ProPBM : A Modified Patient Blood Management Protocol

• ClinicalTrials.gov Identifier: NCT03888768
• Recruitment Status: Unknown
• First Posted: March 25, 2019
• Last Update Posted: November 1, 2019
• Sponsor: Ministry of Health, Malaysia
• Collaborator: University of Malaya
• Information provided by (Responsible Party): Tan Jenq Uei, Ministry of Health, Malaysia

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.

Condition or disease	Intervention/treatment	Phase
Iron-deficiency	Drug: MonoFer	Not Applicable

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:

1. Optimising haemopoiesis,
2. Minimising bleeding and blood loss
3. 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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: ProPBM arm and standard Care arm
• Masking: None (Open Label)
• Masking Description: patient will be randomised into ProPBM and standard care arm
• Primary Purpose: Treatment
• Official Title: ProPBM : A Randomised Control Trial Comparing a Modified Patient Blood Management Protocol Against Standard Care for Patients Undergoing Major Surgery
• Actual Study Start Date: August 1, 2019
• Estimated Primary Completion Date: October 2021
• Estimated Study Completion Date: December 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: ProPBM; 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; Administration of IV Monofer will be given according to body weight as recommended by the drug manufacturer.; Other Name: isomaltoside
No Intervention: Standard Care; patient will received standard hospital practise

Outcome Measures

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. Change in haemoglobin (Hb) concentrations from baseline [ Time Frame: Preoperative basline and one day before surgery after MonoFer administration expected up to 2 weeks ]
   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
2. Quality of Life of patient [ Time Frame: preoperative (baseline), one month, six month ]
   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.
3. Postoperative Morbidity [ Time Frame: Day one postoperative, postoperative one week,postoperative one month, postoperative six month ]
   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.
4. Mortality rate [ Time Frame: Participants will be followed up expected till 6 months ]
   To assess the incidence of mortality after surgery in both ProPBM arm and standard arm
5. Total hospital stay [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 weeks ]
   Participants will be followed for the duration of hospital stay

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Contacts

Contact: Jenq Uei Tan; +60165213692; jenquei84@gmail.com

Contact: Kevin Ng; +60122987708; nivekng@gmail.com

Locations

Malaysia

University Malaya Medical Centre, Jalan Universiti; Recruiting

Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia, 59100

Contact: UM 0379494422 ummc@ummc.edu.my

Contact: kevin ng 0122987708 nivekng@gmail.com

Principal Investigator: Kevin Ng

Sponsors and Collaborators

Ministry of Health, Malaysia

University of Malaya

Investigators

• Principal Investigator: Kevin Ng; UMMC

More Information

• Responsible Party: Tan Jenq Uei, Trainee of Master of Anaesthesiology University of Malaya, Ministry of Health, Malaysia
• ClinicalTrials.gov Identifier: NCT03888768
• Other Study ID Numbers: 46050
• First Posted: March 25, 2019
• Last Update Posted: November 1, 2019
• Last Verified: October 2019

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

Keywords provided by Tan Jenq Uei, Ministry of Health, Malaysia:

intravenous iron isomaltoside(monofer); iron deficiency; anaemia; patient blood management

Additional relevant MeSH terms:

Anemia, Iron-Deficiency; Anemia, Hypochromic; Anemia; Hematologic Diseases; Iron Metabolism Disorders; Metabolic Diseases