About this trial
Brief Summary of the Study The goal of this observational study is to assess the incidence of vitamin C deficiency among hospitalized adults presenting with hemorrhagic signs. The study will also evaluate the effectiveness of a standardized screening protocol compared to traditional clinical judgment.
The main questions it aims to answer are:
What is the incidence of vitamin C deficiency in hospitalized patients with hemorrhagic symptoms? Is a standardized screening protocol more effective than traditional clinical judgment in identifying vitamin C deficiency? Is vitamin C deficiency associated with anemia, other micronutrient deficiencies (folate, B12, albumin, iron), or infectious conditions? Does vitamin C deficiency impact hospital length of stay? Researchers will compare a systematic screening approach based on predefined hemorrhagic criteria (e.g., hematuria, ecchymosis, epistaxis, petechiae, gastrointestinal bleeding, or intracranial hemorrhage) to the traditional physician-judgment approach to determine its effectiveness in identifying vitamin C deficiency.
Study Design
Participants will:
Be hospitalized adults (≥18 years old) presenting with documented micro- or macroscopic hemorrhagic signs.
Undergo vitamin C level assessment either as part of the standardized screening protocol (prospective arm) or based on physician judgment (retrospective control group).
Have additional clinical and laboratory data collected, including hemoglobin levels, platelet count, iron status, vitamin B9/B12 levels, and other relevant parameters.
This non-interventional study will not modify the standard of care but will systematically assess the prevalence of vitamin C deficiency in at-risk patients and evaluate the utility of a structured screening protocol.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
Patients who received Vitamin C supplementation within the month prior to testing. Incomplete or missing medical records regarding hemorrhagic manifestations or Vitamin C test results. Hemorrhagic events clearly attributable to anticoagulant or antiplatelet overdose, without other potential contributing factors. Blood samples processed more than 2 hours after collection, making Vitamin C levels unreliable.
Trial design
Other
Other
Treatments tested in this trial
systematical screening of at risk patients based on predefined hemorrhagic criteria
Diagnostic testPatients selected if condition present: Hematuria (blood in urine) Macroscopic hematuria (visible blood in urine) Hematuria detected by urine dipstick or microscopic analysis Ecchymoses (bruising) Epistaxis (nosebleeds) Petechiae (small pinpoint hemorrhages on the skin) Gastrointestinal bleeding Upper GI bleeding: Hematemesis (vomiting blood) Lower GI bleeding: Melena (black tarry stools) Positive fecal occult blood test (FOBT) Cerebral hemorrhage (brain bleeding)
Treatment groups
Trial outcomes
Primary outcomes
The primary outcome of the study is the existence of Vitamin C deficiency in hospitalized patients presenting with hemorrhagic signs.
Definition of the Primary Outcome: Vitamin C deficiency will be determined based on serum ascorbic acid levels measured through blood sampling. A deficient status is defined as a serum ascorbic acid concentration below the reference values established by the central laboratory (Cerba, Paris, France). Only samples processed within 2 hours of collection will be considered valid due to the instability of ascorbic acid.
Sponsors and contacts
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Internist.Ro
Lead sponsor
Centre Hospital Regional Universitaire de Limoges
Collaborator
This trial is not recruiting at the moment. You can still explore other options: