NCT02147795

Brief Summary

  • This epidemiological trial will determine whether the implementation of a PBM program is safe and effective in terms of clinical outcome compared to a pre-implementation cohort
  • Primary endpoint is a composite outcome comprising in-hospital myocardial infarction, stroke, acute renal failure, death of any cause, pneumonia and sepsis until discharge from hospital in patients before and after implementation of the PBM program.
  • Secondary endpoints are the length of stay on the intensive care unit, total hospital stay and the quantitative utilization of allogeneic RBC units, platelet concentrates, other blood products (e.g. fresh frozen (therapeutic) plasma), coagulations factors, and cell saver systems during hospital stay.
  • The primary aim is to prove non-inferiority of the intervention (PBM) group when compared with the control group stratified by center.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 13, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 28, 2014

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 10, 2023

Status Verified

March 1, 2023

Enrollment Period

12.9 years

First QC Date

May 13, 2014

Last Update Submit

March 8, 2023

Conditions

Clinical Safety of a PBM Program

Keywords

Patient Blood ManagementRed Blood Cell Transfusion PracticePatient SafetyAnemiaClinical Outcomeperioperative care

Outcome Measures

Primary Outcomes (1)

  • Composite Outcome for and after PBM program

    composite outcome comprising in-hospital myocardial infarction, stroke, acute renal failure, death of any cause, pneumonia and sepsis until discharge from hospital in patients before and after implementation of the PBM program

    Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Secondary Outcomes (2)

  • Length of stay

    Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

  • haemotherapy

    Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Study Arms (2)

Control cohort

Standard care before implementation (pre-implementation)

PBM cohort

After implementation of PBM program (post-implementation)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adult surgical patients

You may qualify if:

  • all surgeries with a general or local anaesthetic
  • minimum hospital stay of 24 h
  • ≥ 18 years

You may not qualify if:

  • \< 18 years
  • ophthalmologic or dermatologic or outpatient surgery
  • all non-surgical anesthetic procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Goethe University Hospital

Frankfurt am Main, Hesse, 60590, Germany

RECRUITING

University Hospital Würzburg

Würzburg, Germany

RECRUITING

Related Publications (2)

  • 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: 37380568DERIVED

  • Schmitt E, Meybohm P, Neef V, Baumgarten P, Bayer A, Choorapoikayil S, Friederich P, Friedrich J, Geisen C, Guresir E, Grunewald M, Gutjahr M, Helmer P, Herrmann E, Muller M, Narita D, Raadts A, Schwendner K, Seifried E, Stark P, Steinbicker AU, Thoma J, Velten M, Weigt H, Wiesenack C, Wittmann M, Zacharowski K, Piekarski F; German PBM Network Collaborators. Preoperative anaemia and red blood cell transfusion in patients with aneurysmal subarachnoid and intracerebral haemorrhage - a multicentre subanalysis of the German PBM Network Registry. Acta Neurochir (Wien). 2022 Apr;164(4):985-999. doi: 10.1007/s00701-022-05144-7. Epub 2022 Feb 26.

    PMID: 35220460DERIVED

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Kai D Zacharowski, Prof, MD, PhD

CONTACT

0049 69 6301Direktion.Anaesthesie@kgu.de

Patrick Meybohm, M.D

CONTACT

0049 6906301patientbloodmanagement@kgu.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Kai Zacharowski, M.D., Ph.D., FRCA

Study Record Dates

First Submitted

May 13, 2014

First Posted

May 28, 2014

Study Start

January 1, 2012

Primary Completion

December 1, 2024

Study Completion

December 1, 2025

Last Updated

March 10, 2023

Record last verified: 2023-03

Locations

DE(2)