Hemostasis Profile in Patients With Severe Subarachnoid Hemorrhage

NCT03745456 | Unknown

• 1 other identifier: HUVRocio
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Subarachnoid Hemorrhage; Platelet Dysfunction; Coagulation Disorder

Keywords

Rotational Thromboelstrometry

Outcome Measures

Primary Outcomes (1)

• 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.

  1 month.

Secondary Outcomes (1)

• Secondary outcomes

  6 months

Study Arms (1)

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.

Diagnostic Test: Blood samples for ROTEM and platelet function.

Interventions

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

Subarachnoid Hemorrhage patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospitales Universitarios Virgen del Rocío: lead

Study Sites (1)

Hospital Universitario "Virgen del Rocío"

Seville, 41013, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples for coagulation profile (ROTEM and clotting tests) and platelet function (ROTEM platelet and PFA)

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Hemostatic Disorders

Interventions

Blood Specimen Collection; Platelet Aggregation

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques; Hemorheology; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Platelet Activation; Hemostasis

Study Officials

• Santiago R Leal-Noval, MD

  Medical staff of Neuro Critical Care

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Santiago R leal-Noval, MD

CONTACT

+00 34 955012528; srlealnoval@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 19, 2018
• Study Start: December 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: July 1, 2020
• Last Updated: December 4, 2018

Record last verified: 2018-12

Locations

ES (1)