Development of a core outcome set for hypertensive intracerebral hemorrhage in clinical trials of traditional Chinese medicine: a study protocol.

BACKGROUND: Intracerebral hemorrhage (ICH) is a devastating disease, its mortality and disability rate are high. In China, hypertensive intracerebral hemorrhage (HICH) is responsible for 75% of all the cases of primary ICH. A lot of randomized controlled trials (RCTs) of traditional Chinese medicine (TCM) for treating HICH have been carried out. However, these RCTs have a lot of problems, such as heterogeneous outcomes, non-uniform point of measurement. These lead to systematic review/meta-analysis only can include a small number of studies. And outcome measures did not take the wishes of patients and other stakeholders into account. The aim of this study is to establish the core outcome set (COS) for future TCM clinical trials of HICH. METHODS AND ANALYSIS: First, we will develop a long list of general outcomes by making systematic literature review and semi-structured interviews. Then healthcare professionals and patients with HICH will be invited to participate in two rounds of the Delphi survey to determine the importance of the outcome. Finally, a face-to-face consensus meeting will be conducted to determine the final COS of HICH, including what outcomes should be measured and when and how to measure the outcomes. RESULTS: We aim to develop a COS that includes TCM core syndrome for HICH to determine what outcomes should be reported and when and how to measure them. CONCLUSION: By doing this, we can increase the reporting consistency and reduce the reporting bias in the outcome, which leads to the reuse of research data in meta-analysis and the making of informed healthcare decisions. ETHICS AND DISSEMINATION: The entire project has received approval from the Ethics Committee of Xiyuan Hospital, China Academy of Chinese Medical Sciences. The final COS will be published and reported at the national and international conferences. TRIAL REGISTRATION: This study is registered with the Core Outcome Measures in Effectiveness Trials database as study 1475 . Registered on December 2019.

Clinical Research of Early Hyperbaric Oxygen Therapy on Patients with Hypertensive Cerebral Hemorrhage After Craniotomy.

AIM: To observe the effect of early hyperbaric oxygen (HBO) therapy on the improvement of consciousness and prognosis of patients with severe brain damages after craniocerebral craniotomy. MATERIAL AND METHODS: Eighty-one patients who had cerebral hemorrhage and underwent clearance of hematoma and decompressive craniectomy from August 2013 to August 2016 were retrospectively analyzed. The patients were divided into HBO and non-HBO therapy groups. The treatment effects were scored and subjected to corresponding statistical analysis. RESULTS: There were significant differences in the Glasgow coma scale (GCS) scores at 3 and 5 weeks (t=2.293 and t=3.014, respectively, p < 0.05), and in Glasgow outcome scale (GOS) scores at 5 weeks and 3 months between the two groups (p < 0.05). CONCLUSION: Early HBO therapy could improve the consciousness and prognosis of patients with cerebral hemorrhage after craniotomy.

Sequential therapy for non-thalamus supratentorial hypertensive intracerebral hemorrhages.

OBJECTIVE: We sought to assess the effectiveness of sequential therapy for non-thalamus supratentorial hypertensive intracerebral hemorrhage (NTS-HICH). PATIENTS AND METHODS: We retrospectively analyzed clinical data of 110 patients with HICH. The patients were admitted 72 hours after disease onset, and 43 patients received sequential therapy. The length of hospital stay, treatment costs, incidence of pulmonary infections, mortality rates and Modified Rankin Score (mRS) 1 and 3 months after NTS-HICH were compared between patients who received sequential or non-sequential therapies. RESULTS: The length of hospital stay, treatment costs, and 1-month mortality rates were not significantly different between both groups. However, mortality rates at 3 months, incidence of pulmonary infection, and mRS at both 1 and 3 months were significantly better in patients who received sequential therapy. CONCLUSIONS: Sequential therapy significantly improves the prognosis for patients with NTS-HICH.

[Diagnostic image (55). Thalamus hemorrhage with intraventricular invasion]. / Diagnose in beeld (55). Thalamusbloeding met ventrikeldoorbraak.

A 54-year-old man presented with headache and cognitive deterioration without other neurological signs, caused by intraventricular, thalamic, and caudate nucleus haemorrhage. He had longstanding hypertension, a known risk factor.