CoagulationR-TEG MANCT01428102
RapidTEG MA Validation
An observational study of Coagulation and Platelet Function, run by Haemonetics Corporation at 2 sites in United States.
Trial summary
During normal physiological conditions hemostasis (the ability of blood to clot) is kept in homeostatic balance by feedback mechanisms. These mechanisms involve an extremely complex series of steps on both sides of the coagulation cascade including cellular components (i.e. clot formation and breakdown). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coagulation, Platelet Function
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2011to Oct 2012
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patient is either a Trauma patient OR is diagnosed with known cardiovascular disease.
Who may be able to join
- Patient age > 18 years old
- Patient is either a Trauma patient OR is diagnosed with known cardiovascular disease.
- Samples must be tested within the recommended timeline (4-6 minutes for non-citrated and between 15 minutes and 2 hours for citrated)
Who cannot join
- Patients who have been placed on anticoagulation prophylaxis for other conditions (not CPB/PCI related).
- Patients who have established hemostasis system abnormalities (congenital or other).
- Samples identified as affected by testing errors by lab staff.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Sinai Center for Thrombosis Research
Baltimore, Maryland, 21215
Univserity of Tennessee Health Sciences Center
Knoxville, Tennessee, 37996-1529
About this study
Official title: Validation of the RapidTEG™ MA Compared to Kaolin in Trauma and Cardiac Patients.
During normal physiological conditions hemostasis (the ability of blood to clot) is kept in homeostatic balance by feedback mechanisms. These mechanisms involve an extremely complex series of steps on both sides of the coagulation cascade including cellular components (i.e. clot formation and breakdown). However, should this homeostatic balance be upset, normal hemostasis is affected resulting in pathological clotting (vessel blockage) or bleeding (hemorrhage). In instances that include acquired or congenital abnormalities of the hemostatic system it is clinically important to diagnose, monitor and manage the patient to optimize therapeutic intervention. Moreover, it is important to regulate the hemostasis system in the post-surgical outpatient who receives oral anticoagulant therapy to maintain the homeostatic balance.
The TEG® analyzer, using a small whole blood sample, documents the interaction of platelets with the protein coagulation cascade from the time of placing the blood in the analyzer until initial fibrin formation, clot rate strengthening and fibrin-platelet bonding via GPIIb/IIIa, through eventual clot lysis. It displays both qualitatively and quantitatively the two distinct parts of hemostasis - the part that produces the clot and the part that causes the breakdown of the clot. It shows the balance or degree of imbalance in the patient's hemostasis system, highlights any areas of deficiency or excess, and offers a precise view of the patient's hemostasis condition. If the system is not in balance, one can see where the imbalance lies. If a patient is bleeding, it is crucial to determine the cause of bleeding as soon as possible in order to start the proper treatment.
Read more
By utilizing a kaolin/tissue factor activator (RapidTEG™), the TEG® system can measure the interaction and simultaneous contribution of the intrinsic and extrinsic coagulation pathways which initiate and result in clot formation. This RapidTEG™ reagent can deliver results faster than activating with Kaolin alone. This protocol will specifically assess one algorithm called MA. MA is a direct function of the maximum dynamic properties of fibrin and platelet bonding via GPIIb/IIIa that represents the ultimate strength of the fibrin clot. This represents platelet function.
The objective of the study is to demonstrate the substantial equivalence of MA RapidTEG vs. MA Kaolin.
- Conditions
- Coagulation, Platelet Function
- Keywords
- Thromboelastography, TEG, Coagulation, RapidTEG, Kaolin
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| RapidTEG | Samples tested with TEG which are both citrated and non-citrated and are activated using the reagent RapidTEG. | |
| Kaolin | Samples tested with TEG which are both citrated and non-citrated and are activated using the reagent Kaolin. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correelation of Kaolin to RapidTEG
TEG paramaters were to be correlated in samples run concurrently using Kaolin and RapidTEG assays.
