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临床试验/NCT04559646
NCT04559646已完成不适用

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

Ryazan State Medical University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
200
试验地点
1
主要终点
The presence of free fluid (blood) in the pacemaker pocket in the early postoperative period, diagnosed by ultrasound.

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
40 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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;

排除标准

  • 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.

研究组 & 干预措施

Group A "Haemoblock"

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

干预措施: Pacemaker implantation (Procedure)

Group A "Haemoblock"

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

干预措施: Haemostatic solution "Haemoblock" application (Drug)

Group A "Haemoblock"

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

干预措施: Ultrasound of pacemaker pocket (Diagnostic Test)

Group A "Haemoblock"

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

干预措施: Blood sampling (Diagnostic Test)

Group A "Haemoblock"

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

干预措施: Echocardiography (Diagnostic Test)

Group B "Control"

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

干预措施: Pacemaker implantation (Procedure)

Group B "Control"

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

干预措施: Saline solution application (Drug)

Group B "Control"

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

干预措施: Ultrasound of pacemaker pocket (Diagnostic Test)

Group B "Control"

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

干预措施: Blood sampling (Diagnostic Test)

Group B "Control"

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

干预措施: Echocardiography (Diagnostic Test)

结局指标

主要结局

The presence of free fluid (blood) in the pacemaker pocket in the early postoperative period, diagnosed by ultrasound.

时间窗: 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.

次要结局

  • 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.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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