Platelet Function TestsRISTRATAVINCT03649594
Risk Stratification Post TAVI Using TEG
An observational study of Platelet Function Tests and Predictive Value of Tests, run by Torben Pottgiesser at 1 site in Germany.
Trial summary
Transcatheter aortic valve implantation (TAVI) has become the standard of care in elderly patients at increased risk for surgical aortic valve replacement . However, the optimal antithrombotic strategy post TAVI is still unclear. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Platelet Function Tests, Predictive Value of Tests, Thrombelastography
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2020to 30 Apr 2023
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients that are scheduled for TAVI using a commercially available valve after clinical decision making within the local Heart Team will be possible subjects yielding the eligibility criteria.
Who may be able to join
- Patients are eligible for enrollment if they are scheduled for TAVI using a commercially available valve after clinical decision making within the local Heart Team.
Who cannot join
- Valve-in-valve TAVI and prior valve thrombosis
- Severely impaired renal function (e.g. creatinine clearance < 30ml/min)
- poor CT imaging if the presence of HALT cannot be assessed.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Department of Cardiology and Angiology I, Heart Center Freiburg University
Freiburg im Breisgau, 79106
Christoph Olivier, MD, +49 761 270 ext. 34010, christoph.olivier@universitaets-herzzentrum.de
David Hesselbarth, MD, +49 761 270 ext. 34010, david.hesselbarth@uniklinik-freiburg.de
About this study
Official title: Risk Stratification for Subclinical Leaflet Thrombosis Post TAVI Using Thromboelastography
Transcatheter aortic valve implantation (TAVI) has become the standard of care in elderly patients at increased risk for surgical aortic valve replacement . However, the optimal antithrombotic strategy post TAVI is still unclear. Current European guidelines recommend dual antiplatelet therapy (DAPT) for 3 to 6 months.The prevalence of subclinical leaflet thrombosis after TAVI is 15% up to 40%, but its clinical long-term relevance is uncertain. Thromboelastography (TEG(R)) can be used as a point-of-care system evaluating a patient's individual hemostasis profile. For the detection of transcatheter valve thrombosis it may be superior to conventional platelet function testing because global hemostasis can be assessed in addition to platelet function. The investigators intend an observational trial recruiting patients undergoing TAVI under standard care. At defined time points the investigators will serially perform TEG(R) as well as further platelet function testing (multiple electrode aggregometry) and conventional coagulation testing. The primary objective is to find surrogate TEG-derived markers / models predicting the development of a subclinical leaflet thrombosis after TAVI under usual care. The secondary objective is to find TEG-derived markers / models identifying patients at an increased risk after TAVI (all-cause mortality, cardiovascular mortality, thromboembolic and bleeding events).
Read the detailed description
Aortic stenosis is the most common primary valve disease in high-income countries with increasing importance. Throughout the last 15 years, transcatheter aortic valve implantation (TAVI) has become an alternative to surgical aortic valve replacement, the former standard of care. Nowadays, the use of TAVI in elderly patients at increased surgical risk is favored. There is still an important lack of evidence concerning the optimal antithrombotic strategy post TAVI. Recently, it has been shown that the prevalence of subclinical leaflet thrombosis after intervention has been underestimated and may be present in around 15 % up to 40% (PORTICO IDE trial) of transcatheter valves. One study demonstrated that transient ischemic attacks are significantly increased in these patients.
European guidelines are undecided towards the length of the dual antiplatelet therapy (DAPT) after TAVI and recommend optional treatment durations between 3 to 6 months. The optimal duration of DAPT is not known, although DAPT duration is associated with an increased bleeding risk. The most recent update of AHA guidelines for valvular heart disease state that oral anticoagulation with a VKA (INR of 2.5) may be reasonable for at least 3 months after TAVI in patients at low risk of bleeding. Without favoring one over the other recommendation, the current AHA guidelines also maintain the prior statement (from 2014) that clopidogrel 75 mg daily may be reasonable for the first 6 months after TAVI in addition to life-long aspirin, which is in accordance with the European Guideline recommendation. On the other hand, the GALILEO trial has recently been stopped as patients receiving rivaroxaban after TAVI (no prior atrial fibrillation) had a higher mortality and thromboembolic events as well as higher bleeding event rates.
