PhD Scientific Days 2024

Budapest, 9-10 July 2024

Health Sciences III.

Viscoelastometry guided thrombolysis therapy for pulmonary embolism - new protocol: a single-center randomised controlled trial

Author(s)

Stubnya János Domonkos1, András Kállai1, Anna Párkányi1, Máté Berczi1, Dalma Skultéti1, Hanna Szász1, Gergely Szombath2, Adrienne Fehér3, János Gál1, János Fazakas1
1: Semmelweis University, Department of Anaesthesiology and Intensive Therapy
2: Semmelweis University, Department of Internal Medicine and Haematology
3: Semmelweis University, Department of Laboratory Medicine

Text of the abstract

Introduction: According to the protocol of the ESC, systemic thrombolysis therapy (STT) for the treatment of acute pulmonary embolism (PE) is recommended only in the high-risk group, following a treatment regimen of 100 mg rt-PA over 2 hours. Based on the literature, it can be stated that with this dose, there is a 13.8% and a 3.8% probability of severe and intracranial bleeding occurrence and an 8% incidence of unsuccessful STT.
Aim: To develop a safer, more effective, time-extended, ClotPro® viscoelastic test-guided STT for treating PE.
Method: Adult patients diagnosed with PE and classified into the high or intermediate-high risk groups were enrolled in a prospective randomised interventional clinical trial with ethical approval number 65187-5/2021/EÜIG conducted at the SE-AITK between 17/12/2021 and 11/09/2023. In both groups, 7 viscoelastic tests were performed hourly during thrombolysis.
In the ClotPro®-guided group (CPG), the rt-PA dose was adjusted according to the viscolestomety results, and fibrinogen was supplemented as needed to prevent coagulopathy. Signs of right ventricular dysfunction were monitored every two hours by echocardiography, and thrombolysis was discontinued upon their disappearance. In the control group (CG), the treatment protocol by the ESC was followed.
Result: A total of 33 subjects were enrolled in the study, of which 12 cases were excluded, CltoPro-guided treatment was applied in 13 cases, and the control protocol was followed in 8 cases. In the CPG, the mean length of treatment and the administered rt-PA dose were 8.82 hours and 32.47 mg. Fibrinogen replacement was performed in 5 patients. Severe bleeding complications occurred in 2 cases in the CG and 1 case in the CPG. In the CPG, right ventricular dysfunction resolved in all cases except for one patient with chronic pulmonary hypertension, while persistently occurred in 2 patients in the CG. Severe coagulopathy was observed multiple times in the CG. Following the discontinuation of STT in the CPG, the effect of rt-PA ceased within 10 minutes, whereas it persisted longer in the CG.
Conclusion: Based on our findings, it is likely that the extended, ClotPro®-guided STT for PE that we have developed seems to be more effective and safer and also allows for a reduction in the quantity of rt-PA used compared to current recommendations.
Funding: DiaCare Solution Kft. – ClotPro® tests