Association Between Anaemia and Handgrip Strength in Female Planned for Major Surgery and the Effect of Intravenous Iron on Handgrip Strength

University of Malaya

Status: Unknown

Conditions: Iron Deficiency Anemia; Patient Blood Management; Anemia; Iron-deficiency

Treatments: Device: Jamar hydraulic hand dynamometer

Study type: Observational

Funder types: Other

Identifiers

NCT04642521

Anaemiahandgrip

Details and patient eligibility

About

This is a sub-study parallel to ProPBM : A Randomised Control Trial Comparing a Modified Patient Blood Management Protocol Against Standard Care for Patients Undergoing Major Surgery (NCT03888768).

Only female participants of ProPBM will be included in this sub-study.

Association between anaemia and handgrip strength and the effect of intravenous iron therapy as part of ProPBM protocol within female participants is elucidated in this study.

Full description

BACKGROUND:

Maximal physical efforts and aerobic exercise depend highly on adequate oxygen supply provided by haemoglobin and level of iron bound to haemoglobin.

Handgrip strength has been shown to have a strong validity and high reliability in testing the upper body and lower body muscle strength, however its use as a potential tool to identify early anaemic patients planned for surgery is not fully explored. To our knowledge, this study is the first to investigate the diagnostic power of functional performance test within preoperative anaemic population and the change of handgrip strength after administration of intravenous iron.

METHODS:

At recruitment of ProPBM study, all eligible patients for this sub-study will be invited to this sub-study and have their full blood count, ferritin and transferrin saturation recorded and handgrip strength assessed.

After randomization, those within the ProPBM protocol will receive IV iron therapy as indicated. Participants who are randomized to standard care will follow usual medical management.

Participants will be admitted 1 day prior to surgery. On admission, preoperative bloods and handgrip strength will be repeated for patients who were randomized into the ProPBM arm.

Enrollment: 65 estimated patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Female patients participating in the ProPBM study
• Undergoing major surgery in gynaecology, gastrointestinal surgery and orthopaedics surgery
• The patient must be willing and able to provide informed consent for the study

Exclusion criteria

• Patients with known muscle weakness eg myasthenia gravis
• Patients with cerebrovascular or orthopaedic disease that could influence muscle mass and/or upper body function
• Patients in which IV iron is contraindicated eg 1st trimester of pregnancy or known allergy or hypersensitivity to parenteral iron
• Patients with iron overload

Trial design

65 participants in 2 patient groups

Iron deficiency anaemia

Description:

Preoperatively, participants who are iron deficient with or without anaemia will receive intravenous iron (Monofer) as per ProPBM protocol.

Treatment:

Device: Jamar hydraulic hand dynamometer

No iron deficiency anaemia

Description:

Patient in this group will not be given intravenous iron.

Treatment:

Device: Jamar hydraulic hand dynamometer