Prevention and Treatment for Bruises in Patients with Ischemic Stroke
Status:
NOT_YET_RECRUITING
Trial end date:
2028-07-31
Target enrollment:
Participant gender:
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.