Subarachnoid HemorrhageNCT03745456
Hemostasis Profile in Patients With Severe Subarachnoid Hemorrhage
An observational study of Subarachnoid Hemorrhage and Platelet Dysfunction, run by Hospitales Universitarios Virgen del Rocío at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage, Platelet Dysfunction, Coagulation Disorder
- What is being tested?
- Blood samples for ROTEM and platelet function.
- How many people
- 50 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2018to 1 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Being tested
- Blood samples for ROTEM and platelet function.
- Keywords
- Rotational Thromboelstrometry
- Medical subject headings
- Subarachnoid Hemorrhage, Hemostatic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples for ROTEM and platelet function.Diagnostic test
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Blood samples for ROTEM and platelet function. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ROTEM, ROTEM platelet and PFA variations in patients wit SAH.
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.
Measured: 1 month.
Secondary outcomes (1)
Secondary outcomes
Relationship between hemostasis and coagulation patterns and the presence of vasospasm, Late Cerebral Ischemia and Deep Venous Thrombosis
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start1 Dec 2018 (estimated)
- Primary completion1 Dec 2019 (estimated)
- Study completion1 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospitales Universitarios Virgen del Rocío
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Santiago R. Leal-Noval, Hospitales Universitarios Virgen del Rocío
- Investigators
- Santiago R Leal-Noval, MD, Principal investigator, Medical staff of Neuro Critical Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03745456
- Sponsor's protocol ID
- HUVRocio
- Status last verified
- Dec 2018
- First submitted
- 15 Nov 2018
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemostasis Profile in Patients With Severe Subarachnoid Hemorrhage
- ClinicalTrials.gov ID
- NCT03745456
- Acronym / sponsor ID
- HUVRocio
- Keywords
- Rotational Thromboelstrometry
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospitales Universitarios Virgen del RocíoUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 1 Jul 2020 (estimated)
- First posted
- 19 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subarachnoid Hemorrhage patients | – | Diagnostic Test: Blood samples for ROTEM and platelet function.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples for ROTEM and platelet function.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 | Diagnostic test | Subarachnoid Hemorrhage patients |
Primary outcome
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 secondary outcome
Secondary outcomes
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Santiago R Leal-Noval, MD principal investigator
Medical staff of Neuro Critical Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subarachnoid Hemorrhage and Platelet Dysfunction, run by Hospitales Universitarios Virgen del Rocío at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Santiago R leal-Noval, MD (+00 34 955012528 ext. 312528, srlealnoval@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ROTEM, ROTEM platelet and PFA variations in patients wit SAH. (time frame: 1 month.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2018.