An interventional study of MonoFer in Iron-deficiency, sponsored by Ministry of Health, Malaysia. Status unknown at 1 site in Malaysia. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-11-01.
Sponsored by Ministry of Health, Malaysia · Not applicable, Interventional, and Treatment
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.
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:
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.
644 studies on the registry are indexed under Anemia, Iron-Deficiency; 105 are open to participants now.
This study's planned enrollment of 180 is above the median of 100 across 503 interventional studies indexed under Anemia, Iron-Deficiency.
Browse Anemia, Iron-Deficiency studies →Ministry of Health, Malaysia is the lead sponsor of 27 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
patient will received standard hospital practise
Administration of IV Monofer will be given according to body weight as recommended by the drug manufacturer.
Also known as: isomaltoside
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
Time frame: Participants will be followed from date of hospital entry until date of discharge up to 6 months
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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Participants will be followed up expected till 6 months
Total hospital stay
Participants will be followed for the duration of hospital stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Ministry of Health, Malaysia