Clinical trial NCT03888768: ProPBM : A Modified Patient Blood Management Protocol
Official title: ProPBM : A Randomised Control Trial Comparing a Modified Patient Blood Management Protocol Against Standard Care for Patients Undergoing Major Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Iron-deficiency
Keywords: intravenous iron isomaltoside(monofer)
iron deficiency
anaemia
patient blood management
Lead sponsor: Ministry of Health, Malaysia
Sponsor class: OTHER_GOV
Collaborators: name: University of Malaya
First posted: 2019-03-25
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: ProPBM arm and standard Care arm
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence of perioperative allogenic blood transfusion.
timeFrame: Participants will be followed from date of hospital entry until date of discharge up to 6 months
Secondary outcomes:
measure: Change in haemoglobin (Hb) concentrations from baseline
timeFrame: Preoperative basline and one day before surgery after MonoFer administration expected up to 2 weeks
measure: Quality of Life of patient
timeFrame: preoperative (baseline), one month, six month
measure: Postoperative Morbidity
timeFrame: Day one postoperative, postoperative one week,postoperative one month, postoperative six month
measure: Mortality rate
timeFrame: Participants will be followed up expected till 6 months
measure: Total hospital stay
timeFrame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Other outcomes:
Locations:
city: Kuala Lumpur
country: Malaysia
facility: University Malaya Medical Centre, Jalan Universiti
state: Wilayah Persekutuan Kuala Lumpur
Study officials:
affiliation: UMMC
name: Kevin Ng
role: PRINCIPAL_INVESTIGATOR
References: