Ischemic StrokeTEGNCT02494726
Prospective Analysis of the Use of TEG in Stroke Patients
An observational study of Ischemic Stroke and Brain Hemorrhage, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ischemic Stroke, Brain Hemorrhage
- What is being tested?
- Thromboelastography
- How many people
- 178 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to Dec 2014
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All stroke patients admitted to Memorial Hermann Hospital Emergency Department receiving a confirmatory CT or MRI scan.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Medical School at Houston
Houston, Texas, 77030
About this study
Official title: Prospective Analysis of the Use of Thromboelastography in Stroke Patients
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.
Read the 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.
- Conditions
- Ischemic Stroke, Brain Hemorrhage
- Being tested
- Thromboelastography
- Keywords
- Ischemic stroke, ICH stroke, TEG, Thromboelastography, Stroke
- Medical subject headings
- Ischemic Stroke, Intracranial Hemorrhages, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThromboelastographyOther
Also called TEG
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.
| Study group | Role | What they receive |
|---|---|---|
| Ischemic Stroke | Ischemic stroke patients who have had blood analyzed using thromboelastography (TEG) Receives: Other: Thromboelastography | |
| Healthy Controls | Healthy controls who have had their blood analyzed using thromboelastography (TEG) Receives: Other: Thromboelastography | |
| Hemorrhagic Stroke | Intracerebral hemorrhage patients who have had their blood analyzed by thromboelastography (TEG) Receives: Other: Thromboelastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2015 (estimated)
- Study startNov 2009
- Primary completionMay 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Grotta, The University of Texas Health Science Center, Houston
- Investigators
- James Grotta, M.D., Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02494726
- Sponsor's protocol ID
- MS-09-0156
- Acronym
- TEG
- Status last verified
- Jul 2015
- First submitted
- 4 Jul 2015
- Last updated
- 10 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of the Use of Thromboelastography in Stroke Patients
- ClinicalTrials.gov ID
- NCT02494726
- Acronym / sponsor ID
- TEG / MS-09-0156
- Conditions
- Ischemic Stroke, Brain Hemorrhage
- Keywords
- Ischemic stroke, ICH stroke, TEG, Thromboelastography, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- May 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 10 Jul 2015 (estimated)
- 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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ischemic Stroke | – | Other: ThromboelastographyIschemic stroke patients who have had blood analyzed using thromboelastography (TEG) |
| Healthy Controls | – | Other: ThromboelastographyHealthy controls who have had their blood analyzed using thromboelastography (TEG) |
| Hemorrhagic Stroke | – | Other: ThromboelastographyIntracerebral hemorrhage patients who have had their blood analyzed by thromboelastography (TEG) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All stroke patients admitted to Memorial Hermann Hospital Emergency Department receiving a confirmatory CT or MRI scan.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| ThromboelastographyAlso: TEGTEG (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 | Healthy Controls, Hemorrhagic Stroke, Ischemic Stroke |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2015.
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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.
James Grotta, M.D. principal investigator
The University of Texas Health Science Center, Houston
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 Ischemic Stroke and Brain Hemorrhage, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 5 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: finished, as of the sponsor's last update on 10 Jul 2015. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 10 Jul 2015.