The TEG(R) 6S analyzer is a point-of-care system evaluating a patient's individual hemostasis profile by thrombelastography (TEG(R)), a potentially superior tool compared to conventional platelet function testing. The TEG(R) system has been able to predict thrombotic complications in different clinical contexts.
In classic coronary interventional cardiology, the strength of adenosine diphosphate (ADP)-induced and thrombin-induced platelet-fibrin clots were found to be indicators of long-term poststenting ischemic events. As the pathophysiologic mechanism of subclinical leaflet thrombosis has not been examined in detail, the investigators hypothesize that several TEG(R) assays may provide insight in finding predictive TEG(R) markers. Furthermore, as the onset of subclinical leaflet thrombosis is not clear and may possibly increase over time, the design with subsequent TEG(R) analyses at 3 timepoints (0, 3, 6 months) will help to hopefully identify predictors that may become evident at later time points.
It is intriguing to hypothesize that the better predictive marker may be found using the Global Hemostasis Assay. This is relevant as leaflet thrombosis develops despite dual antiplatelet therapy and anticoagulation has been shown to fully resolve subclinical leaflet thrombosis. The Global Hemostasis Assay may deliver prediction beyond platelet function, which may improve antithrombotic therapy post TAVI. Finding a predictive TEG marker (examining Platelet Mapping and Global Hemostasis together) holds the promise for future individualized clinical decision-making by identifying individual risk.
Taken together, we hope that individual TEG based stratification of patients at risk for subclinical leaflet thrombosis or other events may allow individual clinical decision-making.
- Conditions
- Platelet Function Tests, Predictive Value of Tests, Thrombelastography, Cardiovascular Diseases, Aortic Valve Stenosis, Thrombosis
- Medical subject headings
- Cardiovascular Diseases, Aortic Valve Stenosis, 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 |
|---|---|---|
| TAVI and no therapeutic anticoagulation | Subjects in this group do not have an indication for therapeutic anticoagulation. | |
| TAVI and therapeutic anticoagulation | Subjects in this group have an indication for therapeutic anticoagulation such as atrial fibrillation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global TEG(R)-based prediction of hypoattenuating leaflet thickening (HALT)
TEG(R)readout Global Hemostasis Assay
Measured: 6 months
Platelet TEG(R)-based prediction of hypoattenuating leaflet thickening (HALT)
TEG(R)readout Platelet Mapping Assay
Measured: 6 months
Secondary outcomes (4)
All-cause mortality within 12 months
All-cause mortality will be recorded within 12 months after TAVI.
Measured: 12 months
Cardiovascular mortality within 12 months
Cardiovascular mortality will be recorded within 12 months after TAVI.
Measured: 12 months
Thromboembolic events within 12 months
Thromboembolic events will be recorded within 12 months after TAVI.
Measured: 12 months
Bleeding events within 12 months
Bleeding events will be recorded within 12 months after TAVI.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2018
- Study start1 Oct 2020
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Platelet Function TestsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Torben Pottgiesser
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Torben Pottgiesser, University Hospital Freiburg
- Investigators
- Torben Pottgiesser, MD, Principal investigator, Cardiology and Angiology I, Heart Center Freiburg University, GermanyDaniel Duerschmied, MD, Study director, Cardiology and Angiology I, Heart Center Freiburg University, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03649594
- Sponsor's protocol ID
- RISTRATAVI-1-2019
- Acronym
- RISTRATAVI
- Status last verified
- Nov 2020
- First submitted
- 10 Aug 2018
- Last updated
- 1 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ben-Dor I, Pichard AD, Gonzalez MA, Weissman G, Li Y, Goldstein SA, Okubagzi P, Syed AI, Maluenda G, Collins SD, Delhaye C, Wakabayashi K, Gaglia MA Jr, Torguson R, Xue Z, Satler LF, Suddath WO, Kent KM, Lindsay J, Waksman R. Correlates and causes of death in patients with severe symptomatic aortic stenosis who are not eligible to participate in a clinical trial of transcatheter aortic valve implantation. Circulation. 2010 Sep 14;122(11 Suppl):S37-42. doi: 10.1161/CIRCULATIONAHA.109.926873.
PubMed 20837923Hamm CW, Arsalan M, Mack MJ. The future of transcatheter aortic valve implantation. Eur Heart J. 2016 Mar 7;37(10):803-10. doi: 10.1093/eurheartj/ehv574. Epub 2015 Nov 17.
PubMed 26578195Ruile P, Jander N, Blanke P, Schoechlin S, Reinohl J, Gick M, Rothe J, Langer M, Leipsic J, Buettner HJ, Neumann FJ, Pache G. Course of early subclinical leaflet thrombosis after transcatheter aortic valve implantation with or without oral anticoagulation. Clin Res Cardiol. 2017 Feb;106(2):85-95. doi: 10.1007/s00392-016-1052-3. Epub 2016 Nov 16.
PubMed 27853942Yanagisawa R, Hayashida K, Yamada Y, Tanaka M, Yashima F, Inohara T, Arai T, Kawakami T, Maekawa Y, Tsuruta H, Itabashi Y, Murata M, Sano M, Okamoto K, Yoshitake A, Shimizu H, Jinzaki M, Fukuda K. Incidence, Predictors, and Mid-Term Outcomes of Possible Leaflet Thrombosis After TAVR. JACC Cardiovasc Imaging. 2016 Dec 8:S1936-878X(16)30897-X. doi: 10.1016/j.jcmg.2016.11.005. Online ahead of print.
PubMed 28017712Makkar RR, Fontana G, Jilaihawi H, Chakravarty T, Kofoed KF, De Backer O, Asch FM, Ruiz CE, Olsen NT, Trento A, Friedman J, Berman D, Cheng W, Kashif M, Jelnin V, Kliger CA, Guo H, Pichard AD, Weissman NJ, Kapadia S, Manasse E, Bhatt DL, Leon MB, Sondergaard L. Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves. N Engl J Med. 2015 Nov 19;373(21):2015-24. doi: 10.1056/NEJMoa1509233. Epub 2015 Oct 5.
PubMed 26436963Chakravarty T, Sondergaard L, Friedman J, De Backer O, Berman D, Kofoed KF, Jilaihawi H, Shiota T, Abramowitz Y, Jorgensen TH, Rami T, Israr S, Fontana G, de Knegt M, Fuchs A, Lyden P, Trento A, Bhatt DL, Leon MB, Makkar RR; RESOLVE; SAVORY Investigators. Subclinical leaflet thrombosis in surgical and transcatheter bioprosthetic aortic valves: an observational study. Lancet. 2017 Jun 17;389(10087):2383-2392. doi: 10.1016/S0140-6736(17)30757-2. Epub 2017 Mar 19.
PubMed 28330690Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ, Iung B, Lancellotti P, Lansac E, Rodriguez Munoz D, Rosenhek R, Sjogren J, Tornos Mas P, Vahanian A, Walther T, Wendler O, Windecker S, Zamorano JL; ESC Scientific Document Group. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2017 Sep 21;38(36):2739-2791. doi: 10.1093/eurheartj/ehx391. No abstract available.
PubMed 28886619Valgimigli M, Campo G, Monti M, Vranckx P, Percoco G, Tumscitz C, Castriota F, Colombo F, Tebaldi M, Fuca G, Kubbajeh M, Cangiano E, Minarelli M, Scalone A, Cavazza C, Frangione A, Borghesi M, Marchesini J, Parrinello G, Ferrari R; Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia Study (PRODIGY) Investigators. Short- versus long-term duration of dual-antiplatelet therapy after coronary stenting: a randomized multicenter trial. Circulation. 2012 Apr 24;125(16):2015-26. doi: 10.1161/CIRCULATIONAHA.111.071589. Epub 2012 Mar 21.
