A Pilot Study of Post Operative Iron Infusion for the Treatment of Anaemia in Trauma Patients

Phase 4

Recruiting

• Conditions: Anaemia; Trauma; Blood - Anaemia; Emergency medicine - Other emergency care

• Registration Number: ACTRN12624000410550
• Lead Sponsor: Alfred Health - Department of Anaesthesiology and Perioperative Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-04
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patients over the age of 18 admitted to the Alfred for treatment of trauma with post-operative anaemia at the time of enrolment.

Exclusion Criteria

•Patient refusal
•Iron transfusion prior to admission, surgery or intraoperatively
•Hb <80 – these patients will be referred for treatment and transfusion
•Patients with pre-existing haematological disorders or any condition associated with iron overload
•Traumatic brain injury, neurological deficit or cognitive impairment that would impact compliance with surveys and follow up investigations
•Patients with known hypersensitivity to IV iron

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Consent rate[percentage of patients approached for recruitment that consent to take part in the trial as recorded in screening and enrolment logs At conclusion of recruitment];Successful study drug administration[Number/percentage of infusions that are administered successfully without unblinding as identified by successful sign off of administration by the treating team on electronic medical records At time of infusion for each patient];Follow up attendance rate[Number/percentage of patients that attend day 30 follow up post infusion will be calculated by the acquisition of a complete data set of follow up questionnaires (WHODAS 2.0, QoR 15 and FACIT-Fatigue). This will be assessed by review of study records/database At day 30 post infusion for each patient]

Secondary Outcome Measures

Name	Time	Method
Hb level[Results collected off electronic medical records (EMR) from routine blood tests at trauma follow up appointment Day 30 post infusion follow up for each patient];Days alive and out of hospital[Collection of patient discharge destinations, days spent at own home and readmissions following infusion from EMR and follow up with participants (telephone or in person) Day 30 post infusion follow up for each patient];Disability [WHODAS 2.0 Questionnaire (validated for level of functioning and disability assessment) Participants will complete baseline prior to infusion and at 30 day follow-up];Fatigue[13 item FACIT-Fatigue scale (validated for assessment of anaemia-related fatigue) Participants will complete baseline prior to infusion and at 30 day follow-up];Quality of Recovery[QoR-15 Questionnaire (validated for assessment of quality of post-operative recovery) Participants will complete at 30 day follow-up]