Pulmonary EmbolismNCT05512702
Reduced Dose Thrombolytic in Intermediate/High Risk Pulmonary Thromboembolism
An observational study of Pulmonary Embolism, run by Ege University at 1 site in Turkey (Türkiye).
Trial summary
Pulmonary Embolism(PE) requires multidisciplinary approach as a highly morbid and mortal disease. This multidisciplinary approach creates clinical benefits in diagnostic and therapeutic process. And these benefits are pointed out in certain studies and guidelines. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Tissue Plasminogen Activator, Alteplase and Low-molecular weight heparin
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Jun 2022to 3 Jun 2024
- 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: In this study, intermediate-high risk PE patients will divide whether receice thrombolytic treatment or not. And two group are going to compare in the context of mortality rate. We anticipate that 50 patients should be enough for statistically powerful study. We predict this number according to previous studies and power analyses.
Who may be able to join
- Patients which are in intermediate-high risk class ased on mortality in the ESC/ERS Pulmonary Embolism Risk Classification
Who cannot join
- Unwillingness of patient to participate in the study
- The case is in the intermediate-high risk class, but there is an unstable disease that will affect mortality due to malignancy or general medical condition.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ege University
Izmir, Bornova/İzmir, 35100
Pervin KORKMAZ, MD, +902323902900, pervinkorkmaz@yahoo.com
Ömer Selim UNAT, MD, +902323902900, unatomerselim@gmail.com
About this study
Official title: Treatment Approach in Patients Diagnosed With Pulmonary Thromboembolism With Intermediate-High Risk Interms of Early Mortality After the Establisment of Ege Pulmonary Embolism Team
Pulmonary Embolism(PE) requires multidisciplinary approach as a highly morbid and mortal disease. This multidisciplinary approach creates clinical benefits in diagnostic and therapeutic process. And these benefits are pointed out in certain studies and guidelines. For these reasons, a Pulmonary Embolism Response Team (PERT) was established on 5 th November 2018 which is called as Ege Pulmonary Embolism Team (EGEPET) in our university.
In recent years, it is stated that the carefully use of thrombolytic in patients with intermediate-high risk PE based on early mortality classification. Some studies have reported that the use of thrombolytic may cause clinical benefits. But which used drug and which dose are not defined clearly yet.
Read more
After establishment of EGEPET, the investigators observed that patients with intermediate-high risk PE more receive reduced dose thrombolytic than the pre-EGEPET period. And the investigators aimed to compare treatment changes after and before the establishment of EGEPET. Also, the investigator will compare initial reduced dose thrombolytic therapy after EGEPET with initial anticoagulation therapy before EGEPET (historical group) in terms of mortality and complication.
As the reduced dose thrombolytic, Alteplase 50 mg is used in our hospital. Low-molecular weight heparin (LMWH), standard heparin and rarely Fondaparinux are used for anticoagulation therapy. Low-molecular weight heparin is generally applied for treatment, in case there is no contraindication.
Our primary end-point is to assess 30-day mortality and secondary-end points are to detect in one year-mortality and complications. The investigators will compare the mortality and complication rates in these groups.
N0 hypothesis; In the intermediate-high risk group diagnosed with PE, there is an increased mortality rate in the patients treated with half-dose thrombolytic (Alteplase 50 mg) than our historical group or the literature.
N1 hypothesis; In the intermediate-high risk group diagnosed with PE, there is no an increased mortality rate in the patients treated with half-dose thrombolytic (Alteplase 50 mg) than our historical group or the literature.
Read the detailed description
Pulmonary thromboembolism ranks 3rd among cardiovascular diseases in terms of mortality. Pulmonary Embolism (PE) is a challenging disease that requires rapid approach both in the diagnosis and treatment process. Due to the challenging nature of the disease, Pulmonary Embolism Response Teams (PERT) have emerged for quick intervention in patients with PE. In the management of PE, multidisciplinary approach that includes the branches of pulmonary diseases, cardiology, emergency medicine, cardiovascular surgery, anesthesiology and radiology provides clinical advantages. Therefore, a PERT was established and called Ege Pulmonary Embolism Team (EGEPET). EGEPET established on 5th of November 2018. This team contains specialists from Pulmonary Diseases, Cardiology, Emergency Medicine, Cardiovascular Surgery, Anesthesiology and Radiology Departments. EGEPET works during 7/24 as a response team. It has been stated in recent publications and pulmonary thromboembolism guidelines that the establishment of multidisciplinary study group which is similar to our group will be more effective in the diagnosis, treatment and follow-up processes of PE patients.
Specially, there are some different opinions for the treatment of Intermediate-High risk based on according to early mortality with PE patients. While some guidelines suggest initial anticoagulation treatment without thrombolytic treatment, some researchers state that thrombolytic treatment can be used in Intermediate-High risk patients. These researchers indicate that the careful use of thrombolytic can be improved in clinical situation of PE patients. The careful usage is meant to use reduced dose thrombolytic and to follow up the patients closely for bleeding complication.
In cases diagnosed with intermediate-high risk PE in related to early mortality, it has been seen that half-dose thrombolytics are given mostly in our daily life practice after EGEPET.
So, the investigators planned to evaluate the mortality and morbidity rates in the patients who were diagnosed with pulmonary thromboembolism with intermediate-high risk in terms of early mortality and who received half-dose thrombolytics according to the result of the EGEPET consultation.
50 mg Alteplase is used as thrombolytic treatment and, low-molecular weight heparin (LMWH), standard heparin and rarely Fondaparinux are used for initial anticoagulation treatment. Low-molecular weight heparin is generally applied for treatment, in case there is no contraindication.
This study is an observational drug study. Researchers of this study did not and will not intervene the treatment of patients. Treatment decision of the patients is decided by EGEPET physicians.
The investigators will compare the patients diagnosed with intermediate-high risk PE who received reduced dose thrombolytic which the decision is made by EGEPET with the other patients who did not get thrombolytic treatment in terms of mortality and morbidity.
The other patient group with intermediate-high risk PE will be created from our historical data to prevent to selection bias. Because, EGEPET offers generally reduced dose thrombolytic in intermediate-high risk PE patients. Otherwise, patients having high bleeding scores (e.g. RIETE bleeding score), multiple and severe comorbidities or patients who are quite old generally receive only anticoagulation treatment.
The patients assessed our study were classed into three groups. All of the patients have PE and are stated into intermediate-high risk according to early mortality.
First group is prospective group, which contains patients recruited after approval of ethic committee of this study. Ethic committee was taken from both organization Ege University and The Ministry of Health-Türkiye.
Second group is retrospective group, which contains patients evaluated by EGEPET and received reduced dose thrombolytic treatment.
Third group is called as historical control group. This patients group were diagnosed and treated with anticoagulants not thrombolytic treatment before establishment of EGEPET.
First and second groups compose the thrombolytic group, third group create the anticoagulant group (control)
The investigators are going to collect data (clinical, laboratory and radiological variables) of these patients to get detailed clinical information.
The investigators will compare the thrombolytic group with anticoagulant group (control). The primary end-point is to evaluate 30-day mortality and secondary-end point are to detect in one year-mortality and complications.
The investigators will compare mortality and complication rates in both groups.
N0 hypothesis; In the intermediate-high risk group diagnosed with PE, there is an increased mortality rate in the patients treated with half-dose thrombolytic (Alteplase 50 mg) than our historical group or the literature.
N1 hypothesis; In the intermediate-high risk group diagnosed with PE, there is no an increased mortality rate in the patients treated with half-dose thrombolytic (Alteplase 50 mg) than our historical group or the literature.
