NCT Number: NCT04304287
The Benefit of Autologous Blood Transfusion in Total Hip Arthroplasty
The investigators studied the benefit of preoperative autologous blood donation in participants who undergo total hip arthroplasty. Study is made as a prospective and randomized.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
About this study
Total hip arthroplasty is procedure followed with large perioperative and postoperative blood loss. In order to avoid the application of large amounts of allogeneic blood, preoperative autologous blood donation as a tipe of autologous transfusion have been developed.
In this study, the investigators studied the benefit of preoperative autologous blood donation in participants who undergo total hip arthroplasty. Study is made as a prospective and randomized.
Participants were divided into three groups: the first group donated one dose of autologous blood 14 days preoperatively, the second group donated one dose of autologous blood 72 hours preoperatively and a third group was not donated autologous blood.
The blood parameters, hemodynamic stability, bleeding, the need for application of autologous or homologous blood and length of hospital stay were compared.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- subject older than 18 years
- subject has primary coxarthrosis
- subject has indication for total hip replacement
Exclusion criteria
- subject has secondary coxarthrosis
- subject has need for revision endoprosthesis
- history of autoimmune, malignancy or coagulation disorder
- history of myocardial infarct or cerebrovascular insult in last 6 months
- history of angina pectoris and unregulated hypertension
- history of renal or liver failure
Treatment and study plan
Preoperative autologous blood donation, 72 hours before surgery
ProcedureWithout preoperative blood donation
ProcedurePrimary outcomes
-
Patient red blood cells value
Time frame: 6 days
analysis of blood sample day before surgery, 3 hours after surgery, on first, second, fifth postoperative day and on sixth postoperative day
-
Need for autologous blood transfusion
Time frame: 6 days
Based on blood count and hemodynamic stability
-
Need for homologous blood transfusion
Time frame: 6 days
Based on blood count and hemodynamic stability
-
Patient hemoglobin value
Time frame: 6 days
analysis of blood sample day before surgery, 3 hours after surgery, on first, second, fifth postoperative day and on sixth postoperative day
-
Patient hematocrit value
Time frame: 6 days
analysis of blood sample day before surgery, 3 hours after surgery, on first, second, fifth postoperative day and on sixth postoperative day
Secondary outcomes
-
Length of hospital stay
Time frame: 6 days
measure of length of hospital stay
Sponsors and collaborators
Lead sponsor
Clinical Hospital Centre Zagreb
Other
Registry information
Important dates
- Study start
- 2011
- Primary completion
- 2013
- Study completion
- 2015
- First posted
- Mar 11, 2020
- Registry last updated
- Mar 23, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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