To Compare the Efficacy & Safety of Ultra-Slow (24 hr) Low Dose (25 mg) Infusion of Alteplase Over Slow (24hr) Infusion of Streptokinase in Mechanical Prosthetic Valve Thrombosis

Summary

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

Timeline

Start

2024-11-01

Primary completion

2025-12-31

Completion

2025-12-31

Drugs

Indications

No indication recorded.