Comparison of fast versus ultraslow infusion of thrombolytic regimen in patients with mechanical prosthetic valve thrombosis
Design
Two parallel groups randomized trial with blinded outcome assessment
Settings and conduct
The trial will be held in a hospital setting (Rajaie Cardiovascular Medical and Research center) on patients with mechanical prosthetic valve thrombosis . Patients will be randomized via central web based method into two interventional groups with two different thrombolytic regimen. Treating physician and patients will not be blinded. Thrombus resolution and degree of valve openingwill be evaluated by echocardiography after thrombolytic therapy. Also thrombolytic complication will be evaluated during hospitalization.
Participants/Inclusion and exclusion criteria
Inclusion criteria: provision of signed and dated informed consent form; patients with prosthetic mechanical valve thrombosis approved by echocardiography; men and women ≥ 18 year-old.
Exclusion criteria: contraindication of thrombolytic therapy; dyspnea of functional class 4; thrombus size larger than 0.8 cm2.
Intervention groups
In this study there are two interventional groups: first group: patients will receive fast thrombolytic regimen. Second group: patients will receive ultra slow thrombolytic regimen.
Comparison of fast versus ultraslow infusion of thrombolytic in patients with mechanical prosthetic valve thrombosis- A randomized controlled trial
Public title
Thrombolytic in mechanical prosthetic valve thrombosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Provision of signed and dated informed consent form
Patients with prosthetic mechanical valve thrombosis approved by echocardiography
Men and women ≥ 18 year-old
Exclusion criteria:
Contraindication of thrombolytic therapy
Dyspnea of functional class 4
Thrombus size larger than 0.8 cm2
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be performed via permuted block randomization method. Allocation will be generated via a web based system and consequently concealment will be central using computer software. Unit of randomization will be individual patients and no stratification will be applied.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Rajaie Cardiovascular Medical and Research Center Ethic committee