ProPBM : A Modified Patient Blood Management Protocol

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2021

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.

Interventions

  • Drug: MonoFer
    • Administration of IV Monofer will be given according to body weight as recommended by the drug manufacturer.

Arms, Groups and Cohorts

  • 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
  • No Intervention: Standard Care
    • patient will received standard hospital practise

Clinical Trial Outcome Measures

Primary Measures

  • Incidence of perioperative allogenic blood transfusion.
    • Time Frame: Participants will be followed from date of hospital entry until date of discharge up to 6 months
    • 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

Secondary Measures

  • Change in haemoglobin (Hb) concentrations from baseline
    • Time Frame: Preoperative basline and one day before surgery after MonoFer administration expected up to 2 weeks
    • 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
  • Quality of Life of patient
    • Time Frame: preoperative (baseline), one month, six month
    • 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.
  • Postoperative Morbidity
    • Time Frame: Day one postoperative, postoperative one week,postoperative one month, postoperative six month
    • 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.
  • Mortality rate
    • Time Frame: Participants will be followed up expected till 6 months
    • To assess the incidence of mortality after surgery in both ProPBM arm and standard arm
  • Total hospital stay
    • Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
    • Participants will be followed for the duration of hospital stay

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ministry of Health, Malaysia
  • Collaborator
    • University of Malaya
  • Provider of Information About this Clinical Study
    • Principal Investigator: Tan Jenq Uei, Trainee of Master of Anaesthesiology University of Malaya – Ministry of Health, Malaysia
  • Overall Official(s)
    • Kevin Ng, Principal Investigator, UMMC
  • Overall Contact(s)
    • Jenq Uei Tan, +60165213692, jenquei84@gmail.com

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