- Conditions
- Pulmonary Embolism
- Being tested
- Tissue Plasminogen Activator, Alteplase, Low-molecular weight heparin
- Keywords
- Pulmonary Embolism, Pulmonary Embolism Response Teams, Thrombolytic Treatment, Anticoagulation Treatment, Mortality, Complication
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue Plasminogen Activator, AlteplaseDrug
Reduced dose (50 mg) Alteplase is used for the patients in the thrombolytic treatment group.
Low-molecular weight heparinDrug
Patients in the anticoagulation treatment group receive this treatment and do not receive thrombolytic treatment.
| Study group | Role | What they receive |
|---|---|---|
| Thrombolytic Treatment Group | These are the patients with intermediate-high riskPE and consulted by EGEPET. They received reduced dose thrombolytic treatment. Receives: Drug: Tissue Plasminogen Activator, Alteplase | |
| Anticoagulation Treatment Group | This group includes patients who diagnosed wit PE before the establishment of EGEPET. And these patients are classed into intermediate-high risk based on early mortality and received anticoagulation treatment, not thrombolytic treatment. Receives: Drug: Low-molecular weight heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
30 day Mortality
Includes 30-day mortality and contains all causes of death.
Measured: 30 day after diagnosis of pulmonary tromboembolism
Secondary outcomes (1)
1 year Mortality
Includes 1 year mortality and contains all causes of death.
Measured: 1 year after diagnosis of pulmonary tromboembolism
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start3 Jun 2022
- Primary completion3 Jun 2023 (estimated)
- Study completion3 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe 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
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pervin KORKMAZ, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05512702
- Sponsor's protocol ID
- 21-AKD-107
- Status last verified
- Aug 2022
- First submitted
- 22 Aug 2022
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mirambeaux R, Leon F, Bikdeli B, Morillo R, Barrios D, Mercedes E, Moores L, Tapson V, Yusen RD, Jimenez D. Intermediate-High Risk Pulmonary Embolism. TH Open. 2019 Dec 4;3(4):e356-e363. doi: 10.1055/s-0039-3401003. eCollection 2019 Oct.
PubMed 31815247Konstantinides SV, Meyer G, Becattini C, Bueno H, Geersing GJ, Harjola VP, Huisman MV, Humbert M, Jennings CS, Jimenez D, Kucher N, Lang IM, Lankeit M, Lorusso R, Mazzolai L, Meneveau N, Ni Ainle F, Prandoni P, Pruszczyk P, Righini M, Torbicki A, Van Belle E, Zamorano JL; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J. 2020 Jan 21;41(4):543-603. doi: 10.1093/eurheartj/ehz405. No abstract available.
PubMed 31504429Sharifi M, Bay C, Skrocki L, Rahimi F, Mehdipour M; "MOPETT" Investigators. Moderate pulmonary embolism treated with thrombolysis (from the "MOPETT" Trial). Am J Cardiol. 2013 Jan 15;111(2):273-7. doi: 10.1016/j.amjcard.2012.09.027. Epub 2012 Oct 24.
PubMed 23102885Meyer G, Vicaut E, Danays T, Agnelli G, Becattini C, Beyer-Westendorf J, Bluhmki E, Bouvaist H, Brenner B, Couturaud F, Dellas C, Empen K, Franca A, Galie N, Geibel A, Goldhaber SZ, Jimenez D, Kozak M, Kupatt C, Kucher N, Lang IM, Lankeit M, Meneveau N, Pacouret G, Palazzini M, Petris A, Pruszczyk P, Rugolotto M, Salvi A, Schellong S, Sebbane M, Sobkowicz B, Stefanovic BS, Thiele H, Torbicki A, Verschuren F, Konstantinides SV; PEITHO Investigators. Fibrinolysis for patients with intermediate-risk pulmonary embolism. N Engl J Med. 2014 Apr 10;370(15):1402-11. doi: 10.1056/NEJMoa1302097.
PubMed 24716681Wendelboe AM, Raskob GE. Global Burden of Thrombosis: Epidemiologic Aspects. Circ Res. 2016 Apr 29;118(9):1340-7. doi: 10.1161/CIRCRESAHA.115.306841.
PubMed 27126645
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Approach in Patients Diagnosed With Pulmonary Thromboembolism With Intermediate-High Risk Interms of Early Mortality After the Establisment of Ege Pulmonary Embolism Team
- ClinicalTrials.gov ID
- NCT05512702
- Acronym / sponsor ID
- 21-AKD-107
- Conditions
- Pulmonary Embolism
- Keywords
- Pulmonary Embolism, Pulmonary Embolism Response Teams, Thrombolytic Treatment, Anticoagulation Treatment, Mortality, Complication
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- 3 Jun 2023 (estimated)
- Study completion
- 3 Jun 2024 (estimated)
- First posted
- 23 Aug 2022 (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.
Pulmonary Embolism(PE) requires multidisciplinary approach as a highly morbid and mortal disease. This multidisciplinary approach creates clinical benefits in diagnostic and therapeutic process. And these benefits are pointed out in certain studies and guidelines. For these reasons, a Pulmonary Embolism Response Team (PERT) was established on 5 th November 2018 which is called as Ege Pulmonary Embolism Team (EGEPET) in our university.
In recent years, it is stated that the carefully use of thrombolytic in patients with intermediate-high risk PE based on early mortality classification. Some studies have reported that the use of thrombolytic may cause clinical benefits. But which used drug and which dose are not defined clearly yet.
After establishment of EGEPET, the investigators observed that patients with intermediate-high risk PE more receive reduced dose thrombolytic than the pre-EGEPET period. And the investigators aimed to compare treatment changes after and before the establishment of EGEPET. Also, the investigator will compare initial reduced dose thrombolytic therapy after EGEPET with initial anticoagulation therapy before EGEPET (historical group) in terms of mortality and complication.
As the reduced dose thrombolytic, Alteplase 50 mg is used in our hospital. Low-molecular weight heparin (LMWH), standard heparin and rarely Fondaparinux are used for anticoagulation therapy. Low-molecular weight heparin is generally applied for treatment, in case there is no contraindication.
Our primary end-point is to assess 30-day mortality and secondary-end points are to detect in one year-mortality and complications. The investigators will compare the mortality and complication rates in these groups.
N0 hypothesis; In the intermediate-high risk group diagnosed with PE, there is an increased mortality rate in the patients treated with half-dose thrombolytic (Alteplase 50 mg) than our historical group or the literature.
N1 hypothesis; In the intermediate-high risk group diagnosed with PE, there is no an increased mortality rate in the patients treated with half-dose thrombolytic (Alteplase 50 mg) than our historical group or the literature.
Detailed description
Pulmonary thromboembolism ranks 3rd among cardiovascular diseases in terms of mortality. Pulmonary Embolism (PE) is a challenging disease that requires rapid approach both in the diagnosis and treatment process. Due to the challenging nature of the disease, Pulmonary Embolism Response Teams (PERT) have emerged for quick intervention in patients with PE. In the management of PE, multidisciplinary approach that includes the branches of pulmonary diseases, cardiology, emergency medicine, cardiovascular surgery, anesthesiology and radiology provides clinical advantages. Therefore, a PERT was established and called Ege Pulmonary Embolism Team (EGEPET). EGEPET established on 5th of November 2018. This team contains specialists from Pulmonary Diseases, Cardiology, Emergency Medicine, Cardiovascular Surgery, Anesthesiology and Radiology Departments. EGEPET works during 7/24 as a response team. It has been stated in recent publications and pulmonary thromboembolism guidelines that the establishment of multidisciplinary study group which is similar to our group will be more effective in the diagnosis, treatment and follow-up processes of PE patients.
