Prevention and Treatment for Bruises in Patients with Ischemic Stroke

NCT06823999 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: IRB2024099
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background Over the past few decades, significant advances have been made in the diagnosis and treatment of strokes. Most studies focus on functional recovery in stroke patients. In addition to motor function, there are many symptoms may affect function and quality of life in stroke patients. Bruises are caused by damage to the skin that causes blood to drain out of the capillaries and accumulate in the connective tissue of the skin or subcutaneous tissue. The study on non-motor syndrome in ischemic stroke patients found that 25.8% of ischemic stroke patients had bruises and 17.7% of bruises were unexplained bruises. In addition to the physiological and emotional effects on stroke patients, bruises may increase infection risk and affect stroke patient outcomes. Vitamin C is a natural antioxidant discovered in 1747 to treat and prevent scurvy. Vitamin C can reduce gum bleeding and prevent colon bleeding after a polypectomy. Vitamin C has been reported to reduce brain edema around brain injury and decrease mortality in patients with traumatic brain injury. Dehydroascorbic acid decreases infarct volume in mice with middle cerebral artery occlusion. Investigators hypothesized that administration of vitamin C to patients with acute ischemic stroke patients would decrease the risk of bleeding and enhance its resolution. Investigators also hypothesized that vitamin C injection could minimize infarct volume and improve outcomes in ischemic stroke patients. The aims of the study include: 1. To investigate whether vitamin C injections can reduce bruising risk and enhance bruising resolution. 2. To explore whether vitamin C injections in the acute phase of stroke can improve the prognosis of ischemic stroke patients. Methods This is a prospective, double-blind, randomized controlled study. All patients admitted to the hospital under the diagnosis of ischemic stroke and stroke was confirmed by Magnetic Resonance imaging (MRI) or brain computed imaging (CT) and aged between 20 and 85 years were invited to participate in the study. Investigators excluded patients who had these diseases: cancer receiving chemotherapy, end stage renal disease receiving dialysis, autoimmune disease, hematological disease, Glucose-6-phosphatase disease, gouty arthritis, and a lack of informed consent. During the study period, all patients who met the inclusion and exclusion criteria were invited to participate in the study. After informed consent, participants were randomly assigned to the experimental group or the control group. All participants underwent NIHSS evaluation and a detailed dermatological examination on the day of hospitalization. After enrollment, the experimental group received 4 mg Vitamin C injection per day for 4 days, while the control group received the same volume of normal saline injection per day for 4 days. Researchers evaluate participant skin condition (including bruises number and size, color) every day during hospitalization, and up to 1 month after stroke. Investigators evaluate NIHSS at discharge and follow-up functional outcome (mRS) up to 3 months after stroke onset. Analysis Rate shows bruise percentage. Chi square or Fisher exact test was applied to compare the difference in bruises between two groups. Logistic regression was used to compare bruise risk between groups. Wilcoxon rank sign test was used to analyze stroke severity and outcome between two groups.

Conditions

Stroke; Bruises; Skin Lesions

Keywords

stroke; bruises; skin lesions; vitamin C; bleeding

Outcome Measures

Primary Outcomes (1)

• 1. The rate of hematoma occurrence (in any location). 2. Comparison of hematoma resolution rates, using a benchmark of a reduction in hematoma area greater than 30%. This applies to both pre-existing and newly developed hematomas.

  The study will begin at Auguest 1, 2025, we evaluate patients skin condition everyday and analysis the results at August 2027.

Study Arms (2)

stroke

EXPERIMENTAL

Drug: Ascorbic acid (Vitamin C)

Control

PLACEBO COMPARATOR

Participants receiving normal saline 20 ml infusion perday for 4 days

Other: Normal Saline (Placebo)

Interventions

Ascorbic acid (Vitamin C) DRUG

In the study, acute ischemic stroke patients will receiving vitamin C 4 gram perday for 4 days.

stroke

Normal Saline (Placebo) OTHER

Particiapnts receiving normal saline 20 ml perday for 4 days

Control

Eligibility Criteria

• Age: 20 Years - 85 Years
• Gender Eligibility Details: No special selection.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ischemic stroke patients.
• Aged 20 to 85 years.

You may not qualify if:

• o Cancer patients undergoing chemotherapy.
• End-stage renal disease patients receiving hemodialysis.
• Patients undergoing immunosuppressive therapy.
• Patients with coagulation disorders.
• Patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency (favism).
• Patients with thalassemia.
• Patients who did not sign the consent form.

Sponsors & Collaborators

• Chiayi Christian Hospital: lead

Related Publications (31)

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MeSH Terms

Conditions

Stroke; Contusions; Hemorrhage

Interventions

Ascorbic Acid; Saline Solution

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Wounds, Nonpenetrating; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Central Study Contacts

Cheung-Ter Ong, Master

CONTACT

+886-2765041-7283; 01288@cych.org.tw

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2025
• First Posted: February 13, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share