Iron-deficiencyNCT03888768
ProPBM : A Modified Patient Blood Management Protocol
A study testing MonoFer in people with Iron-deficiency, run by Ministry of Health, Malaysia at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Iron-deficiency
- What is being tested?
- MonoFer
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Aug 2019to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site, 1 recruiting
- Recruiting
University Malaya Medical Centre, Jalan Universiti
Kuala Lumpur, Kuala Lumpur, 59100
UM, 0379494422, ummc@ummc.edu.my
kevin ng, 0122987708, nivekng@gmail.com
About this study
Official title: ProPBM : A Randomised Control Trial Comparing a Modified Patient Blood Management Protocol Against Standard Care for Patients Undergoing Major Surgery
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.
Read the 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.
- Conditions
- Iron-deficiency
- Being tested
- MonoFer
- Keywords
- intravenous iron isomaltoside(monofer), iron deficiency, anaemia, patient blood management
- Medical subject headings
- Anemia, Iron-Deficiency, Iron Deficiencies, Anemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MonoFerDrug
Also called isomaltoside
Administration of IV Monofer will be given according to body weight as recommended by the drug manufacturer.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: MonoFer |
| Standard Care | No intervention | patient will received standard hospital practise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Participants will be followed from date of hospital entry until date of discharge up to 6 months
Secondary outcomes (5)
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
Measured: 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.
Measured: 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.
Measured: 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
Measured: Participants will be followed up expected till 6 months
Total hospital stay
Participants will be followed for the duration of hospital stay
Measured: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2019
- Study start1 Aug 2019
- Primary completionOct 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron-deficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- ProPBM arm and standard Care arm
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Health, Malaysia
- Sponsor type
- Other government
- Collaborators
- University of Malaya
- Responsible party
- Principal investigator, Tan Jenq Uei, Ministry of Health, Malaysia
- Investigators
- Kevin Ng, Principal investigator, UMMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03888768
- Sponsor's protocol ID
- 46050
- Status last verified
- Oct 2019
- First submitted
- 1 Mar 2019
- Last updated
- 1 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ProPBM : A Randomised Control Trial Comparing a Modified Patient Blood Management Protocol Against Standard Care for Patients Undergoing Major Surgery
- ClinicalTrials.gov ID
- NCT03888768
- Acronym / sponsor ID
- 46050
- Conditions
- Iron-deficiency
- Keywords
- intravenous iron isomaltoside(monofer), iron deficiency, anaemia, patient blood management
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Ministry of Health, MalaysiaOther government
- Collaborators
- University of Malaya
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- Oct 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 25 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- ProPBM arm and standard Care arm
| Arm | Type | Receives |
|---|---|---|
| ProPBM | Active comparator | Drug: MonoFerPre-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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MonoFerAlso: isomaltosideAdministration of IV Monofer will be given according to body weight as recommended by the drug manufacturer. | Drug | ProPBM |
Primary outcome
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
5 secondary outcomes
Change in haemoglobin (Hb) concentrations from baseline
Time frame: Preoperative basline and one day before surgery after MonoFer administration expected up to 2 weeks
Quality of Life of patient
Time frame: preoperative (baseline), one month, six month
Postoperative Morbidity
Time frame: Day one postoperative, postoperative one week,postoperative one month, postoperative six month
Mortality rate
Time frame: Participants will be followed up expected till 6 months
Total hospital stay
Time frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Ng principal investigator
UMMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MonoFer in people with Iron-deficiency, run by Ministry of Health, Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jenq Uei Tan (+60165213692, jenquei84@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2019.