Surgery Versus Fibrinolytic Therapy for Left-sided Prosthetic Heart Valve Thrombosis
Status:
Unknown status
Trial end date:
2019-03-01
Target enrollment:
Participant gender:
Summary
Malfunction of mechanical heart valves due to clot formation is a potentially devastating
complication. It often results in heart failure, death or stroke. This condition occurs
frequently in patients with mechanical valves in developing countries because they are unable
to monitor and adjust the dose of blood thinning medications. The best treatment modality for
the treatment of patients with this condition is not known. There is no reliable data from
clinical trials to guide treatment and there are no firm guidelines. Treatment with
clot-busting drugs is most commonly used because these drugs (e.g., streptokinase) are
readily available, cheap, and easy to use. However, this treatment is associated with high
rates of treatment-related side-effects (death, life-threatening bleeding and stroke).
Moreover, some recent studies suggest that clot-busting drugs may not be as efficacious in
restoring valve function, as previously believed. Emergency surgery is less often used
because it is more expensive and the required facilities and manpower are not available at
all times at all places. But there is evidence to suggest that surgery results in better
success rates with a lower risk of bleeding and stroke. Well-designed prospective randomised
trials (the "gold-standard" for reliable evidence) comparing the efficacy, safety and
cost-effectiveness of the two modalities, are needed to help doctors in developing countries
make informed decisions when treating patients with clotted mechanical heart valves. The
investigators propose to perform a randomised controlled trial comparing emergency surgery
with treatment with clot-busting agents in patients with clotted mechanical valves. The study
will be conducted over 4 years at a single, university hospital in a developing country. This
study will determine how often patients who are treated with surgery will be discharged from
hospital, with completely restored valve function, without having suffered a stroke or
life-threatening bleeding, when compared to those who received clot-busting drugs. The
investigators will also find out which of the treatments is safe and cost-effective.
Phase:
Phase 3
Details
Lead Sponsor:
All India Institute of Medical Sciences, New Delhi