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Reduced Dose Thrombolytic in Intermediate/High Risk Pulmonary Thromboembolism

NCT05512702 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2022-09-01

No results posted yet for this study

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

Interventions

DRUG

Tissue Plasminogen Activator, Alteplase

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

DRUG

Low-molecular weight heparin

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

Sponsors & Collaborators

  • Ege University

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-03
Primary Completion
2023-06-03
Completion
2024-06-03
FDA Drug
Yes

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05512702 on ClinicalTrials.gov