The Perioperative Management of Anti-thrombotic Drug Registry
Status: | Recruiting |
---|---|
Conditions: | Hospital |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 10/5/2018 |
Start Date: | January 31, 2018 |
End Date: | January 31, 2028 |
Contact: | Subhash Banerjee, MD |
Email: | subhash.banerjee@UTSouthwestern.edu |
Phone: | 2148571608 |
The purpose of the study is to investigate contemporary antiplatelet therapy management of
patients referred for non-cardiac and cardiac surgical procedures while on chronic therapy
with antiplatelet and/or anticoagulant drugs. These medications are routinely prescribed to
patients following percutaneous coronary interventions (PCI), known diagnosis of atrial
fibrillation, prosthetic heart valves, transcatheter aortic valve procedures, pulmonary
embolism, deep vein thrombosis, peripheral artery revascularization procedures etc. This is a
highly relevant and understudied clinical area with no randomized clinical trials or
large-scale prospective evidence, except for bridging data with unfractionated heparin (UFH).
Most recommendations and guidelines are based on consensus expert opinion. While post-PCI
patients, especially those treated with coronary stents are placed on dual antiplatelet
agents such as aspirin and P2Y12 blocking agents, performing surgery while on these agents
increase the risk of hemorrhagic complications, discontinuation or interruption of dual
antiplatelet therapy (DAPT) has been associated with adverse ischemic outcomes secondary to
myocardial infarction (MI) and stent thrombosis (ST). Moreover, there is only no clear
consensus regarding continuation of aspirin perioperatively in these patients. As in the case
of PCI, similar arguments for juxtaposed risks (thrombosis vs. bleeding) can be made for a
myriad of clinical situations where chronic (≥45 days) use antiplatelet and anticoagulant
medication (together referred to as antithrombotic drugs) are indicated. In addition, there
are many procedures and surgeries with different bleeding and ischemic risks that cannot be
studies through dedicated randomized studies and a registry collection of such information
could provide valuable guidance to providers and patients worldwide.
patients referred for non-cardiac and cardiac surgical procedures while on chronic therapy
with antiplatelet and/or anticoagulant drugs. These medications are routinely prescribed to
patients following percutaneous coronary interventions (PCI), known diagnosis of atrial
fibrillation, prosthetic heart valves, transcatheter aortic valve procedures, pulmonary
embolism, deep vein thrombosis, peripheral artery revascularization procedures etc. This is a
highly relevant and understudied clinical area with no randomized clinical trials or
large-scale prospective evidence, except for bridging data with unfractionated heparin (UFH).
Most recommendations and guidelines are based on consensus expert opinion. While post-PCI
patients, especially those treated with coronary stents are placed on dual antiplatelet
agents such as aspirin and P2Y12 blocking agents, performing surgery while on these agents
increase the risk of hemorrhagic complications, discontinuation or interruption of dual
antiplatelet therapy (DAPT) has been associated with adverse ischemic outcomes secondary to
myocardial infarction (MI) and stent thrombosis (ST). Moreover, there is only no clear
consensus regarding continuation of aspirin perioperatively in these patients. As in the case
of PCI, similar arguments for juxtaposed risks (thrombosis vs. bleeding) can be made for a
myriad of clinical situations where chronic (≥45 days) use antiplatelet and anticoagulant
medication (together referred to as antithrombotic drugs) are indicated. In addition, there
are many procedures and surgeries with different bleeding and ischemic risks that cannot be
studies through dedicated randomized studies and a registry collection of such information
could provide valuable guidance to providers and patients worldwide.
Inclusion Criteria:
- Treatment with antiplatelet and/or anticoagulant medications for ≥45 days prior to the
date of NCS.
- Patients with planned, urgent or emergent cardiac or non-cardiac surgery or procedure
(CNCS)
Exclusion Criteria:
We found this trial at
2
sites
2201 Inwood Rd
Dallas, Texas 75235
Dallas, Texas 75235
(214) 645-8300
Phone: 214-857-3048
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Dallas, Texas 75216
Principal Investigator: Houman Khalili, MD
Phone: 214-857-2206
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