A prospective, randomized, controlled trial of retransfusion of intra-operatively collected filtered whole blood in total hip surgery.

Phase 4

Completed

• Conditions: retransfusion of autologous blood; Sangvia Blood Management System; 10043413

• Registration Number: NL-OMON33014
• Lead Sponsor: AstraTech AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 150

Inclusion Criteria

- provision of informed consent
- scheduled for primary or secondary, cemented or non-cemented, total hip arthroplasty
- ASA classification I-III

Exclusion Criteria

- current symptoms of haemophilia
- current symptoms of hyperkalaemia
- current symptoms of impaired renal function (normal reference level)
- current untreated anaemia (Hb level < 7 mmo/L)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Frequency and amount of allogeneic blood transfusion</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Post-operative infection rate (SIRS reaction, clinical symptoms, wound<br /><br>infection, CRP and LPC)<br /><br>- Post-operative antibiotic use<br /><br>- Length of hospital stay<br /><br>- Post-operative haemoglobin concentration<br /><br>- Demographical data (e.g. vital signs, age, gender etc)<br /><br>- Health status questionnaire (i.e. EQ-5D)</p><br>