PubMed 22438530Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Fleisher LA, Jneid H, Mack MJ, McLeod CJ, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A. 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2017 Jul 11;70(2):252-289. doi: 10.1016/j.jacc.2017.03.011. Epub 2017 Mar 15. No abstract available.
PubMed 28315732Parker RJ, Eley KA, Von Kier S, Pearson O, Watt-Smith SR. Functional fibrinogen to platelet ratio using thromboelastography as a predictive parameter for thrombotic complications following free tissue transfer surgery: a preliminary study. Microsurgery. 2012 Oct;32(7):512-9. doi: 10.1002/micr.21978. Epub 2012 Mar 31.
PubMed 22473821Krzanicki D, Sugavanam A, Mallett S. Intraoperative hypercoagulability during liver transplantation as demonstrated by thromboelastography. Liver Transpl. 2013 Aug;19(8):852-61. doi: 10.1002/lt.23668. Epub 2013 Jul 8.
PubMed 23696318Gurbel PA, Bliden KP, Navickas IA, Mahla E, Dichiara J, Suarez TA, Antonino MJ, Tantry US, Cohen E. Adenosine diphosphate-induced platelet-fibrin clot strength: a new thrombelastographic indicator of long-term poststenting ischemic events. Am Heart J. 2010 Aug;160(2):346-54. doi: 10.1016/j.ahj.2010.05.034.
PubMed 20691842Pache G, Schoechlin S, Blanke P, Dorfs S, Jander N, Arepalli CD, Gick M, Buettner HJ, Leipsic J, Langer M, Neumann FJ, Ruile P. Early hypo-attenuated leaflet thickening in balloon-expandable transcatheter aortic heart valves. Eur Heart J. 2016 Jul 21;37(28):2263-71. doi: 10.1093/eurheartj/ehv526. Epub 2015 Oct 7.
PubMed 26446193Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Stratification for Subclinical Leaflet Thrombosis Post TAVI Using Thromboelastography
- ClinicalTrials.gov ID
- NCT03649594
- Acronym / sponsor ID
- RISTRATAVI / RISTRATAVI-1-2019
- Conditions
- Platelet Function Tests, Predictive Value of Tests, Thrombelastography, Cardiovascular Diseases, Aortic Valve Stenosis, Thrombosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Torben PottgiesserUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 28 Aug 2018 (actual)
- 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.
Transcatheter aortic valve implantation (TAVI) has become the standard of care in elderly patients at increased risk for surgical aortic valve replacement . However, the optimal antithrombotic strategy post TAVI is still unclear. Current European guidelines recommend dual antiplatelet therapy (DAPT) for 3 to 6 months.The prevalence of subclinical leaflet thrombosis after TAVI is 15% up to 40%, but its clinical long-term relevance is uncertain. Thromboelastography (TEG(R)) can be used as a point-of-care system evaluating a patient's individual hemostasis profile. For the detection of transcatheter valve thrombosis it may be superior to conventional platelet function testing because global hemostasis can be assessed in addition to platelet function. The investigators intend an observational trial recruiting patients undergoing TAVI under standard care. At defined time points the investigators will serially perform TEG(R) as well as further platelet function testing (multiple electrode aggregometry) and conventional coagulation testing. The primary objective is to find surrogate TEG-derived markers / models predicting the development of a subclinical leaflet thrombosis after TAVI under usual care. The secondary objective is to find TEG-derived markers / models identifying patients at an increased risk after TAVI (all-cause mortality, cardiovascular mortality, thromboembolic and bleeding events).
