Adult patients undergoing elective surgery
Having a CPET as part of routine care
Patients with a Hb value of < 130 g/L who are iron deficient, iron restricted/deplete or have functional iron deficiency.
Able to provide written informed consent.

Plasma stored in freezers at University Hospital Southampton

Anemia

Anemia, Iron Deficiency

Anaemic patients undergoing major surgery who would routinely be receiving intravenous iron 'MonoFer' will get this as part of routine care. They will then have a CPET repeated at least 10 days afterwards.

MonoFer

University Hospital Southampton NHS Foundation trust

CArdio PulmOnary Exercise Testing and IntRAvenous Iron- 'CAPOEIRA-I STUDY'

Cardiopulmonary Exercise Testing Before and After Intravenous Iron: a Prospective Clinical Study

Using cardiopulmonary exercise testing (CPET) to assess the oxygen consumption at anaerobic threshold before and then after intravenous iron therapy.

Using cardiopulmonary exercise testing (CPET) to assess the oxygen consumption at peak exercise before and then after intravenous iron therapy therapy

Laboratory measured haemoglobin concentration

By using the optimised carbon monoxide rebreathing technique (oCOR) total haemoglobin mass will be measured before intravenous iron therapy and then again after intravenous iron therapy

Hepcidin is iron regulatory hormone produced in the liver that affects iron transport. This will be measured twice.

Ferritin is an acute phase protein but it is also the body major storage protein for iron.

Plasma marker of iron storage and availability.

Hospital length of stay after to include entire perioperative stay. (This is routinely collected already as part of the preoperative optimisation of anaemia before surgery (POAS) service.)

Additional blood tests taken as part of the volume descriptive biomarker panel.

Data will not be shared outside of the study team

University Hospital Southampton NHS Foundation Trust

University College, London

University of Bayreuth

The Haptoglobin 2-2 group randomised to Vitamin E

The Haptoglobin 2-2 group randomised to placebo

The Non Haptoglobin 2-2 group randomised to Vitamin E

The Non Haptoglobin 2-2 group randomised to placebo

Diabetes Mellitus

Two hundred patients will be recruited to a pilot randomized controlled trial (RCT), stratified by Hp 2-2 phenotype status (100 Hp 2-2 and 100 non-Hp 2-2), and randomly allocated in a 1:1 ratio to either vitamin E 400 IU supplementation daily for 6 months or a placebo group. The trial will determine whether vitamin E improves the aforementioned surrogate markers in the Hp phenotype strata.

Vitamin E

Placebo

Tan Tock Seng Hospital

Relationship of Haptoglobin Phenotype to Vascular Function and Response to Vitamin E Supplementation in Patients With Diabetes Mellitus Type 2: The EVAS Trial

Measured as Reactive hyperemia index using RHI-EndoPAT

Measured as pulse wave velocity using the sphygmocor device

Measured as ratio between retinal arterial diameter and venous diameter as retinal AV index

Lee Kong Chian School of Medicine, Nanyang Technological University

National Medical Research Council (NMRC), Singapore

Patients switch from taking warfarin in the evening to taking warfarin in the morning.

Patients continue taking warfarin in the evening as per their usual routine.

Atrial Fibrillation

Thrombus Due to Heart Valve Prosthesis

Deep Venous Thrombosis

Thromboembolism

Warfarin

University of Alberta

Vancouver Coastal Health Research Institute

The Effect of Medication Timing on Anticoagulation Stability in Users of Warfarin: The "INRange" RCT

Our primary outcome, percentage change in time spent OUTSIDE of therapeutic range is chosen because we believe this is a measure more likely to be shared by patients across a wide range of TTR (i.e. a patient with high baseline TTR and a patient with low baseline TTR may still share a similar % change in time outside of therapeutic range as a response to our intervention). This would not be true for change in TTR itself. It is also the time spent outside of range which contributes more directly to risk of thrombosis and hemorrhage and hence the change in this measure is more clinically meaningful than the change in TTR itself.

The percentage of patients with TTR > 75% provides the percentage of patients considered to have excellent control.

The percentage of patients with TTR < 60% provides the percentage of patients for whom other anticoagulation strategies may be indicated.

Includes all-cause mortality, hospitalization for stroke, hospitalization for GI bleeding, and deep venous thrombosis / pulmonary embolism.

For those patients with at least one INR value above the therapeutic range, the maximum INR observed.

For those patients with at least one INR value below the therapeutic range, the minimum INR value observed.

Includes non-hemorrhagic stroke, deep vein thrombosis, pulmonary embolus and acute arterial occlusion

Includes all bleeding events requiring hospitalization such as hemorrhagic stroke and GI bleeding

Patient self-reports of adherence to their allocated intervention during telephone follow-up occurring at 1 week, 1 month and upon study completion

Upon publication of all planned manuscripts stemming from this work, anonymized patient level trial data will be posted on www.PragmaticTrials.ca

spinacia oleracea/hémorragie

CArdio PulmOnary Exercise Testing and IntRAvenous Iron- 'CAPOEIRA-I STUDY'

Relationship of Haptoglobin Phenotype to Vascular Function and Response to Vitamin E Supplementation in Patients With Diabetes Mellitus Type 2: The EVAS Trial

The Effect of Medication Timing on Anticoagulation Stability in Users of Warfarin: The "INRange" RCT

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