Application of the "Haemoblock" in Pacemaker Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Hematoma Postoperative
• Intervention / Treatment: Procedure: Pacemaker implantation; Drug: Haemostatic solution "Haemoblock" application; Diagnostic test: Ultrasound of pacemaker pocket; Diagnostic test: Blood sampling; Diagnostic test: Echocardiography; Drug: Saline solution application

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.

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

• Study Contact: Name: Vladislav O. Povarov, MD, PhD; Phone Number: +7-915-602-74-78; Email: povarov.vladislav@mail.ru

Study Locations

• Russian Federation
  • Ryazan
    • Ryazan', Ryazan, Russian Federation
      • Ryazan State Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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).

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A "Haemoblock"; 100 patients. Haemostatic solution "Haemoblock" will be used after pocket formation during pacemaker implantation.	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.; Other Names: "Haemoblock" application; 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.
Group B "Control"; 100 patients. Saline solution will be used after pocket formation during pacemaker implantation.	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.; 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.; Drug: Saline solution application; Saline solution will be used after pocket formation during pacemaker implantation.; Other Names: Saline application

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Ryazan State Medical University
• Investigators: Principal Investigator: Igor A. Suchkov, MD, DSc, Ryazan State Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): November 1, 2023
• Study Completion (Actual): November 1, 2023

Study Registration Dates

• First Submitted: September 16, 2020
• First Submitted That Met QC Criteria: September 16, 2020
• First Posted (Actual): September 23, 2020

Study Record Updates

• Last Update Posted (Estimated): November 16, 2023
• Last Update Submitted That Met QC Criteria: November 15, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Pacing; Cardiac implantable electronic devices; Pocket hematoma; Haemorrhagic complications
• Additional Relevant MeSH Terms: Pathologic Processes; Hemorrhage; Hematoma; Coagulants; Hemostatics; Pharmaceutical Solutions
• Other Study ID Numbers: PEGASUS2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Basic demographic data, including sex, age, and ethnicity are to be shared if allowed by the privacy policy.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No