Detailed description
Aortic stenosis is the most common primary valve disease in high-income countries with increasing importance. Throughout the last 15 years, transcatheter aortic valve implantation (TAVI) has become an alternative to surgical aortic valve replacement, the former standard of care. Nowadays, the use of TAVI in elderly patients at increased surgical risk is favored. There is still an important lack of evidence concerning the optimal antithrombotic strategy post TAVI. Recently, it has been shown that the prevalence of subclinical leaflet thrombosis after intervention has been underestimated and may be present in around 15 % up to 40% (PORTICO IDE trial) of transcatheter valves. One study demonstrated that transient ischemic attacks are significantly increased in these patients.
European guidelines are undecided towards the length of the dual antiplatelet therapy (DAPT) after TAVI and recommend optional treatment durations between 3 to 6 months. The optimal duration of DAPT is not known, although DAPT duration is associated with an increased bleeding risk. The most recent update of AHA guidelines for valvular heart disease state that oral anticoagulation with a VKA (INR of 2.5) may be reasonable for at least 3 months after TAVI in patients at low risk of bleeding. Without favoring one over the other recommendation, the current AHA guidelines also maintain the prior statement (from 2014) that clopidogrel 75 mg daily may be reasonable for the first 6 months after TAVI in addition to life-long aspirin, which is in accordance with the European Guideline recommendation. On the other hand, the GALILEO trial has recently been stopped as patients receiving rivaroxaban after TAVI (no prior atrial fibrillation) had a higher mortality and thromboembolic events as well as higher bleeding event rates.
The TEG(R) 6S analyzer is a point-of-care system evaluating a patient's individual hemostasis profile by thrombelastography (TEG(R)), a potentially superior tool compared to conventional platelet function testing. The TEG(R) system has been able to predict thrombotic complications in different clinical contexts.
In classic coronary interventional cardiology, the strength of adenosine diphosphate (ADP)-induced and thrombin-induced platelet-fibrin clots were found to be indicators of long-term poststenting ischemic events. As the pathophysiologic mechanism of subclinical leaflet thrombosis has not been examined in detail, the investigators hypothesize that several TEG(R) assays may provide insight in finding predictive TEG(R) markers. Furthermore, as the onset of subclinical leaflet thrombosis is not clear and may possibly increase over time, the design with subsequent TEG(R) analyses at 3 timepoints (0, 3, 6 months) will help to hopefully identify predictors that may become evident at later time points.
It is intriguing to hypothesize that the better predictive marker may be found using the Global Hemostasis Assay. This is relevant as leaflet thrombosis develops despite dual antiplatelet therapy and anticoagulation has been shown to fully resolve subclinical leaflet thrombosis. The Global Hemostasis Assay may deliver prediction beyond platelet function, which may improve antithrombotic therapy post TAVI. Finding a predictive TEG marker (examining Platelet Mapping and Global Hemostasis together) holds the promise for future individualized clinical decision-making by identifying individual risk.
Taken together, we hope that individual TEG based stratification of patients at risk for subclinical leaflet thrombosis or other events may allow individual clinical decision-making.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAVI and no therapeutic anticoagulation | – | –Subjects in this group do not have an indication for therapeutic anticoagulation. |
| TAVI and therapeutic anticoagulation | – | –Subjects in this group have an indication for therapeutic anticoagulation such as atrial fibrillation. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients that are scheduled for TAVI using a commercially available valve after clinical decision making within the local Heart Team will be possible subjects yielding the eligibility criteria.
Key inclusion criteria (1 listed)
- Patients are eligible for enrollment if they are scheduled for TAVI using a commercially available valve after clinical decision making within the local Heart Team.
Key exclusion criteria (3 listed)
- Valve-in-valve TAVI and prior valve thrombosis
- Severely impaired renal function (e.g. creatinine clearance < 30ml/min)
- poor CT imaging if the presence of HALT cannot be assessed.
