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临床试验/NCT03745456
NCT03745456Unknown不适用

Hemostasis Profile in Patients With Severe Subarachnoid Hemorrhage

Hospitales Universitarios Virgen del Rocío1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2018年12月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
ROTEM, ROTEM platelet and PFA variations in patients wit SAH.

研究概览

简要总结

Patients with severe subarachnoid hemorrhage (SAH) may present platelet and coagulation dysfunctions immediately after the stroke on admission at the hospital, and persisting up to 3-4 weeks after the onset. This study aimed to investigate the platelet function as assessed by impedance agregometry (ROTEM Platelet) and platelet adhesion (PFA), and the coagulation profile as assessed by ROTEM, over three evolutive times.

详细描述

Patients with severe subarachnoid hemorrhage (SAH) present platelet and coagulation dysfunctions immediately after the stroke, at least two weeks after the onset of SAH. These alterations have been implicated in the presentation of delayed cerebral ischemia (DCI), vasospasm, deep vein thrombosis (DVT) and long-term neurological deterioration. The temporal presentation of the platelet dysfunction and coagulation has not consistently been established, nor have they been assessed with tests for specific platelet receptors. Objective. Primary: To document the platelet function and coagulation, in constant and fixed periods after the stroke onset, in patients with severe SAH, Hunt and Hess 4-5, Fisher 4. Secondary: Relationship between the patterns of hemostasis and coagulation and the presence of vasospasm, DCI and DVT. Method. Prospective, cohort study that will include (calculated sample size) 50 patients with severe SAH, recruited in the first 6 hours after the onset of symptoms. Twenty healthy volunteers (already recruited) will constitute the control group. Platelet function will be studied by platelet count, von Willebrand factor level, platelet function assay (PFA-100), and platelet ROTEM for specific stimulation of platelet receptors (ARATEM, ADPTEM, TRAPTEM). The coagulation will be investigated by conventional coagulation study, ROTEM EXTEM, ROTEM FIBTEM and factor XIII. In the group with SAH, blood samples will be drawn into the first 6 hours after the onset of symptoms (t0), in the period of 8 - 10 days after the stroke (t1) - period of maximum incidence of TBI and DVT - and 14- 16 days after the stroke (t2) in order to evaluate the late degree of coagulation alterations. Baseline values (t0) will be compared between subjects with HSA and the control group (intersubjects comparisons.). On the other hand, significant changes of the hemostasis and coagulation values among the times t0, t1 and t2 in the HAS group, will be also investigated (intra-subjects comparisons). Additionally, the relationship between the hemostasis and coagulation values evaluated at any of the specified time and the clinical outcome, as assessed by the presence of DCI, vasospasm, DVT or neurological deterioration at 3 months of follow-up (mRs> 3), will be also investigated

研究设计

研究类型
Observational
观察模型
Case Only
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

入选标准

  • Consecutive patients with severe subarachnoid hemorrhage (Hunt and Hess 4-5, Fisher 3-4) will be included initially in the first 6 hours after the onset of symptoms.

排除标准

  • Patient with known coagulopathy or with ingestion of antiplatelet drugs or anticoagulants in the 15 days prior to the presentation of symptoms.
  • Patients in whom there is no confirmed arteriovenous malformation.
  • The patient or authorized family member denies informed consent.
  • High risk of imminent death, evaluated by the doctor in charge of the patient.
  • Hemoglobin <100 g / L and / or platelet count <100,000 microL

结局指标

主要结局

ROTEM, ROTEM platelet and PFA variations in patients wit SAH.

时间窗: 1 month.

Document the platelet function (ROTEM platelet and PFA) and coagulation (ROTEM), in constant and fixed periods after the presentation of the stroke, in patients with severe SAH, defined by Hunt and Hess 4-5, Fisher 3-4.

次要结局

  • Secondary outcomes(6 months)

研究者

发起方
Hospitales Universitarios Virgen del Rocío
申办方类型
Other
责任方
Principal Investigator
主要研究者

Santiago R. Leal-Noval

Senior

Hospitales Universitarios Virgen del Rocío

研究点 (1)

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