Patient Blood Management Implementation in CEE Study

NCT06878105 | Recruiting DMC

• 1 other identifier: CG90142103
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anemia; Coagulopathy

Outcome Measures

Primary Outcomes (1)

• Was the PBM training able to significantly reduce the use of blood products in the audited periods?

  Identification of local and country level PBM gaps during the first self audit followed by training and corrective measures, reidentification of remaining local and country level PBM gaps during the second self audit: 1. Reduction of RBC, FFP and TC in Units 2. PBM trained physichian in number

  second self audit versus first self audit ( 6 months)

Secondary Outcomes (5)

• Material assets for the PBM pillars

  second self audit versus first self audit ( 6 months)

• Impact of PBM implementation on postoperative care

  second self audit versus first self audit ( 6 months)

• Impact of PBM implementation on postoperative care

  second self audit versus first self audit ( 9 months)

• PBM implementation impact on infection rates

  second self audit versus first self audit ( 6 months)

• PBM implemetnation impact on mortality

  second self audit versus first self audit ( 6 months)

Study Arms (2)

Hospital self audit data baseline before PBM training

Anticipated 50 hospitals from Hungary, Romania, Czech Republic, Slovakia, Croatia, Austria. Only data about drugs/blood products used as medical routine will be recorded - no evaluation of any drug effect/efficacy.

Other: Data collection on interventions performs as per medical routine

Hospital self audit data after 6 month after PBM training

Anticipated 50 hospitals from Hungary, Romania, Czech Republic, Slovakia, Croatia, Austria.Only data about drugs/blood products used as medical routine will be recorded - no evaluation of any drug effect/efficacy.

Other: Data collection on interventions performs as per medical routine

Interventions

Data collection on interventions performs as per medical routine OTHER

No intervention other than routine medical practice

Hospital self audit data after 6 month after PBM training; Hospital self audit data baseline before PBM training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing elective surgerical interventions with medium or high bleeding risk during predefined two times one week periods - one week at basline and one week after 6 months

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Semmelweis University: lead
• CSL Behring: collaborator

Study Sites (1)

Semmelweis University

Budapest, 1085, Hungary

RECRUITING

Related Publications (11)

• 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 Collaborators. German Patient Blood Management Network: effectiveness and safety analysis in 1.2 million patients. Br J Anaesth. 2023 Sep;131(3):472-481. doi: 10.1016/j.bja.2023.05.006. Epub 2023 Jun 26.

  PMID: 37380568 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Kietaibl S, Ahmed A, Afshari A, Albaladejo P, Aldecoa C, Barauskas G, De Robertis E, Faraoni D, Filipescu DC, Fries D, Godier A, Haas T, Jacob M, Lance MD, Llau JV, Meier J, Molnar Z, Mora L, Rahe-Meyer N, Samama CM, Scarlatescu E, Schlimp C, Wikkelso AJ, Zacharowski K. Management of severe peri-operative bleeding: Guidelines from the European Society of Anaesthesiology and Intensive Care: Second update 2022. Eur J Anaesthesiol. 2023 Apr 1;40(4):226-304. doi: 10.1097/EJA.0000000000001803.

  PMID: 36855941 BACKGROUND

• Musallam KM, Tamim HM, Richards T, Spahn DR, Rosendaal FR, Habbal A, Khreiss M, Dahdaleh FS, Khavandi K, Sfeir PM, Soweid A, Hoballah JJ, Taher AT, Jamali FR. Preoperative anaemia and postoperative outcomes in non-cardiac surgery: a retrospective cohort study. Lancet. 2011 Oct 15;378(9800):1396-407. doi: 10.1016/S0140-6736(11)61381-0. Epub 2011 Oct 5.

  PMID: 21982521 BACKGROUND

• Yan T, Lei S, Zhou B, Huang Y, Li X, Zhang J, Huang Q, Zhang L. Association between preoperative anemia and postoperative short-term outcomes in patients undergoing colorectal cancer surgery - a propensity score matched retrospective cohort study. BMC Anesthesiol. 2023 Sep 11;23(1):307. doi: 10.1186/s12871-023-02270-2.

  PMID: 37697231 BACKGROUND

• 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 BACKGROUND

Related Links

• WHO PBM policy
• EU Publication office: practical PBM implementation guide for hospitals
• Information about PBM

MeSH Terms

Conditions

Anemia; Hemostatic Disorders

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders

Central Study Contacts

János Fazakas, Ass Prof

CONTACT

+36208258560; jancsidora@gmail.com

Anikó Smudla, MD

CONTACT

+36304362384; aniko_smudla@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 2, 2024
• First Posted: March 14, 2025
• Study Start: May 27, 2024
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Locations

HU (1)