NCT01820949

Brief Summary

This study will evaluate clinical outcome after the step-wise implementation of a Patient Blood Management (PBM) Program in surgical patients at 4 hospitals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

Geographic Reach
1 country

4 active sites

Status
completed

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, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 19, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 29, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 7, 2015

Status Verified

September 1, 2015

Enrollment Period

2.5 years

First QC Date

March 19, 2013

Last Update Submit

September 4, 2015

Conditions

Surgery

Keywords

patient blood managementpatients safety

Outcome Measures

Primary Outcomes (1)

  • Myocardial infarction, stroke, acute renal failure, death of any cause, pneumonia and sepsisComposite outcome

    Composite endpoint defined as in-hospital myocardial infarction, stroke, acute renal failure, death of any cause, pneumonia and sepsis until discharge from hospital

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

Secondary Outcomes (4)

  • Length of stay on the intensive care unit

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

  • Total hospital stay

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

  • Total number of red blood cell transfusions during hospital stay

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

  • Consumption of coagulation factors

    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 VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all surgical patients over a period of 24 months at 4 hospitals

You may qualify if:

  • All non- ambulant, surgical, anesthetized patients (≥18 years)
  • General Surgery, Cardiac Surgery, Thoracic Surgery, Trauma Surgery, Vascular Surgery, Urology, Gynecology, Otolaryngology, Neurosurgery, Crania-Maxillofacial Surgery

You may not qualify if:

  • ambulant and all non-surgical anesthetic procedures
  • Surgery in the field of Dermatology or Ophthalmology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University Hospital Bonn

Bonn, Germany

Location

University Hospital Frankfurt

Frankfurt, Germany

Location

University Hospital Schleswig-Holstein

Kiel, Germany

Location

University Hospital Muenster

Münster, Germany

Location

Related Publications (3)

  • Ellermann I, Bueckmann A, Eveslage M, Buddendick H, Latal T, Niehoff D, Geissler RG, Hempel G, Kerkhoff A, Berdel WE, Roeder N, Van Aken HK, Zarbock A, Steinbicker AU. Treating Anemia in the Preanesthesia Assessment Clinic: Results of a Retrospective Evaluation. Anesth Analg. 2018 Nov;127(5):1202-1210. doi: 10.1213/ANE.0000000000003583.

    PMID: 29944518DERIVED

  • Meybohm P, Herrmann E, Steinbicker AU, Wittmann M, Gruenewald M, Fischer D, Baumgarten G, Renner J, Van Aken HK, Weber CF, Mueller MM, Geisen C, Rey J, Bon D, Hintereder G, Choorapoikayil S, Oldenburg J, Brockmann C, Geissler RG, Seifried E, Zacharowski K; PBM-study Collaborators. Patient Blood Management is Associated With a Substantial Reduction of Red Blood Cell Utilization and Safe for Patient's Outcome: A Prospective, Multicenter Cohort Study With a Noninferiority Design. Ann Surg. 2016 Aug;264(2):203-11. doi: 10.1097/SLA.0000000000001747.

    PMID: 27163948DERIVED

  • Meybohm P, Fischer DP, Geisen C, Muller MM, Weber CF, Herrmann E, Steffen B, Seifried E, Zacharowski K; German PBM Study Core Group. Safety and effectiveness of a Patient Blood Management (PBM) program in surgical patients--the study design for a multi-centre prospective epidemiologic non-inferiority trial. BMC Health Serv Res. 2014 Nov 19;14:576. doi: 10.1186/s12913-014-0576-3.

    PMID: 25927460DERIVED

Related Links

Study Officials

  • Kai Zacharowski, MD, PhD, FRCA

    Goethe University

    STUDY CHAIR

  • Patrick Meybohm, MD

    Goethe University

    PRINCIPAL INVESTIGATOR

  • Erhard Seifried, MD

    German Red Cross Blood Service Baden-Württemberg-Hessen, Institute for Transfusion Medicine and Immunohematology of the Goethe University Hospital, Frankfurt

    PRINCIPAL INVESTIGATOR

  • Eva Herrmann

    Institute of Biostatistics and Mathematical Modeling, Goethe University Frankfurt

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. Dr. Kai Zacharowski

Study Record Dates

First Submitted

March 19, 2013

First Posted

March 29, 2013

Study Start

January 1, 2013

Primary Completion

July 1, 2015

Study Completion

September 1, 2015

Last Updated

September 7, 2015

Record last verified: 2015-09

Locations

DE(4)