Clinical trial NCT02494726: Prospective Analysis of the Use of TEG in Stroke Patients
Official title: Prospective Analysis of the Use of Thromboelastography in Stroke Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Brain Hemorrhage
Keywords: Ischemic stroke
ICH stroke
TEG
Thromboelastography
Stroke
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2015-07-10
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All stroke patients admitted to Memorial Hermann Hospital Emergency Department receiving a confirmatory CT or MRI scan.

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.

Detailed description: Thromboelastography (TEG), a computerized analysis that has been used since the 1940s, is the only stand alone test that can provide integrated information on the balance between the two separate but simultaneously occuring components of coagulation, thrombosis and lysis. It measures the coagulation process from initial clotting cascade to clot strength.

TEG may be used to assess the coagulation status of patients with acute stroke, whether ischemic or hemorrhagic. TEG might also be a useful way to predict and assess the degree of fibrinolysis that is achieved by tissue plasminogen activator (tPA). Currently tPA is given as a standard dose determined by the patient's body weight, thus given the variability in patient outcome after tPA, this dose could sometimes be too small or too large, leading to thrombolysis or bleeding, respectively. One of the purposes of this observational study is to evaluate how effective TEG is on predicting and assessing the degree of thrombolysis following tPA therapy, by producing a range of TEG values correlated with optimal thrombolysis.

The results of the recent FAST trial demonstrated the need to identify patients with spontaneous intracerebral hemorrhage (ICH) who are at increased risk for hematoma enlargement. Such identified patients, could benefit from a therapeutic advantage of activated factor VII or other hemostatic agents may be more clearly studied. Therefore, another purpose of this study is to evaluate how effective TEG is on predicting further bleeding for patients with spontaneous ICH.

The study will consist of 208 ischemic patients and 80 hemorrhagic patients, whom which are approached from all stroke patients admitted to Memorial Hermann Hospital Emergency Department receiving a confirmatory CT or MRI scan. Patients who agree to participate will have blood drawn the day of hospital arrival, will then be followed for 36 +/- 12 hours after the stroke, and 90 +/- 30 days after the stroke, all during which two more blood samples will be obtained.

Normal controls will be age and sex matched to the investigators' research population. A one-time blood draw will be obtained and information collected will be age, sex and TEG values.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Baseline TEG in patients with spontaneous ICH vs age matched controls
timeFrame: TEG obtained within 6 hours of last seen normal in patients with spontaneous ICH
Secondary outcomes:
measure: Rapid clinical improvement after tPA (8 or greater point improvement on NIHSS score or total NIHSS 0 or 1)
timeFrame: 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:
measure: Hematoma enlargement in patients with spontaneous ICH
timeFrame: CT hematoma volume at 36 +/- 12 hours compared to baseline (within 6 hours of last seen normal)
measure: Hemorrhagic transformation after IV tPA
timeFrame: Any bleeding on post tPA imaging 36 hours +/- 12 hrs after stroke onset
measure: Arterial recanalization after IV tPA
timeFrame: Recanalization (TICI 2b or 3 flow) on imaging within 36 hours post IV tPA compared to pre-treatment
measure: Hyperdense Middle Cerebral Artery Sign (HDMCA)
timeFrame: HDMCA on baseline CT in patients receiving IV tPA within 4.5 hours of last seen normal
Locations:
city: Houston
country: United States
facility: The University of Texas Medical School at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: James Grotta, M.D.
role: PRINCIPAL_INVESTIGATOR
References: