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Идёт набор NCT06511778

sTErnAl heMostasiS Trial

Фаза IV С лечением Excessive Bleeding During Surgery

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Hemoblast Bellows application.
Кому может быть актуально
Состояния в реестре: Excessive Bleeding During Surgery. Базовые параметры: от 21 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

sTErnAl heMostasiS Trial (TEAMS Trial)

Обзор

Sternal bleeding remains an unsolved problem for cardiac surgery teams costing operative time, blood loss, and distraction from the critical operative field. As such, the following is an investigator-initiated trial to determine whether application of a topical hemostatic agent reduces sternal bleeding during cardiac surgery using sternotomy approach.

Подробное описание

This is a prospective randomized 1:1 trial to evaluate the efficacy of the application of HEMOBLASTTM during cardiothoracic surgery to reduce the increased risk of sternal bleeding in 30 treatment and 30 control patients.

Enrollment will be open to all eligible participants undergoing cardiothoracic surgery who sign an informed consent.

The study will also collect demographic data and relevant clinical data, such as medical history, diagnosis, family history, laboratory data, radiological images and reports, and diagnostic procedure reports.

All enrolled subjects will be followed during their hospitalization until discharge for bleeding complications after their surgical procedure as well as a sternal bleeding SPOT GRADE TM score will be recorded independently by both the cardiac surgeon and assisting cardiothoracic PA-C, before and after the application of the topical hemostatic agent. There will be no restriction on the use of electrocautery or vancomycin paste as existing routine adjuncts used in cardiothoracic surgery for sternal hemostasis. Chest tube output measurements will be collected at 6, 12, and 24 hours postoperatively. The patients will be assessed at the time of hospital discharge for any complications related to sternal or intrathoracic bleeding.

Вмешательства

  • Препарат Hemoblast Bellows application
    Hemoblast bellows is a hemostatic agent clinically proven effective on the validated SPOT GRADE scale for minimal, mild, and moderate bleeding. Patients will have the Hemoblast bellows applied during on pump sternotomy surgery.

Первичные конечные точки

  • Sternal Bleeding Score [Срок оценки: Sternotomy creation]
  • Sternal Bleeding Score [Срок оценки: Sternal closure]
  • Reoperation for Bleeding [Срок оценки: Through hospitalization, average of 6 days]
  • Chest Tube Output [Срок оценки: 6 hours postoperatively]
Вторичные конечные точки (1)
  • Chest Tube Output [Срок оценки: 12 and 24 hours postoperatively]

Критерии участия

Критерии включения

  • Patients are scheduled to undergo on-pump open chest cardiothoracic surgery.
  • Patients must be willing and able to provide written informed consent.
  • If the patient is of childbearing potential, they must have a negative pregnancy test within 24 hours of the index procedure.
  • Patients must be at least 21 years of age.
  • Patients have at least one of the following risk factors:
  • Undergoing redo sternotomy
  • Have a preoperative platelet count <150 mg/dL
  • Are on dual antiplatelet therapy (blood thinners) < 5 days prior to sternotomy
  • Have a BMI (body mass index)> 35
  • Are undergoing combined CABG (coronary artery bypass surgery)/valve surgery
  • Have chronic kidney disease (GFR <60 ml/min) or ESRD (end stage renal disease)

Критерии исключения

  • Patients who undergo thoracotomy approach
  • Patients who are not deemed an appropriate candidate by the investigator.
  • Patients who are pregnant or nursing, or who plan to become pregnant during the course of this study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Простое слепое
Основная цель
Профилактика

Центры проведения

США · 1 центр
  • WakeMed Health and Hospitals — Raleigh

Публикации

  • HEMOBLAST™ Bellows Hemostatic Agent [instructions for use]. Dilon Technologies, Inc.
  • Now That's Real Stopping Powder [Information Brochure]. Dilon Technologies, Inc.
  • Spotnitz WD, Zielske D, Centis V, Hoffman R, Gillen DL, Wittmann C, Guyot V, Campos DM, Forest P, Pearson A, McAfee PC. The SPOT GRADE: A New Method for Reproducibly Quantifying Surgical Wound Bleeding. Spine (Phila Pa 1976). 2018 Jun 1;43(11):E664-E671. doi: 10.1097/BRS.0000000000002447. PMID 29019803
  • Elassal AA, Al-Ebrahim KE, Debis RS, Ragab ES, Faden MS, Fatani MA, Allam AR, Abdulla AH, Bukhary AM, Noaman NA, Eldib OS. Re-exploration for bleeding after cardiac surgery: revaluation of urgency and factors promoting low rate. J Cardiothorac Surg. 2021 Jun 7;16(1):166. doi: 10.1186/s13019-021-01545-4. PMID 34099003

Идентификаторы

NCT: NCT06511778 · TEAMS

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