The Benefit of Autologous Blood Transfusion in Total Hip Arthroplasty

Not Applicable

Completed

• Conditions: Transfusion; Hip Arthroplasty
• Interventions: Procedure: Preoperative autologous blood donation, 14 days before surgery; Procedure: Preoperative autologous blood donation, 72 hours before surgery; Procedure: Without preoperative blood donation

• Registration Number: NCT04304287
• Lead Sponsor: Clinical Hospital Centre Zagreb

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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-01-16
• Primary Completion: 2013-06-15
• Study Completion: 2015-06-15
• Study First Submitted: 2020-02-27
• Status Verified: 2020-03
• Study First Submitted QC: 2020-03-07
• Study First Posted: 2020-03-11
• Last Update Submitted: 2020-03-18
• Last Update Posted: 2020-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Preoperative autologous blood donation, 14 days before surgery	Preoperative 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	Preoperative autologous blood donation, 72 hours before surgery	Preoperative blood donation 72 hours before total hip replacement procedure Donation of one dose of autologous blood 72 hours before total hip replacement procedure
Other	Without preoperative blood donation	Without preoperative blood donation

Primary Outcome Measures

Name	Time	Method
Patient hematocrit value	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	6 days	Based on blood count and hemodynamic stability
Need for homologous blood transfusion	6 days	Based on blood count and hemodynamic stability
Patient hemoglobin value	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 red blood cells value	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 Outcome Measures

Name	Time	Method
Length of hospital stay	6 days	measure of length of hospital stay