Prospective Analysis of the Use of TEG in Stroke Patients

NCT02494726 | Completed DMC

• 1 other identifier: MS-09-0156
• Study Type: observational
• Target: 178
• Locations: 1 country
• Sites: 1

Brief Summary

The overall purpose of this study is to evaluate how effective Thromboelastography (TEG) is on identifying ischemic and hemorrhagic stroke patients at increased risk for bleeding after receiving tissue plasminogen activator (tPA), as well as on differentiating between patients in whom optimal thrombolysis has been achieved, and those whom it has not.

Conditions

Ischemic Stroke; Brain Hemorrhage

Keywords

Ischemic stroke; ICH stroke; TEG; Thromboelastography; Stroke

Outcome Measures

Primary Outcomes (1)

• Baseline TEG in patients with spontaneous ICH vs age matched controls

  Compare baseline (within 6 hours of last seen normal) TEG in patients with spontaneous ICH to TEG in age-matched controls.

  TEG obtained within 6 hours of last seen normal in patients with spontaneous ICH

Secondary Outcomes (1)

• Rapid clinical improvement after tPA (8 or greater point improvement on NIHSS score or total NIHSS 0 or 1)

  Change in NIHSS score from baseline (prior to IV tPA within 4.5 hours of last seen normal) to NIHSS 36 +/- 12 hours after last seen normal.

Other Outcomes (4)

• Hematoma enlargement in patients with spontaneous ICH

  CT hematoma volume at 36 +/- 12 hours compared to baseline (within 6 hours of last seen normal)

• Hemorrhagic transformation after IV tPA

  Any bleeding on post tPA imaging 36 hours +/- 12 hrs after stroke onset

• Arterial recanalization after IV tPA

  Recanalization (TICI 2b or 3 flow) on imaging within 36 hours post IV tPA compared to pre-treatment

Study Arms (3)

Ischemic Stroke

Ischemic stroke patients who have had blood analyzed using thromboelastography (TEG)

Other: Thromboelastography

Healthy Controls

Healthy controls who have had their blood analyzed using thromboelastography (TEG)

Other: Thromboelastography

Hemorrhagic Stroke

Intracerebral hemorrhage patients who have had their blood analyzed by thromboelastography (TEG)

Other: Thromboelastography

Interventions

Thromboelastography OTHER

TEG (Thrombelastography) measurements include: Split Point (SP) is the time elapsed for the clot to initially form fibrin when the blood is first placed in the TEG machine. Reaction Time (R) is the time elapsed from its initial fibrin formation until the clot reaches 2mm. K is the time measured from R until the level of clot firmness reaches 20mm, measuring the speed of clot strengthening. These are measured in minutes. Delta measures if the formation of the clot has been suppressed; measured as the difference between R and SP. Angle reflects the speed at which clots form by forming the slope of the TEG tracing at R from the horizontal line. Maximum Amplitude (MA) in mm is the measure of maximum strength of the clot, true platelet function. G is the measure of the clot firmness; measured by a formula (G=(5000\*MA)/(100-MA) in dynes/cm2). LY30 is a measure of clot lysis at 30 minutes after MA is reached.

Also known as: TEG

Healthy Controls; Hemorrhagic Stroke; Ischemic Stroke

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All stroke patients admitted to Memorial Hermann Hospital Emergency Department receiving a confirmatory CT or MRI scan.

You may qualify if:

• At least 18 years of age or older.
• Symptoms and signs causing measurable neurologic deficit consistent with an acute stroke.
• CT or MRI consistent with stroke (ischemic or hemorrhagic) or with clinical evidence suggesting a stroke.
• For acute ischemic stroke patients, treatment with tPA and TEG blood draw must be done within 4.5 hours of symptom onset.
• For ICH patients, TEG blood draw must be done within 6 hours of symptom onset.

You may not qualify if:

• Contraindication to CT and MRI (ex. inability to lie flat)
• If ICH patient
• Hemorrhage secondary to trauma, arteriovenous malformation (AVM) or crush injury
• Planned surgical evacuation (hemicraniectomy and ventriculostomy allowed).
• Receipt of hemostatic agents (FFP, Cryo, activated factor seven) prior to TEG blood draw.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Medical School at Houston

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Ischemic Stroke; Intracranial Hemorrhages; Stroke

Interventions

Thrombelastography

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Coagulation Tests; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• James Grotta, M.D.

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair, Department of Neurology

Study Record Dates

• First Submitted: July 4, 2015
• First Posted: July 10, 2015
• Study Start: November 1, 2009
• Primary Completion: May 1, 2014
• Study Completion: December 1, 2014
• Last Updated: July 10, 2015

Record last verified: 2015-07

Locations

US (1)