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ProPBM : A Modified Patient Blood Management Protocol

Primary Purpose

Iron-deficiency

Status
Unknown status
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
MonoFer
Sponsored by
Ministry of Health, Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Iron-deficiency focused on measuring intravenous iron isomaltoside(monofer), iron deficiency, anaemia, patient blood management

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University Malaya Medical Centre, Jalan UniversitiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

ProPBM

Standard Care

Arm Description

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

patient will received standard hospital practise

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
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.
Mortality rate
To assess the incidence of mortality after surgery in both ProPBM arm and standard arm
Total hospital stay
Participants will be followed for the duration of hospital stay

Full Information

First Posted
March 1, 2019
Last Updated
October 30, 2019
Sponsor
Ministry of Health, Malaysia
Collaborators
University of Malaya
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1. Study Identification

Unique Protocol Identification Number
NCT03888768
Brief Title
ProPBM : A Modified Patient Blood Management Protocol
Official Title
ProPBM : A Randomised Control Trial Comparing a Modified Patient Blood Management Protocol Against Standard Care for Patients Undergoing Major Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2019 (Actual)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ministry of Health, Malaysia
Collaborators
University of Malaya

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Iron-deficiency
Keywords
intravenous iron isomaltoside(monofer), iron deficiency, anaemia, patient blood management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
ProPBM arm and standard Care arm
Masking
None (Open Label)
Masking Description
patient will be randomised into ProPBM and standard care arm
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ProPBM
Arm Type
Active Comparator
Arm Description
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
Arm Title
Standard Care
Arm Type
No Intervention
Arm Description
patient will received standard hospital practise
Intervention Type
Drug
Intervention Name(s)
MonoFer
Other Intervention Name(s)
isomaltoside
Intervention Description
Administration of IV Monofer will be given according to body weight as recommended by the drug manufacturer.
Primary Outcome Measure Information:
Title
Incidence of perioperative allogenic blood transfusion.
Description
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
Secondary Outcome Measure Information:
Title
Change in haemoglobin (Hb) concentrations from baseline
Description
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
Title
Quality of Life of patient
Description
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
Title
Postoperative Morbidity
Description
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
Title
Mortality rate
Description
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
Title
Total hospital stay
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jenq Uei Tan
Phone
+60165213692
Email
jenquei84@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin Ng
Phone
+60122987708
Email
nivekng@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Ng
Organizational Affiliation
UMMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Malaya Medical Centre, Jalan Universiti
City
Kuala Lumpur
State/Province
Wilayah Persekutuan Kuala Lumpur
ZIP/Postal Code
59100
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
UM
Phone
0379494422
Email
ummc@ummc.edu.my
First Name & Middle Initial & Last Name & Degree
kevin ng
Phone
0122987708
Email
nivekng@gmail.com
First Name & Middle Initial & Last Name & Degree
Kevin Ng

12. IPD Sharing Statement

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