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.

Study Overview

• Status: Completed
• Conditions: Hip Arthroplasty; Transfusion
• Intervention / Treatment: Procedure: Preoperative autologous blood donation, 14 days before surgery; Procedure: Preoperative autologous blood donation, 72 hours before surgery; Procedure: Without preoperative blood donation

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 Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; Preoperative blood donations 14 day before total hip replacement procedure Donation of one dose of autologous blood 14 day before total hip replacement procedure	Procedure: Preoperative autologous blood donation, 14 days before surgery
Active Comparator: Active comparator; Preoperative blood donation 72 hours before total hip replacement procedure Donation of one dose of autologous blood 72 hours before total hip replacement procedure	Procedure: Preoperative autologous blood donation, 72 hours before surgery
Other: Other; Without preoperative blood donation	Procedure: Without preoperative blood donation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	measure of length of hospital stay	6 days

Collaborators and Investigators

• Sponsor: Clinical Hospital Centre Zagreb
• Investigators: Study Director: Domagoj Delimar, MD, Clinical Hospital Centre Zagreb

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2011
• Primary Completion (Actual): June 15, 2013
• Study Completion (Actual): June 15, 2015

Study Registration Dates

• First Submitted: February 27, 2020
• First Submitted That Met QC Criteria: March 7, 2020
• First Posted (Actual): March 11, 2020

Study Record Updates

• Last Update Posted (Actual): March 23, 2020
• Last Update Submitted That Met QC Criteria: March 18, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: total hip arthroplasty; autologous blood donation
• Other Study ID Numbers: Orthopedia/autotransfusion

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No