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| Name | Class |
|---|---|
| CSL Behring | INDUSTRY |
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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.
The goals of the PBM program:
Improving patient care and optimizing blood management - quality assurance
bleeding management based on latest scientific guidelines including:
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):
Patient level data:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data collection on interventions performs as per medical routine | Other | No intervention other than routine medical practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| second self audit versus first self audit ( 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Material assets for the PBM pillars |
| second self audit versus first self audit ( 6 months) |
| Impact of PBM implementation on postoperative care |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| János Fazakas, Ass Prof | Contact | +36208258560 | jancsidora@gmail.com | |
| Anikó Smudla, MD | Contact | +36304362384 | aniko_smudla@yahoo.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Semmelweis University | Recruiting | Budapest | 1085 | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38314244 | 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. | |
| 37380568 |
| Label | URL |
|---|---|
| WHO PBM policy | View source |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D020141 | Hemostatic Disorders |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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Time spent in the intensive care unit in the postoperative period (ICU days) |
| second self audit versus first self audit ( 6 months) |
| Impact of PBM implementation on postoperative care | Hospital length of stay (days) | second self audit versus first self audit ( 9 months) |
| PBM implementation impact on infection rates | Postoperative infection rate | second self audit versus first self audit ( 6 months) |
| PBM implemetnation impact on mortality | 30 days mortality | second self audit versus first self audit ( 6 months) |
| Result |
| 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. |
| 38282333 | Result | 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. |
| 32894734 | Result | 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. |
| 32894735 | Result | 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. |
| 33293819 | Result | 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. |
| 23590915 | Result | 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. |
| 34215251 | Result | 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. |
| 36855941 | Result | 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. |
| 21982521 | Result | 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. |
| 37697231 | Result | 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. |
| EU Publication office: practical PBM implementation guide for hospitals | View source |
| Information about PBM | View source |
| D006474 | Hemorrhagic Disorders |