NCT04559646

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 23, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

2.8 years

First QC Date

September 16, 2020

Last Update Submit

November 15, 2023

Conditions

Hematoma Postoperative

Keywords

Cardiac implantable electronic devicesPacingPocket hematomaHaemorrhagic complications

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Drainage installation during surgery.

    During surgery.

  • Hematoma drainage duration.

    Up to 7 days after pacemaker implantation.

  • Imbibition of soft tissues near pacemaker pocket.

    Up to 30 days after pacemaker implantation.

  • Exceeding the average length 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).

    Up to 30 days after pacemaker implantation.

Study Arms (2)

Group A "Haemoblock"

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

Procedure: Pacemaker implantationDrug: Haemostatic solution "Haemoblock" applicationDiagnostic Test: Ultrasound of pacemaker pocketDiagnostic Test: Blood samplingDiagnostic Test: Echocardiography

Group B "Control"

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

Procedure: Pacemaker implantationDrug: Saline solution applicationDiagnostic Test: Ultrasound of pacemaker pocketDiagnostic Test: Blood samplingDiagnostic Test: Echocardiography

Interventions

Pacemaker implantationPROCEDURE

Implantation of the pacemaker due to indications in patients with atrioventricular block, sick sinus syndrome, atrial fibrillation with impaired atrioventricular conduction or other.

Group A "Haemoblock"Group B "Control"
Haemostatic solution "Haemoblock" applicationDRUG

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

Also known as: "Haemoblock" application
Group A "Haemoblock"
Saline solution applicationDRUG

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

Also known as: Saline application
Group B "Control"
Ultrasound of pacemaker pocketDIAGNOSTIC_TEST

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

Group A "Haemoblock"Group B "Control"
Blood samplingDIAGNOSTIC_TEST

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

Group A "Haemoblock"Group B "Control"
EchocardiographyDIAGNOSTIC_TEST

Heart ultrasound examination for left ventricular ejection fraction measurement.

Group A "Haemoblock"Group B "Control"

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

200 patients with indications for pacemaker implantation (atrioventricular block, sick sinus syndrome, atrial fibrillation with impaired atrioventricular conduction or other).

You may qualify if:

  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ryazan State Medical University

Ryazan, Ryazan Oblast, Russia

Location

MeSH Terms

Interventions

Blood Specimen CollectionEchocardiography

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative TechniquesCardiac Imaging TechniquesDiagnostic ImagingUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Igor A. Suchkov, MD, DSc

    Ryazan State Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2020

First Posted

September 23, 2020

Study Start

January 1, 2021

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

November 18, 2023

Record last verified: 2023-11

Locations

RU(1)