ProPBM : A Modified Patient Blood Management Protocol

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Effect of Combined Iron Protocols on Perioperative Allogeneic Transfusion

NCT06012760

Anemia Iron Deficiency Anemia Perioperative +2 more

RECRUITING NA

Preoperative Intravenous Iron to Treat Anaemia in Major Surgery

NCT01692418

Anaemia

COMPLETED PHASE3

Patient Blood Management in the Approach to Prosthetic Surgery [PBM(L4178)]

NCT05806437

Anemia, Iron Deficiency

RECRUITING NA

Patient Blood Management in Cardiac Surgery

NCT04040023

Surgical Blood Loss

COMPLETED NA

Active Preoperative Anemia Management in Patients Undergoing Cardiac Surgery

NCT02189889

Anemia Cardiovascular Disease

TERMINATED PHASE1/PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Iron-deficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

ProPBM arm and standard Care arm

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

patient will be randomised into ProPBM and standard care arm

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type ACTIVE_COMPARATOR

MonoFer

Intervention Type DRUG

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

Standard Care

patient will received standard hospital practise

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MonoFer

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

isomaltoside

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes