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Annual incidence of PVT for mechanical valves is 0.3 - 1.3% patient-yrs. First postoperative year is marked by a 24% incidence of thrombosis. Stable incidence between the second to fourth years (~ 15%), and a subsequent decrease afterward. Mortality rates of Re-do Surgery have been reported to be from 6% to 69% (average 12%) Thrombolytic therapy as a First-line strategy is being used with successful outcomes. To Study the Efficacy & Safety of Low Dose (25 mg) Ultra-slow (24 hr) Infusion of Alteplase Without Bolus (max 72 hrs) over Slow (24hr) Infusion of 25 lac units Streptokinase (2.5 lac 1st hr → 1 lac /hr for 23 hrs) (max 48 hrs) in Mechanical PVT.
Objectives :
Primary :
To compare the success rate of USLD Alteplase thrombolysis over Streptokinase To compare the complication rates (minor + non-fatal major + fatal) in both the study groups
Secondary:
To study the clinical profile of patients presenting with Mechanical PVT. Single Centre Open Label Randomized Controlled Trial Sample Size : 100 (50 each) Follow up : Till Hospital Discharge Pt randomized as per Computer Generated Random Number Started on Inj Heparin Infusion till initiation of Thrombolysis. Repeat 2D Echo at 6 Hrs, 12 Hrs and 24 Hrs Interval & as required. Repeat Fluoroscopy / TEE if Echocardiographic evidence of improvement in gradient or moving leaflets / at 24 hrs interval.
Extended Thrombolysis with STK (max 48 hrs) / Alteplase (Max 72 hrs) Restarting of Heparin Infusion In between time lags for next continuation of Thrombolysis / Surgery/ attaining Therapeutic INR Post-thrombolysis Follow up till Discharge for Outcome
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alteplase | Active Comparator | Low Dose (25 mg) Ultra-slow (24 hr) Infusion of Alteplase Without Bolus (max 72 hrs) |
|
| Streptokinase | Active Comparator | Slow (24hr) Infusion of 25 lac units Streptokinase (2.5 lac 1st hr → 1 lac /hr for 23 hrs) (max 48 hrs) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alteplase | Drug | Low Dose (25 mg) Ultra-slow (24 hr) Infusion of Alteplase Without Bolus (max 72 hrs) |
|
| Measure | Description | Time Frame |
|---|---|---|
| complication rates | To compare the success rate of USLD Alteplase thrombolysis over Streptokinase To compare the complication rates (minor + non-fatal major + fatal) in both the study groups | 30 days |
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patients with Written Informed Consent All adult patients of Mechanical PVT, Patient planned for Thrombolysis as first option as per common decision of Treating Cardiologist and CVTS Team.
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| Name | Affiliation | Role |
|---|---|---|
| Sibasis Sahoo, DM | U. N. Mehta Institute of Cardiology and Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr.Sibasis Sahoo | Ahmedabad | Gujarat | 380016 | India |
Patients information don't want to disclose
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| streptokinase | Drug | Slow (24hr) Infusion of 25 lac units Streptokinase (2.5 lac 1st hr → 1 lac /hr for 23 hrs) (max 48 hrs) |
|
| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| D013300 | Streptokinase |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |
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