ejection fraction measurement. |
|
| 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. |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D057791 | Cardiac Imaging Techniques |
| D003952 | Diagnostic Imaging |
| D014463 | Ultrasonography |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |