NCT03888768

ProPBM : A Modified Patient Blood Management Protocol

ProPBM : A Randomised Control Trial Comparing a Modified Patient Blood Management Protocol Against Standard Care for Patients Undergoing Major Surgery

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Ministry of Health, Malaysia · Other Government
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The introduction of a modified perioperative patient blood management protocol with intravenous iron intervention for iron deficiency anaemic patients would reduce the need for allogenic blood transfusion and reduce perioperative morbidity and mortality.

Detailed description

Patient blood management (PBM), refers to "the timely application of evidence based medical and surgical concepts designed to maintain haemoglobin concentration, optimise haemostasis and minimize blood loss in an effort to improve patient outcome. PBM relies on three corresponding aspects: 1. Optimising haemopoiesis, 2. Minimising bleeding and blood loss 3. Harnessing and optimising physiological tolerance of anaemia. Therefore, this randomised control trial aims to study the effect of applying a modified patient blood management protocol on the perioperative allogenic blood transfusion incidence, mortality and morbidity in patients undergoing major surgery in gynaecology, intraabdominal surgery and orthopaedics comparing with current practice.

Conditions

• Iron-deficiency

Interventions

Type	Name	Description
DRUG	MonoFer	Administration of IV Monofer will be given according to body weight as recommended by the drug manufacturer.

Timeline

• Start date: 2019-08-01
• Primary completion: 2021-10-01
• Completion: 2021-12-01
• First posted: 2019-03-25
• Last updated: 2019-11-01

Locations

1 site across 1 country: Malaysia