Measured: Concurrent sample tested <2hrs from blood draw
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2011 (estimated)
- Study startJul 2011
- Primary completionOct 2012
- Study completionOct 2012
Why it stopped: Terminiated for trial redesign
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoagulationStudies of the same condition, open and under way.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haemonetics Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01428102
- Sponsor's protocol ID
- TP-CLN-100267A
- Acronym
- R-TEG MA
- Status last verified
- Sep 2013
- First submitted
- 1 Sep 2011
- Last updated
- 16 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the RapidTEG™ MA Compared to Kaolin in Trauma and Cardiac Patients.
- ClinicalTrials.gov ID
- NCT01428102
- Acronym / sponsor ID
- R-TEG MA / TP-CLN-100267A
- Conditions
- Coagulation, Platelet Function
- Keywords
- Thromboelastography, TEG, Coagulation, RapidTEG, Kaolin
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Terminiated for trial redesign
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Haemonetics CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 2 Sep 2011 (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.
During normal physiological conditions hemostasis (the ability of blood to clot) is kept in homeostatic balance by feedback mechanisms. These mechanisms involve an extremely complex series of steps on both sides of the coagulation cascade including cellular components (i.e. clot formation and breakdown). However, should this homeostatic balance be upset, normal hemostasis is affected resulting in pathological clotting (vessel blockage) or bleeding (hemorrhage). In instances that include acquired or congenital abnormalities of the hemostatic system it is clinically important to diagnose, monitor and manage the patient to optimize therapeutic intervention. Moreover, it is important to regulate the hemostasis system in the post-surgical outpatient who receives oral anticoagulant therapy to maintain the homeostatic balance.
The TEG® analyzer, using a small whole blood sample, documents the interaction of platelets with the protein coagulation cascade from the time of placing the blood in the analyzer until initial fibrin formation, clot rate strengthening and fibrin-platelet bonding via GPIIb/IIIa, through eventual clot lysis. It displays both qualitatively and quantitatively the two distinct parts of hemostasis - the part that produces the clot and the part that causes the breakdown of the clot. It shows the balance or degree of imbalance in the patient's hemostasis system, highlights any areas of deficiency or excess, and offers a precise view of the patient's hemostasis condition. If the system is not in balance, one can see where the imbalance lies. If a patient is bleeding, it is crucial to determine the cause of bleeding as soon as possible in order to start the proper treatment.
By utilizing a kaolin/tissue factor activator (RapidTEG™), the TEG® system can measure the interaction and simultaneous contribution of the intrinsic and extrinsic coagulation pathways which initiate and result in clot formation. This RapidTEG™ reagent can deliver results faster than activating with Kaolin alone. This protocol will specifically assess one algorithm called MA. MA is a direct function of the maximum dynamic properties of fibrin and platelet bonding via GPIIb/IIIa that represents the ultimate strength of the fibrin clot. This represents platelet function.
The objective of the study is to demonstrate the substantial equivalence of MA RapidTEG vs. MA Kaolin.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RapidTEG | – | –Samples tested with TEG which are both citrated and non-citrated and are activated using the reagent RapidTEG. |
| Kaolin | – | –Samples tested with TEG which are both citrated and non-citrated and are activated using the reagent Kaolin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient is either a Trauma patient OR is diagnosed with known cardiovascular disease.
Key inclusion criteria (3 listed)
- Patient age > 18 years old
- Patient is either a Trauma patient OR is diagnosed with known cardiovascular disease.
- Samples must be tested within the recommended timeline (4-6 minutes for non-citrated and between 15 minutes and 2 hours for citrated)
Key exclusion criteria (3 listed)
- Patients who have been placed on anticoagulation prophylaxis for other conditions (not CPB/PCI related).
- Patients who have established hemostasis system abnormalities (congenital or other).
- Samples identified as affected by testing errors by lab staff.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correelation of Kaolin to RapidTEG
Time frame: Concurrent sample tested <2hrs from blood draw
TEG paramaters were to be correlated in samples run concurrently using Kaolin and RapidTEG assays.
Results and safety
The study was stopped early (reason given: Terminiated for trial redesign). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coagulation and Platelet Function, run by Haemonetics Corporation at 2 sites 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 16 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: Terminiated for trial redesign). Results are not available in the source record.
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?
Correelation of Kaolin to RapidTEG (time frame: Concurrent sample tested <2hrs from blood draw). 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 16 Sep 2013.