NCT04398238

Brief Summary

Retrospective observational study: impact of a peri-operative patient blood management program (PBM) on transfusion rates of patients undergoing elective hip replacement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

May 12, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 21, 2020

Completed
1.2 years until next milestone

Study Start

First participant enrolled

August 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 4, 2023

Completed
Last Updated

May 30, 2023

Status Verified

May 1, 2023

Enrollment Period

1.3 years

First QC Date

May 12, 2020

Last Update Submit

May 26, 2023

Conditions

Anemia (Diagnosis)Iron-deficiencyTransfusionArthroplasty

Keywords

patient blood managementanemiaArthroplasty

Outcome Measures

Primary Outcomes (1)

  • transfusion rates

    percentage of patients undergoing hip replacement who receive at least one unit of concentrated red cells during or after surgery

    from day of surgery till day of discharge, up to 60 days

Secondary Outcomes (3)

  • minimum hemoglobin

    from day of surgery till day of discharge, up to 60 days

  • hemoglobin at discharge

    from day of surgery till day of discharge, up to 60 days

  • length of stay

    from day of surgery till day of discharge, up to 60 days

Study Arms (2)

Pre-PBM

patients screened for surgery before the implementation of PBM program: pre-operative evaluation and treatment according to usual care

post-PBM

patients screened for surgery after the implementation of PBM program (3 months allowed for training/optimization): all patients with pre-operative hemoglobin \< 13g/dl undergo screening for causes and treatment as needed.

Combination Product: evaluation by transfusion medicine specialist

Interventions

evaluation by transfusion medicine specialistCOMBINATION_PRODUCT

screening for anemia causes and treatment: iron/folate/vitamin B12 supplementation, Erythropoietin administration if indicated

post-PBM

Eligibility Criteria

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

All patients of age \> 18 who undergo screening and surgery for hip athroplasty in the selected time-frame

You may qualify if:

  • undergoing elective hip replacement in the selected time-frame
  • American Society of Anesthesiology (ASA) status 1-2-3
  • age \>18

You may not qualify if:

  • patients not undergoing screening as outpatients at pre-operative clinic

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sandra Giannone

Bologna, BO, 40128, Italy

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: 29944518BACKGROUND

  • Munoz M, Acheson AG, Auerbach M, Besser M, Habler O, Kehlet H, Liumbruno GM, Lasocki S, Meybohm P, Rao Baikady R, Richards T, Shander A, So-Osman C, Spahn DR, Klein AA. International consensus statement on the peri-operative management of anaemia and iron deficiency. Anaesthesia. 2017 Feb;72(2):233-247. doi: 10.1111/anae.13773. Epub 2016 Dec 20.

    PMID: 27996086BACKGROUND

  • Rineau E, Chaudet A, Chassier C, Bizot P, Lasocki S. Implementing a blood management protocol during the entire perioperative period allows a reduction in transfusion rate in major orthopedic surgery: a before-after study. Transfusion. 2016 Mar;56(3):673-81. doi: 10.1111/trf.13468. Epub 2016 Jan 8.

    PMID: 26748489BACKGROUND

MeSH Terms

Conditions

AnemiaDiseaseAnemia, Iron-Deficiency

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsAnemia, HypochromicIron DeficienciesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Stefano Bonarelli, MD

    Istituto Ortopedico Rizzoli

    PRINCIPAL INVESTIGATOR

  • Sandra Giannone, MD

    Istituto Ortopedico Rizzoli

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2020

First Posted

May 21, 2020

Study Start

August 1, 2021

Primary Completion

November 25, 2022

Study Completion

April 4, 2023

Last Updated

May 30, 2023

Record last verified: 2023-05

Locations

IT(1)