NCT03888768

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2019

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 25, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

August 1, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

November 1, 2019

Status Verified

October 1, 2019

Enrollment Period

2.2 years

First QC Date

March 1, 2019

Last Update Submit

October 30, 2019

Conditions

Iron-deficiency

Keywords

intravenous iron isomaltoside(monofer)iron deficiencyanaemiapatient blood management

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change in haemoglobin (Hb) concentrations from baseline

    Preoperative basline and one day before surgery after MonoFer administration expected up to 2 weeks

  • Quality of Life of patient

    preoperative (baseline), one month, six month

  • Postoperative Morbidity

    Day one postoperative, postoperative one week,postoperative one month, postoperative six month

  • Mortality rate

    Participants will be followed up expected till 6 months

  • Total hospital stay

    Participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Study Arms (2)

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

Drug: MonoFer

Standard Care

NO INTERVENTION

patient will received standard hospital practise

Interventions

MonoFerDRUG

Administration of IV Monofer will be given according to body weight as recommended by the drug manufacturer.

Also known as: isomaltoside
ProPBM

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Malaya Medical Centre, Jalan Universiti

Kuala Lumpur, Kuala Lumpur, 59100, Malaysia

RECRUITING

MeSH Terms

Conditions

Anemia, Iron-DeficiencyIron DeficienciesAnemia

Condition Hierarchy (Ancestors)

Anemia, HypochromicHematologic DiseasesHemic and Lymphatic DiseasesIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Kevin Ng

    UMMC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenq Uei Tan

CONTACT

+60165213692jenquei84@gmail.com

Kevin Ng

CONTACT

+60122987708nivekng@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
patient will be randomised into ProPBM and standard care arm
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: ProPBM arm and standard Care arm
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Trainee of Master of Anaesthesiology University of Malaya

Study Record Dates

First Submitted

March 1, 2019

First Posted

March 25, 2019

Study Start

August 1, 2019

Primary Completion

October 1, 2021

Study Completion

December 1, 2021

Last Updated

November 1, 2019

Record last verified: 2019-10

Locations

MY(1)