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| Name | Class |
|---|---|
| University of Malaya | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ProPBM | Active Comparator | 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 |
|
| Standard Care | No Intervention | patient will received standard hospital practise |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MonoFer | Drug | Administration of IV Monofer will be given according to body weight as recommended by the drug manufacturer. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jenq Uei Tan | Contact | +60165213692 | jenquei84@gmail.com | |
| Kevin Ng | Contact | +60122987708 | nivekng@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Kevin Ng | UMMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Malaya Medical Centre, Jalan Universiti | Recruiting | Kuala Lumpur | Kuala Lumpur | 59100 | Malaysia |
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| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| D000090463 | Iron Deficiencies |
| D000740 | Anemia |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D019189 | Iron Metabolism Disorders |
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ProPBM arm and standard Care arm
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patient will be randomised into ProPBM and standard care arm
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| 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 |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |