Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07352358
Brief Summary:
A total of 72 patients meeting the diagnostic criteria for acute cerebral venous thrombosis were included in this study. A multi-center stratified randomization method was adopted, with the stratification factor being each participating center. There were three groups in total, and within each group, the experimental group and the control group were assigned in a 1:1 ratio. Finally, all the experimental groups and control groups were combined to form the overall experimental group and control group. Random sequences were generated using a computer random number generator, and concealed allocation was implemented using sealed, opaque, consecutively numbered envelopes. Patients and their families, researchers, treating physicians and nurses, outcome assessors, and other personnel directly involved in the trial were unaware of the treatment allocation. Patients meeting the inclusion criteria for acute CVT were immediately given standard anticoagulant therapy (subcutaneous injection of low-molecular-weight heparin at a dose of 0.4 mg every 12 hours for 5-7 days). Subsequently, patients were randomly assigned to the experimental group and the control group. The experimental group received a combination of anticoagulants (low-molecular-weight heparin bridged to warfarin 3 mg/day, rivaroxaban 10-20 mg/day, or dabigatran 110-150 mg twice daily) and batroxobin (initial dose of 10 BU, followed by 5 BU every other day); the control group received only the aforementioned anticoagulants. Follow-up evaluations were conducted at 7 days, 30 days, and 90 days after baseline. Baseline data included demographic characteristics, routine laboratory tests (complete blood count, liver and kidney function tests, electrolyte analysis, urine analysis, and coagulation function), TOF MRV, NIHSS score, and mRS score. Follow-up data covered TOF MRV, NIHSS score, and mRS score at 7 days, 30 ± 7 days, and 90 ± 7 days for the treatment groups. NIHSS and mRS assessments were conducted by neurologists who were unaware of the treatment plan. To minimize potential bias in the primary outcome, qualified personnel at each research center reviewed the 90-day clinical evaluations according to a standardized procedure manual. To ensure the validity and reproducibility of the evaluations, training courses were held for all researchers at each center. In addition, researchers recorded in detail the concomitant medications and adverse events that occurred within 90 days after patient enrollment. The primary endpoint was the proportion of patients achieving recanalization within 7 days of treatment. Secondary endpoints included the proportion of patients achieving neurological improvement (NIHSS score reduction ≥ 2 points) or deterioration (NIHSS score increase ≥ 4 points) at 7 days, 30 days, and 90 days, the proportion of patients achieving functional improvement (mRS score reduction) within 90 days, and the occurrence of CVT recurrence or other vascular events within 90 days.
Study:
NCT07352358
Study Brief:
Protocol Section:
NCT07352358