ProPBM : A Modified Patient Blood Management Protocol

Iron-deficiency Clinical Trial

Official title:

ProPBM : A Randomised Control Trial Comparing a Modified Patient Blood Management Protocol Against Standard Care for Patients Undergoing Major Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03888768
• Other study ID #: 46050
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: December 2021

Study information

• Verified date: October 2019
• Source: Ministry of Health, Malaysia
• Contact: Jenq Uei Tan
• Phone: +60165213692
• Email: jenquei84[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 2021
• Est. primary completion date: October 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anemia, Iron-Deficiency
• Iron-deficiency

Intervention

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

Locations

Country	Name	City	State
Malaysia	University Malaya Medical Centre, Jalan Universiti	Kuala Lumpur	Wilayah Persekutuan Kuala Lumpur

Sponsors (2)

Lead Sponsor	Collaborator
Ministry of Health, Malaysia	University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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