Specially, there are some different opinions for the treatment of Intermediate-High risk based on according to early mortality with PE patients. While some guidelines suggest initial anticoagulation treatment without thrombolytic treatment, some researchers state that thrombolytic treatment can be used in Intermediate-High risk patients. These researchers indicate that the careful use of thrombolytic can be improved in clinical situation of PE patients. The careful usage is meant to use reduced dose thrombolytic and to follow up the patients closely for bleeding complication.
In cases diagnosed with intermediate-high risk PE in related to early mortality, it has been seen that half-dose thrombolytics are given mostly in our daily life practice after EGEPET.
So, the investigators planned to evaluate the mortality and morbidity rates in the patients who were diagnosed with pulmonary thromboembolism with intermediate-high risk in terms of early mortality and who received half-dose thrombolytics according to the result of the EGEPET consultation.
50 mg Alteplase is used as thrombolytic treatment and, low-molecular weight heparin (LMWH), standard heparin and rarely Fondaparinux are used for initial anticoagulation treatment. Low-molecular weight heparin is generally applied for treatment, in case there is no contraindication.
This study is an observational drug study. Researchers of this study did not and will not intervene the treatment of patients. Treatment decision of the patients is decided by EGEPET physicians.
The investigators will compare the patients diagnosed with intermediate-high risk PE who received reduced dose thrombolytic which the decision is made by EGEPET with the other patients who did not get thrombolytic treatment in terms of mortality and morbidity.
The other patient group with intermediate-high risk PE will be created from our historical data to prevent to selection bias. Because, EGEPET offers generally reduced dose thrombolytic in intermediate-high risk PE patients. Otherwise, patients having high bleeding scores (e.g. RIETE bleeding score), multiple and severe comorbidities or patients who are quite old generally receive only anticoagulation treatment.
The patients assessed our study were classed into three groups. All of the patients have PE and are stated into intermediate-high risk according to early mortality.
First group is prospective group, which contains patients recruited after approval of ethic committee of this study. Ethic committee was taken from both organization Ege University and The Ministry of Health-Türkiye.
Second group is retrospective group, which contains patients evaluated by EGEPET and received reduced dose thrombolytic treatment.
Third group is called as historical control group. This patients group were diagnosed and treated with anticoagulants not thrombolytic treatment before establishment of EGEPET.
First and second groups compose the thrombolytic group, third group create the anticoagulant group (control)
The investigators are going to collect data (clinical, laboratory and radiological variables) of these patients to get detailed clinical information.
The investigators will compare the thrombolytic group with anticoagulant group (control). The primary end-point is to evaluate 30-day mortality and secondary-end point are to detect in one year-mortality and complications.
The investigators will compare mortality and complication rates in both groups.
N0 hypothesis; In the intermediate-high risk group diagnosed with PE, there is an increased mortality rate in the patients treated with half-dose thrombolytic (Alteplase 50 mg) than our historical group or the literature.
N1 hypothesis; In the intermediate-high risk group diagnosed with PE, there is no an increased mortality rate in the patients treated with half-dose thrombolytic (Alteplase 50 mg) than our historical group or the literature.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thrombolytic Treatment Group | – | Drug: Tissue Plasminogen Activator, AlteplaseThese are the patients with intermediate-high riskPE and consulted by EGEPET. They received reduced dose thrombolytic treatment. |
| Anticoagulation Treatment Group | – | Drug: Low-molecular weight heparinThis group includes patients who diagnosed wit PE before the establishment of EGEPET. And these patients are classed into intermediate-high risk based on early mortality and received anticoagulation treatment, not thrombolytic treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In this study, intermediate-high risk PE patients will divide whether receice thrombolytic treatment or not. And two group are going to compare in the context of mortality rate. We anticipate that 50 patients should be enough for statistically powerful study. We predict this number according to previous studies and power analyses.
Key inclusion criteria (1 listed)
- Patients which are in intermediate-high risk class ased on mortality in the ESC/ERS Pulmonary Embolism Risk Classification
Key exclusion criteria (2 listed)
- Unwillingness of patient to participate in the study
- The case is in the intermediate-high risk class, but there is an unstable disease that will affect mortality due to malignancy or general medical condition.
