Patient Blood Management Implementation in CEE Study

Официальное название

Evaluation of Fixed and Personal Assets for Patient Blood Management Implementation in CEE Countries in Practice

Обзор

The goal of the study is data collection on available fixed and personal assets required for Patient Blood Management (elements of the 3 pillars of PBM) in Central Eastern Europe countries hospitals, status before and after PBM training.

Подробное описание

The goals of the PBM program:

* Improving patient care and optimizing blood management - quality assurance * bleeding management based on latest scientific guidelines including:

1. reduction of transfusion and better outcomes 2. optimization of blood reserves 3. introduction and acceptance of hospital protocols Previous research has identified gaps concerning implementation of PBM elements in CEE region calling for further research and training: anemia is not being managed appropriately, there are no protocols in place, patient journey is not clearly defined, it is not clear at which department should be anemia treated; availability of POC devices varies largely among countries; local protocols for management of severe bleeding are also missing in many hospitals.

Investigators plan to collect PBM implementation indicators in hospitals before PBM training at a given start point as baseline (first self audit) and re-evaluate achievements after 6 months after training (second self audit).

Investigators plan to define 2x1 week "snapshot" period for detailed analysis of perioperative approach at patient level (1 week at the beginning of the study and 1 week after 6 month).

Investigators assume that properly conducted self-audits followed by PBM training, optimizing local protocols and patient journeys, a reduction in the use of perioperative blood products may be achieved, which, in addition to the currently experienced decrease in the desire to donate blood, may lead to a more rational blood product management and better patient outcomes.

PBM Implementation indicators for hospitals (data to be collected):

* PBM administration \& training data - are there PBM managers/local protocols available? was there any PBM training of staff performed? * Pilar I.: data about diagnosis and management of anemia; patient pathways; medications used to treat anemia * Pilar II.: blood saving techniques; usage of blood products (transfusion) and/or factor concentrates; iatrogenic blood loss - lab test tubes size * Pilar III.: RBC tranfusion triggers;

Patient level data:

* age, gender, type of surgical intervention * data about anemia management (performed or not by whom, when and what treatment was received if any * data about existing anticoagulant therapy an management * data about bleeding management (blood loss, transfusion requirements, factor concentrates (used quantities per routine medical intervention), POC tests evaluations if any, and standard laboratory test performed per routine medical approach before, during and after surgery * data about postoperative outcomes

Вмешательства

• Другое Data collection on interventions performs as per medical routine
  No intervention other than routine medical practice

Первичные конечные точки

• Was the PBM training able to significantly reduce the use of blood products in the audited periods? [Срок оценки: second self audit versus first self audit ( 6 months)]

Вторичные конечные точки (5)

• Material assets for the PBM pillars [Срок оценки: second self audit versus first self audit ( 6 months)]
• Impact of PBM implementation on postoperative care [Срок оценки: second self audit versus first self audit ( 6 months)]
• Impact of PBM implementation on postoperative care [Срок оценки: second self audit versus first self audit ( 9 months)]
• PBM implementation impact on infection rates [Срок оценки: second self audit versus first self audit ( 6 months)]
• PBM implemetnation impact on mortality [Срок оценки: second self audit versus first self audit ( 6 months)]

Критерии участия

Критерии включения

• patients above 18 years of age
• patients undergoing elective medium and high bleeding risk surgical intervention defined as moderate (<500 ml) and high (≥ 500 ml)
• patient consent

Критерии исключения

• no patient consent
• patients under 18 years of age
• pregnant patients
• surgery with a low risk of bleeding
• the patient underwent emergency (non-elective) surgery

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

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Венгрия · 1 центр

• Semmelweis University — Budapest

Публикации

• Uden H, Buttner F, von Heymann C, Kramer M, Kaufner L, Vorderwulbecke G, Hardt S, Kruppa J, Balzer F, Spies C. Allogeneic Blood Transfusion and Risk of Postoperative Complications in Patients with Mild and Moderate Anemia of Any Cause? A Retrospective Cohort Study in Total Revision Hip Surgery. Transfus Med Hemother. 2023 Jul 12;51(1):12-21. doi: 10.1159/000530135. eCollection 2024 Feb. PMID 38314244
• Meybohm P, Schmitt E, Choorapoikayil S, Hof L, Old O, Muller MM, Geisen C, Seifried E, Baumhove O, de Leeuw van Weenen S, Bayer A, Friederich P, Brautigam B, Friedrich J, Gruenewald M, Elke G, Molter GP, Narita D, Raadts A, Haas C, Schwendner K, Steinbicker AU, Jenke DJ, Thoma J, Weber V, Velten M, Wittmann M, Weigt H, Lange B, Herrmann E, Zacharowski K; German Patient Blood Management Network Col PMID 37380568
• Mitra B, Jorgensen M, Reade MC, Keegan A, Holley A, Farmer S, Harvey N, Winearls J, Parr M, French CJ; Clinical and Consumer Reference group for the update of Patient Blood Management Guidelines (Module 1: Critical Bleeding/Massive Transfusion). Patient blood management guideline for adults with critical bleeding. Med J Aust. 2024 Mar 4;220(4):211-216. doi: 10.5694/mja2.52212. Epub 2024 Jan 28. PMID 38282333
• Babik B, Fazakas J, Matusovits A, Gal J, Fulesdi B. [Perioperative Patient Blood Management: common risk, common tasks, common responsibility]. Orv Hetil. 2020 Sep;161(37):1545-1553. doi: 10.1556/650.2020.31918. Hungarian. PMID 32894734
• Olah Z, Fulesdi B, Gal J, Matusovits A, Babik B. [Principles of the perioperative Patient Blood Management]. Orv Hetil. 2020 Sep;161(37):1554-1568. doi: 10.1556/650.2020.31787. Hungarian. PMID 32894735
• Delaforce A, Duff J, Munday J, Hardy J. Preoperative Anemia and Iron Deficiency Screening, Evaluation and Management: Barrier Identification and Implementation Strategy Mapping. J Multidiscip Healthc. 2020 Dec 1;13:1759-1770. doi: 10.2147/JMDH.S282308. eCollection 2020. PMID 33293819
• Farmer SL, Towler SC, Leahy MF, Hofmann A. Drivers for change: Western Australia Patient Blood Management Program (WA PBMP), World Health Assembly (WHA) and Advisory Committee on Blood Safety and Availability (ACBSA). Best Pract Res Clin Anaesthesiol. 2013 Mar;27(1):43-58. doi: 10.1016/j.bpa.2012.12.007. PMID 23590915
• Hofmann A, Spahn DR, Holtorf AP; PBM Implementation Group. Making patient blood management the new norm(al) as experienced by implementors in diverse countries. BMC Health Serv Res. 2021 Jul 2;21(1):634. doi: 10.1186/s12913-021-06484-3. PMID 34215251

Идентификаторы

NCT: NCT06878105 · CG90142103

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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