- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03745456
Hemostasis Profile in Patients With Severe Subarachnoid Hemorrhage
December 3, 2018 updated by: Santiago R. Leal-Noval, Hospitales Universitarios Virgen del Rocío
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.
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
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
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Santiago R leal-Noval, MD
- Phone Number: 312528 +00 34 955012528
- Email: srlealnoval@gmail.com
Study Locations
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-
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Seville, Spain, 41013
- Hospital Universitario "Virgen del Rocío"
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients with severe subarachnoid hemorrhage (Hunt and Hess 4-5, Fisher 3-4) in the first 6 hours after the onset of symptoms
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Subarachnoid Hemorrhage patients
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.
|
Thormoboelastometry is based on the measurement of elasticity of blood by continuous graphical logging of the firmness of a blood clot during clot formation and subsequent fibrinolysis
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ROTEM, ROTEM platelet and PFA variations in patients wit SAH.
Time Frame: 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.
|
1 month.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary outcomes
Time Frame: 6 months
|
Relationship between hemostasis and coagulation patterns and the presence of vasospasm, Late Cerebral Ischemia and Deep Venous Thrombosis
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Santiago R Leal-Noval, MD, Medical staff of Neuro Critical Care
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
December 1, 2018
Primary Completion (ANTICIPATED)
December 1, 2019
Study Completion (ANTICIPATED)
July 1, 2020
Study Registration Dates
First Submitted
November 15, 2018
First Submitted That Met QC Criteria
November 15, 2018
First Posted (ACTUAL)
November 19, 2018
Study Record Updates
Last Update Posted (ACTUAL)
December 4, 2018
Last Update Submitted That Met QC Criteria
December 3, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Hematologic Diseases
- Hemorrhagic Disorders
- Intracranial Hemorrhages
- Hemostatic Disorders
- Blood Coagulation Disorders
- Hemorrhage
- Subarachnoid Hemorrhage
Other Study ID Numbers
- HUVRocio
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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