Ignite Creation Date:
2025-12-24 @ 5:55 PM
Ignite Modification Date:
2025-12-24 @ 5:55 PM
Study NCT ID:
NCT03888768
Status:
UNKNOWN
Last Update Posted:
2019-11-01
First Post:
2019-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ProPBM : A Modified Patient Blood Management Protocol
Sponsor:
Ministry of Health, Malaysia
Organization:
Study Overview
Official Title:
ProPBM : A Randomised Control Trial Comparing a Modified Patient Blood Management Protocol Against Standard Care for Patients Undergoing Major Surgery
Status:
UNKNOWN
Status Verified Date:
2019-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: