ProPBM : A Modified Patient Blood Management Protocol

Study Overview
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Brief Summary
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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
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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: Optimising haemopoiesis, Minimising bleeding and blood loss 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.

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

Conditions
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Iron-deficiency

Intervention / Treatment
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* Drug: MonoFer


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: ProPBM arm and standard Care arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ProPBM<br>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<br>* Administration of IV Monofer will be given according to body weight as recommended by the drug manufacturer.<br>* Other names: isomaltoside;|
| No Intervention: Standard Care<br>patient will received standard hospital practise | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intravenous iron isomaltoside(monofer), iron deficiency, anaemia, patient blood management