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

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.

Study Overview

• Status: Unknown
• Conditions: Iron-deficiency
• Intervention / Treatment: Drug: MonoFer

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.

• Study Type: Interventional
• Enrollment (Anticipated): 180
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Malaysia
  • Wilayah Persekutuan Kuala Lumpur
    • Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 59100
      • Recruiting
      • University Malaya Medical Centre, Jalan Universiti
      • Contact: UM; Phone Number: 0379494422; Email: ummc@ummc.edu.my
      • Contact: kevin ng; Phone Number: 0122987708; Email: nivekng@gmail.com
      • Principal Investigator: Kevin Ng

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: ProPBM; 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	Drug: MonoFer; Administration of IV Monofer will be given according to body weight as recommended by the drug manufacturer.; Other Names: isomaltoside
NO_INTERVENTION: Standard Care; patient will received standard hospital practise

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of perioperative allogenic blood transfusion.	To assess the incidence of allogenic blood transfusion occurring within the total length of hospital stay within the same admission of a surgical procedure performed under general or regional anaesthesia	Participants will be followed from date of hospital entry until date of discharge up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in haemoglobin (Hb) concentrations from baseline	To assess the extent of increase in preoperative hemoglobin levels(baseline) and hemoglobin level one day before surgery, after the administration of IV MonoFer in ProPBM arm	Preoperative basline and one day before surgery after MonoFer administration expected up to 2 weeks
Quality of Life of patient	To assess patient's quality of life using Short Form (12) Health Survey(SF-12) is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight domain scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability.	preoperative (baseline), one month, six month
Postoperative Morbidity	To assess postoperative morbidity using Postoperative Morbidity Survey(POMS).Patients are assessed for diagnostic features in nine domains (pulmonary, infectious, renal, gastrointestinal, cardiovascular, neurological, haematological, wound and pain). For each domain, either presence or absence of morbidity is recorded on the basis of objective criteria.	Day one postoperative, postoperative one week,postoperative one month, postoperative six month
Mortality rate	To assess the incidence of mortality after surgery in both ProPBM arm and standard arm	Participants will be followed up expected till 6 months
Total hospital stay	Participants will be followed for the duration of hospital stay	Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Collaborators and Investigators

• Sponsor: Ministry of Health, Malaysia
• Collaborators: University of Malaya
• Investigators: Principal Investigator: Kevin Ng, UMMC

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2019
• Primary Completion (ANTICIPATED): October 1, 2021
• Study Completion (ANTICIPATED): December 1, 2021

Study Registration Dates

• First Submitted: March 1, 2019
• First Submitted That Met QC Criteria: March 22, 2019
• First Posted (ACTUAL): March 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 1, 2019
• Last Update Submitted That Met QC Criteria: October 30, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: anaemia; iron deficiency; patient blood management; intravenous iron isomaltoside(monofer)
• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Anemia, Hypochromic; Anemia; Iron Metabolism Disorders; Anemia, Iron-Deficiency
• Other Study ID Numbers: 46050

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No