Etiology and Prognostic Risk Factors of Intracerebral Hemorrhage in Beijing

• Conditions: Intracerebral Hemorrhage

• Registration Number: NCT02350010
• Lead Sponsor: Beijing Neurosurgical Institute

Brief Summary

There were lack of data and analysis about medical management, etiology, and long-term outcome of Intracerebral Hemorrhage (ICH) in Beijing. In this study the investigators do acute CT angiography, a non-invasive imaging method to explore etiology and prognostic risk factors of ICH. Further the investigators will aim to develop and validate a risk score for predicting 1-year functional outcome after ICH.

Detailed Description

Intracerebral hemorrhage (ICH) accounts for 10 %-15 % of all strokes and is one of leading causes of stroke related mortality and morbidity worldwide. Despite advances in medical knowledge, treatment for ICH remains strictly supportive. ICH accounted for 26.7～51.5% of stroke in China, the proportion was higher than in Western countries. There were lack of data and analysis about medical management, etiology, and long-term outcome of ICH in Beijing.

In this study we do acute CT angiography (CTA), a non-invasive imaging method to explore etiology and prognostic risk factors of ICH. Further we will aim to develop and validate a risk score for predicting 1-year functional outcome after ICH. There are some studies of CTA to assess the cause of ICH and functional outcomes, but lack of multi-center, large sample studies to support and validate these findings, particularly fewer application of postcontrast CT. This would allow an early intervention base on different causes and Select treatment decisions according to risk score.

We are planning to:

When patients with ICH arrive in stroke department of the topic cooperation hospitals within 72 hours after symptom onset, they will be subject to CTA with the protocoled sequences.

Standard sequences: Pre- and postcontrast head imaging is acquired from the skull base to vertex with parameters: 120 kVp; 340 mA; 4x5 mm collimation; 1second/rotation; and a table speed of 15 mm/rotation. CTA was performed immediately after initial noncontrast CT(NCCT) performance using a bolus-tracking method by injecting 90 mL of nonionic iodinated contrast (OPTIRAY 350) at 5 mL/s. The protocol for the circle of Willis was 120 kVp, 360 mAs, 0.5 second/rotation, 0.75 mm thick with a pitch of 0.65. Postprocessing procedure including multiplanar reconstruction was performed by a CT technologist at the CT operator's discretion for assessment of contrast extravagation and etiologies of ICH such as vascular malformation, and venous sinus thrombosis. Coronal and sagittal multiplanar reconstructed images were created as 10.0-mm-thick images spaced by 3 mm. Axial reformed images were 4 mm thick with 2-mm spacing.

Clinical data of patients with ICH will be collected by 2 neurologists blinded to the radiological data during patients' hospitalization and at the 3-month, 6-month, and 1-year follow-up. The collected demographic and clinical variables included gender, age, body mass index, alcohol and tobacco use, history of hypertension, diabetes, hyperlipidemia, stroke, coronary heart disease, and medications (antihypertensive, antiplatelet, and anticoagulation agents). The systolic and diastolic blood pressure of patients will be recorded. Stroke severity on admission will be evaluated by Glasgow Coma Scale and National Institutes of Health Stroke Scale. Laboratory tests on admission included white blood cell count, hemoglobin, platelet count, serum glucose, serum creatinine, fibrinogen, activated partial thromboplastin time, and prothrombin time as expressed by the international normalized ratio. Length of hospital stay was recorded. The patients' clinical outcome will be assessed by modified Rankin Scale on discharge and 30-day, 3-month, 6-month, and 1-year.

To sum up the purpose of this present study is to explore etiology and prognostic risk factors of ICH by acute CTA and develop and validate a risk score for predicting 1-year functional outcome after ICH.

Study Timeline

• Status Verified: 2015-01
• Study Start: 2015-01
• Study First Submitted: 2015-01-07
• Study First Submitted QC: 2015-01-26
• Last Update Submitted: 2015-01-26
• Study First Posted: 2015-01-29
• Last Update Posted: 2015-01-29
• Primary Completion: 2016-03
• Study Completion: 2017-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

• CT demonstrated ICH
• Age above 18
• within 72 hours of symptom onset
• Informed consent from patient or proxy

Exclusion Criteria

allergy to contrast medium incompletion of a standard CT protocol including noncontrast CT (NCCT) and CTA Lack of informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
one-year functional outcome and mortality of Intracerebral hemorrhage.	one year	Good functional outcome was defined as modified Rankin Scale score (mRS) ≤2.

Trial Locations

Locations (1)

Beijing Neurosurgical Institute; 🇨🇳 Beijing, Beijing, China