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Prospective Analysis of the Use of TEG in Stroke Patients (TEG)

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ClinicalTrials.gov Identifier: NCT02494726
Recruitment Status : Completed
First Posted : July 10, 2015
Last Update Posted : July 10, 2015
Sponsor:
Information provided by (Responsible Party):
James Grotta, The University of Texas Health Science Center, Houston

Tracking Information
First Submitted Date July 4, 2015
First Posted Date July 10, 2015
Last Update Posted Date July 10, 2015
Study Start Date November 2009
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 9, 2015)
Baseline TEG in patients with spontaneous ICH vs age matched controls [ Time Frame: TEG obtained within 6 hours of last seen normal in patients with spontaneous ICH ]
Compare baseline (within 6 hours of last seen normal) TEG in patients with spontaneous ICH to TEG in age-matched controls.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: July 9, 2015)
Rapid clinical improvement after tPA (8 or greater point improvement on NIHSS score or total NIHSS 0 or 1) [ Time Frame: 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. ]
Correlate baseline (within 4.5 hours of last seen normal and prior to tPA) and 10 minute post tPA TEG values with rapid clinical improvement
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 9, 2015)
  • Hematoma enlargement in patients with spontaneous ICH [ Time Frame: CT hematoma volume at 36 +/- 12 hours compared to baseline (within 6 hours of last seen normal) ]
    Correlate baseline TEG values (within 6 hours of last seen normal) with hematoma enlargement
  • Hemorrhagic transformation after IV tPA [ Time Frame: Any bleeding on post tPA imaging 36 hours +/- 12 hrs after stroke onset ]
    Correlate baseline TEG values (within 4.5 hours of last seen normal) with hemorrhagic transformation or hemorrhage on CT 36 hours after stroke onset
  • Arterial recanalization after IV tPA [ Time Frame: Recanalization (TICI 2b or 3 flow) on imaging within 36 hours post IV tPA compared to pre-treatment ]
    Correlate baseline TEG values (within 4.5 hours of last seen normal) with recanalization (TICI 2b or 3 flow) on imaging within 36 hours post IV tPA compared to pre-treatment
  • Hyperdense Middle Cerebral Artery Sign (HDMCA) [ Time Frame: HDMCA on baseline CT in patients receiving IV tPA within 4.5 hours of last seen normal ]
    Correlate baseline TEG values (within 4.5 hours of last seen normal) with HDMCA on baseline CT imaging
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Prospective Analysis of the Use of TEG in Stroke Patients
Official Title Prospective Analysis of the Use of Thromboelastography in Stroke Patients
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.

Study Type Observational
Study Design Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All stroke patients admitted to Memorial Hermann Hospital Emergency Department receiving a confirmatory CT or MRI scan.
Condition
  • Ischemic Stroke
  • Brain Hemorrhage
Intervention Other: Thromboelastography
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.
Other Name: TEG
Study Groups/Cohorts
  • Ischemic Stroke
    Ischemic stroke patients who have had blood analyzed using thromboelastography (TEG)
    Intervention: Other: Thromboelastography
  • Healthy Controls
    Healthy controls who have had their blood analyzed using thromboelastography (TEG)
    Intervention: Other: Thromboelastography
  • Hemorrhagic Stroke
    Intracerebral hemorrhage patients who have had their blood analyzed by thromboelastography (TEG)
    Intervention: Other: Thromboelastography
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 9, 2015)
178
Original Actual Enrollment Same as current
Actual Study Completion Date December 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02494726
Other Study ID Numbers MS-09-0156
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party James Grotta, The University of Texas Health Science Center, Houston
Study Sponsor The University of Texas Health Science Center, Houston
Collaborators Not Provided
Investigators
Principal Investigator: James Grotta, M.D. The University of Texas Health Science Center, Houston
PRS Account The University of Texas Health Science Center, Houston
Verification Date July 2015