The Benefit of Autologous Blood Transfusion in Total Hip Arthroplasty
1 other identifier
interventional
75
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2011
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2015
CompletedFirst Submitted
Initial submission to the registry
February 27, 2020
CompletedFirst Posted
Study publicly available on registry
March 11, 2020
CompletedMarch 23, 2020
March 1, 2020
2.4 years
February 27, 2020
March 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Patient red blood cells value
analysis of blood sample day before surgery, 3 hours after surgery, on first, second, fifth postoperative day and on sixth postoperative day
6 days
Need for autologous blood transfusion
Based on blood count and hemodynamic stability
6 days
Need for homologous blood transfusion
Based on blood count and hemodynamic stability
6 days
Patient hemoglobin value
analysis of blood sample day before surgery, 3 hours after surgery, on first, second, fifth postoperative day and on sixth postoperative day
6 days
Patient hematocrit value
analysis of blood sample day before surgery, 3 hours after surgery, on first, second, fifth postoperative day and on sixth postoperative day
6 days
Secondary Outcomes (1)
Length of hospital stay
6 days
Study Arms (3)
Experimental
EXPERIMENTALPreoperative blood donations 14 day before total hip replacement procedure Donation of one dose of autologous blood 14 day before total hip replacement procedure
Active comparator
ACTIVE COMPARATORPreoperative blood donation 72 hours before total hip replacement procedure Donation of one dose of autologous blood 72 hours before total hip replacement procedure
Other
OTHERWithout preoperative blood donation
Interventions
Eligibility Criteria
You may qualify if:
- subject older than 18 years
- subject has primary coxarthrosis
- subject has indication for total hip replacement
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Officials
- STUDY DIRECTOR
Domagoj Delimar, MD
Clinical Hospital Centre Zagreb
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
February 27, 2020
First Posted
March 11, 2020
Study Start
January 16, 2011
Primary Completion
June 15, 2013
Study Completion
June 15, 2015
Last Updated
March 23, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share