The Benefit of Autologous Blood Transfusion in Total Hip Arthroplasty

Hip Arthroplasty Clinical Trial

Official title:

The Benefit of Autologous Blood Transfusion in Total Hip Arthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04304287
• Other study ID #: Orthopedia/autotransfusion
• Status: Completed
• Phase: N/A
• Start date: January 16, 2011
• Est. completion date: June 15, 2015

Study information

• Verified date: March 2020
• Source: Clinical Hospital Centre Zagreb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: June 15, 2015
• Est. primary completion date: June 15, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hip Arthroplasty
• Transfusion

Intervention

Procedure:
• Preoperative autologous blood donation, 14 days before surgery

• Preoperative autologous blood donation, 72 hours before surgery

• Without preoperative blood donation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Clinical Hospital Centre Zagreb

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Need for autologous blood transfusion	Based on blood count and hemodynamic stability	6 days
Primary	Need for homologous blood transfusion	Based on blood count and hemodynamic stability	6 days
Primary	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
Primary	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	Length of hospital stay	measure of length of hospital stay	6 days