Clinical trial NCT04398238: Transfusion Rates in Total Hip Replacement Before/After the Implementation of a Patient Blood Management Program.
Official title: "Change in Transfusion Rates of Patients Undergoing Elective Total Hip Replacement Before/After the Implementation of a Peri-operative Patient Blood Management Program: a Retrospective Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia (Diagnosis)
Iron-deficiency
Transfusion
Arthroplasty
Keywords: patient blood management
anemia
Arthroplasty
Lead sponsor: Istituto Ortopedico Rizzoli
Sponsor class: OTHER
First posted: 2020-05-21
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients of age \> 18 who undergo screening and surgery for hip athroplasty in the selected time-frame

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

Detailed description: A Patient Blood Management (PBM) program was implemented in year 2019 in our institution: patient scheduled for elective total hip replacement underwent pre-operative screening about one month before surgery, and those with pre-operative hemoglobin \< 13 g/dl were screened for possible causes and treatment of anemia.

Data from two different time frames, before and after the implementation of the program, were collected to study the change in clinical outcomes such as transfusion rates, length of stay, etc.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: transfusion rates
timeFrame: from day of surgery till day of discharge, up to 60 days
Secondary outcomes:
measure: minimum hemoglobin
timeFrame: from day of surgery till day of discharge, up to 60 days
measure: hemoglobin at discharge
timeFrame: from day of surgery till day of discharge, up to 60 days
measure: length of stay
timeFrame: from day of surgery till day of discharge, up to 60 days
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Sandra Giannone
state: BO
Study officials:
affiliation: Istituto Ortopedico Rizzoli
name: Stefano Bonarelli, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Istituto Ortopedico Rizzoli
name: Sandra Giannone, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.