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VITAL: VITamin E and Anaemia in dialysis patients in Leeds

A study to assess the effects of a vitamin E bonded haemodialysis membrane on erythropoiesis simulating agent requirements and fibrin clot structure and function in chronic haemodialysis patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12650766
Enrollment
348
Registered
2010-04-23
Start date
2009-10-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Renal and Urogenital

Interventions

Control: Rexeed Dialyser Intervention: Vitabran E dialyser Follow Up Length: 12 month(s)

Sponsors

Leeds Teaching Hospitals NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Dialysis patient managed by Leeds Teaching Hospitals NHS Trust Renal Unit 2. Established on HD for at least 3 months prior to entry into study 3. Patients expected to remain on haemodialysis for at least 6 months 4. Written consent and willingness to participate in the study 5. Aged greater than 18 years at point of entry into study 6. Patients on a 3 times a week dialysis schedule

Exclusion criteria

Exclusion criteria: 1. Unwillingness or inability to cooperate or give written informed consent 2. Terminally ill patients (expected survival less than 6 months) 3. Medical conditions requiring regular blood transfusion at the time of study enrolment 4. Any serious medical, social or psychological condition that in the opinion of the investigator would disqualify from participation 5. Patients with a significant inflammatory illness within 3 months as defined by a C-reactive protein (CRP) greater than 50 mg/L or 3 x patient's baseline CRP

Design outcomes

Primary

MeasureTime frame
Haemoglobin concentration and erythropoeisis stimulating agent requirements at 6 months and 12 months

Secondary

MeasureTime frame
Data collected at 6 and 12 months on: 1. Markers of oxidative stress 2. Fibrin clot structure

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026