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
Global TEG(R)-based prediction of hypoattenuating leaflet thickening (HALT)
Time frame: 6 months
TEG(R)readout Global Hemostasis Assay
Platelet TEG(R)-based prediction of hypoattenuating leaflet thickening (HALT)
Time frame: 6 months
TEG(R)readout Platelet Mapping Assay
4 secondary outcomes
All-cause mortality within 12 months
Time frame: 12 months
Cardiovascular mortality within 12 months
Time frame: 12 months
Thromboembolic events within 12 months
Time frame: 12 months
Bleeding events within 12 months
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2020.
- Background: PubMed 20837923Ben-Dor I, Pichard AD, Gonzalez MA, Weissman G, Li Y, Goldstein SA, Okubagzi P, Syed AI, Maluenda G, Collins SD, Delhaye C, Wakabayashi K, Gaglia MA Jr, Torguson R, Xue Z, Satler LF, Suddath WO, Kent KM, Lindsay J, Waksman R. Correlates and causes of death in patients with severe symptomatic aortic stenosis who are not eligible to participate in a clinical trial of transcatheter aortic valve implantation. Circulation. 2010 Sep 14;122(11 Suppl):S37-42. doi: 10.1161/CIRCULATIONAHA.109.926873.
- Background: PubMed 26578195Hamm CW, Arsalan M, Mack MJ. The future of transcatheter aortic valve implantation. Eur Heart J. 2016 Mar 7;37(10):803-10. doi: 10.1093/eurheartj/ehv574. Epub 2015 Nov 17.
- Background: PubMed 27853942Ruile P, Jander N, Blanke P, Schoechlin S, Reinohl J, Gick M, Rothe J, Langer M, Leipsic J, Buettner HJ, Neumann FJ, Pache G. Course of early subclinical leaflet thrombosis after transcatheter aortic valve implantation with or without oral anticoagulation. Clin Res Cardiol. 2017 Feb;106(2):85-95. doi: 10.1007/s00392-016-1052-3. Epub 2016 Nov 16.
- Background: PubMed 28017712Yanagisawa R, Hayashida K, Yamada Y, Tanaka M, Yashima F, Inohara T, Arai T, Kawakami T, Maekawa Y, Tsuruta H, Itabashi Y, Murata M, Sano M, Okamoto K, Yoshitake A, Shimizu H, Jinzaki M, Fukuda K. Incidence, Predictors, and Mid-Term Outcomes of Possible Leaflet Thrombosis After TAVR. JACC Cardiovasc Imaging. 2016 Dec 8:S1936-878X(16)30897-X. doi: 10.1016/j.jcmg.2016.11.005. Online ahead of print.
- Background: PubMed 26436963Makkar RR, Fontana G, Jilaihawi H, Chakravarty T, Kofoed KF, De Backer O, Asch FM, Ruiz CE, Olsen NT, Trento A, Friedman J, Berman D, Cheng W, Kashif M, Jelnin V, Kliger CA, Guo H, Pichard AD, Weissman NJ, Kapadia S, Manasse E, Bhatt DL, Leon MB, Sondergaard L. Possible Subclinical Leaflet Thrombosis in Bioprosthetic Aortic Valves. N Engl J Med. 2015 Nov 19;373(21):2015-24. doi: 10.1056/NEJMoa1509233. Epub 2015 Oct 5.
- Background: PubMed 28330690Chakravarty T, Sondergaard L, Friedman J, De Backer O, Berman D, Kofoed KF, Jilaihawi H, Shiota T, Abramowitz Y, Jorgensen TH, Rami T, Israr S, Fontana G, de Knegt M, Fuchs A, Lyden P, Trento A, Bhatt DL, Leon MB, Makkar RR; RESOLVE; SAVORY Investigators. Subclinical leaflet thrombosis in surgical and transcatheter bioprosthetic aortic valves: an observational study. Lancet. 2017 Jun 17;389(10087):2383-2392. doi: 10.1016/S0140-6736(17)30757-2. Epub 2017 Mar 19.
