Nitric Oxide Consumption as a Predictor of Vasospasm in Subarachnoid Hemorrhage
Nitric Oxide Consumption as a Predictor of Vasospasm in Subarachnoid Hemorrhage (SAH): a Prospective Observational Study
연구 개요
상태
상세 설명
After enrollment, the investigators will collect patients' demographics and most relevant clinical characteristics of the patients.
For patients with SAH, the investigators will collect an-1 ml aliquot of CSF from the drainage circuit daily, (using a sterile procedure that involves a valve of the closed system circuit located distally to the patient, before the collection container), for a period of 15 days following SAH. The samples will be stored at -80 degrees.
The investigators will perform daily Transcranial Doppler (TCD) monitoring to assess whether the patients have cerebral vasospasm. In case of suspected vasospasm, and in all comatose patients after 4 days from the bleeding, a CT angiography will be performed to define the angiographic CV.
For the control group, discarded 1 ml-aliquot of CSF will be collected at the time of needle insertion for spinal anesthesia.
At the end of the protocol, the study population will be divided in 3 groups:
- patients with SAH and vasospasm
- patients with SAH and no vasospasm
- control group
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Lorenzo Berra, MD
- 전화번호: 617-726-3030
- 이메일: lberra@mgh.harvard.edu
연구 장소
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Massachusetts
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Boston, Massachusetts, 미국, 02114
- 모병
- Massachusetts General Hospital
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연락하다:
- Lorenzo Berra, MD
- 전화번호: 617-726-3030
- 이메일: lberra@mgh.harvard.edu
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Rome, 이탈리아, 00136
- 모병
- Fondazione Policlinico Universitario Agostino Gemelli
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연락하다:
- Valentina Giammatteo, MD
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Adult
- patient with SAH and with an external ventricular drainage (EVD) placed within 24 hours after the onset of the hemorrhage
Exclusion Criteria:
- pregnancy
- pre-existing neurological comorbidities
- coagulation disorders
- anemia
- absence of a good cranial window to perform Transcranial Doppler (TDC)
- presence of >50% stenosis of carotid arteries confirmed by doppler ultrasound
- Technical problems on EVD that prevent CSF withdrawals
For the control group, we will invite to participate patients without neurological comorbidities undergoing spinal anesthesia in the operating room or with a spinal drain for major vascular surgery.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Aneurysmal subarachnoid hemorrhage
Patients admitted to the Intensive Care Unit following spontaneous aneurysmal subarachnoid hemorrhage
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Control
Patients without neurological comorbidities undergoing spinal anesthesia in the operating room
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Nitric oxide consumption
기간: Daily for 15 days following aneurysmal subarachnoid hemorrhage; for controls, once at initiation of spinal anesthesia
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Measurement taken from cerebrospinal fluid using nitric oxide consumption analyzer
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Daily for 15 days following aneurysmal subarachnoid hemorrhage; for controls, once at initiation of spinal anesthesia
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Occurrence of cerebral vasospasm in patients with subarachnoid hemorrhage
기간: Daily for 15 days following aneurysmal subarachnoid hemorrhage
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Transcranial Doppler monitoring will provide peak systolic velocities (PSVs) at the middle (MCA), anterior (ACA), and posterior (PCA) cerebral arteries.
Suspected vasospasm will be defined as a mean flow velocity >120 cm/s and a Lindegaard ratio (LR) ≥3.
The LR will be obtained by dividing the mean flow velocities of the MCA by those of ipsilateral extracranial internal carotid artery.
In case of suspected vasospasm, and in all comatose patients after 4 days from the bleeding, a CT angiography will be performed to define the angiographic CV.
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Daily for 15 days following aneurysmal subarachnoid hemorrhage
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Nitric oxide metabolite levels
기간: Daily for 15 days following aneurysmal subarachnoid hemorrhage; for controls, once at initiation of spinal anesthesia
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Measurement taken from cerebrospinal fluid
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Daily for 15 days following aneurysmal subarachnoid hemorrhage; for controls, once at initiation of spinal anesthesia
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Free hemoglobin
기간: Daily for 15 days following aneurysmal subarachnoid hemorrhage; for controls, once at initiation of spinal anesthesia
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Measurement taken from cerebrospinal fluid
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Daily for 15 days following aneurysmal subarachnoid hemorrhage; for controls, once at initiation of spinal anesthesia
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공동 작업자 및 조사자
수사관
- 수석 연구원: Lorenzo Berra, MD, Anesthesia, Critical Care and Pain Medicine, Massachusetts General Hospital
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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