Hematoma PostoperativeNCT04559646
Application of the "Haemoblock" in Pacemaker Patients
An observational study of Hematoma Postoperative, run by Ryazan State Medical University at 1 site in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Hematoma Postoperative
- What is being tested?
- Pacemaker implantation, Haemostatic solution "Haemoblock" application and Saline solution application
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteRussia
- Study dates
- 1 Jan 2021to 1 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 200 patients with indications for pacemaker implantation (atrioventricular block, sick sinus syndrome, atrial fibrillation with impaired atrioventricular conduction or other).
Who may be able to join
- 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;
Who cannot join
- 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%;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hematoma Postoperative
- Being tested
- Pacemaker implantation, Haemostatic solution "Haemoblock" application, Saline solution application, Ultrasound of pacemaker pocket, Blood sampling
- Keywords
- Cardiac implantable electronic devices, Pacing, Pocket hematoma, Haemorrhagic complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacemaker implantationProcedure or surgery
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" applicationDrug
Also called "Haemoblock" application
Haemostatic solution "Haemoblock" will be used after pocket formation during pacemaker implantation.
Saline solution applicationDrug
Also called Saline application
Saline solution will be used after pocket formation during pacemaker implantation.
Ultrasound of pacemaker pocketDiagnostic test
Pacemaker pocket ultrasound examination to diagnose pocket hematoma 3-5 days after surgery.
Blood samplingDiagnostic test
Blood sampling for Platelet, Prothrombin, Fibrinogen, International Normalized Ratio, Creatinine, Albumin evaluation.
EchocardiographyDiagnostic test
Heart ultrasound examination for left ventricular ejection fraction measurement.
| Study group | Role | What they receive |
|---|---|---|
| Group A "Haemoblock" | 100 patients. Haemostatic solution "Haemoblock" will be used after pocket formation during pacemaker implantation. Receives: Procedure: Pacemaker implantation; Drug: Haemostatic solution "Haemoblock" application; Diagnostic Test: Ultrasound of pacemaker pocket; Diagnostic Test: Blood sampling; Diagnostic Test: Echocardiography | |
| Group B "Control" | 100 patients. Saline solution will be used after pocket formation during pacemaker implantation. Receives: Procedure: Pacemaker implantation; Drug: Saline solution application; Diagnostic Test: Ultrasound of pacemaker pocket; Diagnostic Test: Blood sampling; Diagnostic Test: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 30 days after pacemaker implantation.
Secondary outcomes (5)
Drainage installation during surgery.
Installation of a drainage system during pacemaker implantation for draining hematoma after surgery.
Measured: During surgery.
Hematoma drainage duration.
Duration of hematoma drainage after pacemaker implantation if installed during surgery.
Measured: 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.
Measured: Up to 30 days after pacemaker implantation.
Exceeding the average length of hospital stay.
Exceeding the average length (7 days) of hospital stay.
Measured: 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.
Measured: Up to 30 days after pacemaker implantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start1 Jan 2021
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematoma PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ryazan State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Igor A. Suchkov, MD, DSc, Principal investigator, Ryazan State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559646
- Sponsor's protocol ID
- PEGASUS2020
- Status last verified
- Nov 2023
- First submitted
- 16 Sep 2020
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Basic demographic data, including sex, age, and ethnicity are to be shared if allowed by the privacy policy.
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of the Haemostatic Solution "Haemoblock" to Reduce the Risk of Pacemaker Pocket Hematoma
- ClinicalTrials.gov ID
- NCT04559646
- Acronym / sponsor ID
- PEGASUS2020
- Conditions
- Hematoma Postoperative
- Keywords
- Cardiac implantable electronic devices, Pacing, Pocket hematoma, Haemorrhagic complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Ryazan State Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 23 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A "Haemoblock" | – | Procedure: Pacemaker implantation, Drug: Haemostatic solution "Haemoblock" application, Diagnostic Test: Ultrasound of pacemaker pocket, Diagnostic Test: Blood sampling, Diagnostic Test: Echocardiography100 patients. Haemostatic solution "Haemoblock" will be used after pocket formation during pacemaker implantation. |
| Group B "Control" | – | Procedure: Pacemaker implantation, Drug: Saline solution application, Diagnostic Test: Ultrasound of pacemaker pocket, Diagnostic Test: Blood sampling, Diagnostic Test: Echocardiography100 patients. Saline solution will be used after pocket formation during pacemaker implantation. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 200 patients with indications for pacemaker implantation (atrioventricular block, sick sinus syndrome, atrial fibrillation with impaired atrioventricular conduction or other).
Key inclusion criteria (2 listed)
- 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;
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pacemaker implantationImplantation of the pacemaker due to indications in patients with atrioventricular block, sick sinus syndrome, atrial fibrillation with impaired atrioventricular conduction or other. | Procedure or surgery | Group A "Haemoblock", Group B "Control" |
| Haemostatic solution "Haemoblock" applicationAlso: "Haemoblock" applicationHaemostatic solution "Haemoblock" will be used after pocket formation during pacemaker implantation. | Drug | Group A "Haemoblock" |
| Saline solution applicationAlso: Saline applicationSaline solution will be used after pocket formation during pacemaker implantation. | Drug | Group B "Control" |
| Ultrasound of pacemaker pocketPacemaker pocket ultrasound examination to diagnose pocket hematoma 3-5 days after surgery. | Diagnostic test | Group A "Haemoblock", Group B "Control" |
| Blood samplingBlood sampling for Platelet, Prothrombin, Fibrinogen, International Normalized Ratio, Creatinine, Albumin evaluation. | Diagnostic test | Group A "Haemoblock", Group B "Control" |
| EchocardiographyHeart ultrasound examination for left ventricular ejection fraction measurement. | Diagnostic test | Group A "Haemoblock", Group B "Control" |
Primary outcome
The presence of free fluid (blood) in the pacemaker pocket in the early postoperative period, diagnosed by ultrasound.
Time frame: Up to 30 days after pacemaker implantation.
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.
5 secondary outcomes
Drainage installation during surgery.
Time frame: During surgery.
Hematoma drainage duration.
Time frame: Up to 7 days after pacemaker implantation.
Imbibition of soft tissues near pacemaker pocket.
Time frame: Up to 30 days after pacemaker implantation.
Exceeding the average length of hospital stay.
Time frame: Up to 30 days after pacemaker implantation.
Pacemaker implantation complications and cardiac events (stroke, transient ischemic attack, bleeding, pericarditis, cardiac tamponade, infection).
Time frame: Up to 30 days after pacemaker implantation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: Undecided. Basic demographic data, including sex, age, and ethnicity are to be shared if allowed by the privacy policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Igor A. Suchkov, MD, DSc principal investigator
Ryazan State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematoma Postoperative, run by Ryazan State Medical University at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The presence of free fluid (blood) in the pacemaker pocket in the early postoperative period, diagnosed by ultrasound. (time frame: Up to 30 days after pacemaker implantation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.