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 |
|---|---|---|
| Tissue Plasminogen Activator, AlteplaseReduced dose (50 mg) Alteplase is used for the patients in the thrombolytic treatment group. | Drug | Thrombolytic Treatment Group |
| Low-molecular weight heparinPatients in the anticoagulation treatment group receive this treatment and do not receive thrombolytic treatment. | Drug | Anticoagulation Treatment Group |
Primary outcome
30 day Mortality
Time frame: 30 day after diagnosis of pulmonary tromboembolism
Includes 30-day mortality and contains all causes of death.
1 secondary outcome
1 year Mortality
Time frame: 1 year after diagnosis of pulmonary tromboembolism
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- Background: PubMed 31815247Mirambeaux R, Leon F, Bikdeli B, Morillo R, Barrios D, Mercedes E, Moores L, Tapson V, Yusen RD, Jimenez D. Intermediate-High Risk Pulmonary Embolism. TH Open. 2019 Dec 4;3(4):e356-e363. doi: 10.1055/s-0039-3401003. eCollection 2019 Oct.
- Background: PubMed 31504429Konstantinides SV, Meyer G, Becattini C, Bueno H, Geersing GJ, Harjola VP, Huisman MV, Humbert M, Jennings CS, Jimenez D, Kucher N, Lang IM, Lankeit M, Lorusso R, Mazzolai L, Meneveau N, Ni Ainle F, Prandoni P, Pruszczyk P, Righini M, Torbicki A, Van Belle E, Zamorano JL; ESC Scientific Document Group. 2019 ESC Guidelines for the diagnosis and management of acute pulmonary embolism developed in collaboration with the European Respiratory Society (ERS). Eur Heart J. 2020 Jan 21;41(4):543-603. doi: 10.1093/eurheartj/ehz405. No abstract available.
- Background: PubMed 23102885Sharifi M, Bay C, Skrocki L, Rahimi F, Mehdipour M; "MOPETT" Investigators. Moderate pulmonary embolism treated with thrombolysis (from the "MOPETT" Trial). Am J Cardiol. 2013 Jan 15;111(2):273-7. doi: 10.1016/j.amjcard.2012.09.027. Epub 2012 Oct 24.
- Background: PubMed 24716681Meyer G, Vicaut E, Danays T, Agnelli G, Becattini C, Beyer-Westendorf J, Bluhmki E, Bouvaist H, Brenner B, Couturaud F, Dellas C, Empen K, Franca A, Galie N, Geibel A, Goldhaber SZ, Jimenez D, Kozak M, Kupatt C, Kucher N, Lang IM, Lankeit M, Meneveau N, Pacouret G, Palazzini M, Petris A, Pruszczyk P, Rugolotto M, Salvi A, Schellong S, Sebbane M, Sobkowicz B, Stefanovic BS, Thiele H, Torbicki A, Verschuren F, Konstantinides SV; PEITHO Investigators. Fibrinolysis for patients with intermediate-risk pulmonary embolism. N Engl J Med. 2014 Apr 10;370(15):1402-11. doi: 10.1056/NEJMoa1302097.
- Results publication: PubMed 27126645Wendelboe AM, Raskob GE. Global Burden of Thrombosis: Epidemiologic Aspects. Circ Res. 2016 Apr 29;118(9):1340-7. doi: 10.1161/CIRCRESAHA.115.306841.
- Individual participant dataSharing planned: No
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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.
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 Pulmonary Embolism, run by Ege University at 1 site in Turkey (Türkiye).
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 2 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 Sep 2022. 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 Turkey (Türkiye). 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30 day Mortality (time frame: 30 day after diagnosis of pulmonary tromboembolism). 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 NCT05512702, which also lists 5 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 Sep 2022.