ProPBM : A Modified Patient Blood Management Protocol

Ministry of Health, Malaysia

Status: Unknown

Conditions: Iron-deficiency

Treatments: Drug: MonoFer

Study type: Interventional

Funder types: Other

Identifiers

NCT03888768

46050

Details and patient eligibility

About

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.

Full 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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Undergoing major surgery in gynaecology, gastrointestinal surgery and orthopaedics
• Major surgery defined as either Intrabdominal surgery or main joint surgery, Risk of blood loss >15% blood volume
• Aged between 18 to 80 years of age
• The patient must be willing and able to provide written informed consent for the study

Exclusion criteria

• Allergy or known sensitivity to parenteral iron
• Hypersensitivity to the active substance, Iron(III) Isomaltoside or any of its excipients listed in the summary of product characteristics
• Patients with iron overload

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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180 participants in 2 patient groups

ProPBM

Active Comparator group

Description:

Pre-operative: patient will be screened for iron deficiency and anemia and administered IV monofer Intra-operative:IV tranexamic Acid 1gm will be administered at the beginning of surgery and blood transfusion triggered by Allowable blood loss Post-operative: IV Iron monofer will be given to those with estimated blood loss \>1L and subsequent post operative follow up till 6month

Treatment:

Drug: MonoFer

Standard Care

No Intervention group

Description:

patient will received standard hospital practise