- Background: PubMed 28886619Baumgartner H, Falk V, Bax JJ, De Bonis M, Hamm C, Holm PJ, Iung B, Lancellotti P, Lansac E, Rodriguez Munoz D, Rosenhek R, Sjogren J, Tornos Mas P, Vahanian A, Walther T, Wendler O, Windecker S, Zamorano JL; ESC Scientific Document Group. 2017 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2017 Sep 21;38(36):2739-2791. doi: 10.1093/eurheartj/ehx391. No abstract available.
- Background: PubMed 22438530Valgimigli M, Campo G, Monti M, Vranckx P, Percoco G, Tumscitz C, Castriota F, Colombo F, Tebaldi M, Fuca G, Kubbajeh M, Cangiano E, Minarelli M, Scalone A, Cavazza C, Frangione A, Borghesi M, Marchesini J, Parrinello G, Ferrari R; Prolonging Dual Antiplatelet Treatment After Grading Stent-Induced Intimal Hyperplasia Study (PRODIGY) Investigators. Short- versus long-term duration of dual-antiplatelet therapy after coronary stenting: a randomized multicenter trial. Circulation. 2012 Apr 24;125(16):2015-26. doi: 10.1161/CIRCULATIONAHA.111.071589. Epub 2012 Mar 21.
- Background: PubMed 28315732Nishimura RA, Otto CM, Bonow RO, Carabello BA, Erwin JP 3rd, Fleisher LA, Jneid H, Mack MJ, McLeod CJ, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A. 2017 AHA/ACC Focused Update of the 2014 AHA/ACC Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. J Am Coll Cardiol. 2017 Jul 11;70(2):252-289. doi: 10.1016/j.jacc.2017.03.011. Epub 2017 Mar 15. No abstract available.
- Background: PubMed 22473821Parker RJ, Eley KA, Von Kier S, Pearson O, Watt-Smith SR. Functional fibrinogen to platelet ratio using thromboelastography as a predictive parameter for thrombotic complications following free tissue transfer surgery: a preliminary study. Microsurgery. 2012 Oct;32(7):512-9. doi: 10.1002/micr.21978. Epub 2012 Mar 31.
- Background: PubMed 23696318Krzanicki D, Sugavanam A, Mallett S. Intraoperative hypercoagulability during liver transplantation as demonstrated by thromboelastography. Liver Transpl. 2013 Aug;19(8):852-61. doi: 10.1002/lt.23668. Epub 2013 Jul 8.
- Background: PubMed 20691842Gurbel PA, Bliden KP, Navickas IA, Mahla E, Dichiara J, Suarez TA, Antonino MJ, Tantry US, Cohen E. Adenosine diphosphate-induced platelet-fibrin clot strength: a new thrombelastographic indicator of long-term poststenting ischemic events. Am Heart J. 2010 Aug;160(2):346-54. doi: 10.1016/j.ahj.2010.05.034.
- Individual participant dataSharing planned: No
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RecruitingObservational study
Prediction of Platelet Function Using Viscoelastic Test (ROTEM® Sigma) in Obstetric Anesthesia.
Thrombocytopenia, Postpartum Haemorrhage (PPH)
RecruitingPhase 3
Study of the Long-term Effects of P2Y12 Inhibitor Monotherapy and Coagulation Markers After Percutaneous Coronary Angioplasty.
Coronary Artery Disease, Percutaneous Coronary Intervention
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.
Torben Pottgiesser, MD principal investigator
Cardiology and Angiology I, Heart Center Freiburg University, Germany
Daniel Duerschmied, MD study director
Cardiology and Angiology I, Heart Center Freiburg University, Germany
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 Platelet Function Tests and Predictive Value of Tests, run by Torben Pottgiesser at 1 site in Germany.
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 1 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: status not confirmed, as of the sponsor's last update on 1 Dec 2020. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Torben Pottgiesser, MD (+49761270 ext. 34010, torben.pottgiesser@uniklinik-freiburg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global TEG(R)-based prediction of hypoattenuating leaflet thickening (HALT) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03649594, which also lists 14 linked publications.
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 1 Dec 2020.