Reduced Dose Thrombolytic in Intermediate/High Risk Pulmonary Thromboembolism

NCT05512702 | Unknown DMC FDA Drug

• 1 other identifier: 21-AKD-107
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pulmonary Embolism

Keywords

Pulmonary Embolism; Pulmonary Embolism Response Teams; Thrombolytic Treatment; Anticoagulation Treatment; Mortality; Complication

Outcome Measures

Primary Outcomes (1)

• 30 day Mortality

  Includes 30-day mortality and contains all causes of death.

  30 day after diagnosis of pulmonary tromboembolism

Secondary Outcomes (1)

• 1 year Mortality

  1 year after diagnosis of pulmonary tromboembolism

Study Arms (2)

Thrombolytic Treatment Group

These are the patients with intermediate-high riskPE and consulted by EGEPET. They received reduced dose thrombolytic treatment.

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.

Drug: Low-molecular weight heparin

Interventions

Tissue Plasminogen Activator, Alteplase DRUG

Reduced dose (50 mg) Alteplase is used for the patients in the thrombolytic treatment group.

Thrombolytic Treatment Group

Low-molecular weight heparin DRUG

Patients in the anticoagulation treatment group receive this treatment and do not receive thrombolytic treatment.

Anticoagulation Treatment Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Patients which are in intermediate-high risk class ased on mortality in the ESC/ERS Pulmonary Embolism Risk Classification

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University

Izmir, Bornova/İzmir, 35100, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• 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.

  PMID: 31815247 BACKGROUND

• Konstantinides 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.

  PMID: 31504429 BACKGROUND

• Sharifi 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.

  PMID: 23102885 BACKGROUND

• Meyer 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.

  PMID: 24716681 BACKGROUND

• Wendelboe AM, Raskob GE. Global Burden of Thrombosis: Epidemiologic Aspects. Circ Res. 2016 Apr 29;118(9):1340-7. doi: 10.1161/CIRCRESAHA.115.306841.

  PMID: 27126645 RESULT

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Tissue Plasminogen Activator; Dalteparin

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Serine Endopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Serine Proteases; Plasminogen Activators; Blood Coagulation Factors; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Biological Factors; Heparin, Low-Molecular-Weight; Heparin; Glycosaminoglycans; Polysaccharides; Carbohydrates

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associated Professor

Study Record Dates

• First Submitted: August 22, 2022
• First Posted: August 23, 2022
• Study Start: June 3, 2022
• Primary Completion: June 3, 2023
• Study Completion: June 3, 2024
• Last Updated: September 1, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)