NCT07231315尚未招募不适用
INTEnsive Ambulance-delivered Blood Pressure Reduction in Biomarker-identified Hyper-ACute Intracerebral Haemorrhage Trial - Validation Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 465
- 试验地点
- 4
- 主要终点
- Proportion of participants without ICH on hospital-based brain CT who are correctly identified as negative based on GFAP point-of-care measurement. (Specificity)
研究概览
简要总结
As an investigator-initiated and conducted, multi-centre, open-label, single-arm prospective observational trial, INTERACT4 Expansion aims to evaluate the diagnostic accuracy of GFAP measured using a point-of-care device, for identifying ICH in participants presenting with acute stroke-like symptoms in the pre-hospital setting compared with imaging-confirmed ICH.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (age ≥18 years);
- •Acute syndrome that is due to presumed acute stroke, defined as FAST (Face, Arm, Speech, Time) scores of ≥2 with an arm motor deficit;
- •Time ≤3 hours from last seen well;
- •Systolic BP (SBP) ≥150mmHg.
排除标准
- •Participants in coma (no response to tactile/verbal stimulation); or/and do not respond to "P" or "U" on the alert/verbal/painful/unresponsive (APVU) responsiveness scale;
- •Severe known co-morbid disease (e.g. cancer, chronic airflow disease, severe dementia, severe heart failure, pre-existing disability [needing help]);
- •Known history of epilepsy or seizure at onset;
- •Recent head injury (where there is potential for another type of intracranial haemorrhage or head trauma);
- •Hypoglycaemia (glucose<4.0 mmol/L) as measured in the ambulance.
结局指标
主要结局
Proportion of participants without ICH on hospital-based brain CT who are correctly identified as negative based on GFAP point-of-care measurement. (Specificity)
时间窗: From enrolment to initial CT scan up until 7 day assessment
次要结局
- Proportion of participants with ICH on hospital-based brain CT who are correctly identified as positive based on GFAP point-of-care measurement.(From enrolment to initial CT scan up until 7 day assessment)
- Proportion of participants with a positive GFAP point-of-care measurement who are confirmed to have ICH on hospital-based brain CT.(From enrolment to initial CT scan up until 7 day assessment)
- Proportion of participants with a negative GFAP point-of-care measurement who are confirmed to not have an ICH on hospital-based brain CT.(From enrolment to initial CT scan up until 7 day assessment)
- Feasibility of recruitment, assessed by the proportion of enrolled participants over the number of stroke calls in the participating networks during the study period.(From enrollment to end of the study.)
- Feasibility of protocol delivery, assessed by the proportion of participants for whom all required study assessments in the ambulance were completed among those in whom assessments were initiated.(From enrolment to transfer to hospital at day 1)
- Feasibility of GFAP testing in the prehospital setting, defined as the proportion of enrolled participants in whom GFAP testing was successfully completed using the point-of-care device in the ambulance.(From enrolment to transfer to hospital at day 1)
- Correlation of GFAP measurement by the point-of-care device against a laboratory assay.(From enrolment to transfer to hospital at day 1)
研究者
研究点 (4)
Loading locations...
相似试验
已完成
3 期
Intensive Ambulance-delivered Blood Pressure Reduction in Hyper-Acute Stroke TrialStroke, AcuteCerebrovascular DisordersNCT03790800The George Institute for Global Health, China2,425
已完成
3 期
Furosemide and Albumin for Diuresis of Edema: A Pilot Randomized Controlled TrialEdemaHypoproteinemiaNCT02055872Hamilton Health Sciences Corporation46
已完成
4 期
Valsartan Intensified Primary Care Reduction of Blood Pressure StudyHypertensionNCT00902304Novartis Pharmaceuticals2,337
终止
不适用
Intensive Control of Blood Pressure in Acute Ischemic Stroke After Endovascular Therapy on Clinical Outcome (CRISIS I)Acute Ischemic StrokeNCT04775147Nanjing First Hospital, Nanjing Medical University205
终止
4 期
A Safety and Efficacy Study of Blood Pressure Control in Acute Aortic Emergencies - A Pilot Study (PROMPT)Aortic DiseaseAortic AneurysmNCT01033370Asma Zainab, M.D.5