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Completed

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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Key information

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, 14 days before surgery

Procedure

Preoperative autologous blood donation, 72 hours before surgery

Procedure

Without preoperative blood donation

Procedure

Primary outcomes

  1. 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

  2. Need for autologous blood transfusion

    Time frame: 6 days

    Based on blood count and hemodynamic stability

  3. Need for homologous blood transfusion

    Time frame: 6 days

    Based on blood count and hemodynamic stability

  4. 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

  5. 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

  1. 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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