The pooled analysis confirmed that earlier treatment of stroke patients is associated with a more favorable outcome. Based on the numbers needed to treat (NNT) ratio, for every 8 patients treated with alteplase, 1 patient has excellent or complete recovery, and for every 15 patients treated, 1 patient has a symptomatic intracranial hemorrhage.
Full Answer
What are the indications for alteplase?
If the symptoms do not resolve, a stroke most likely has occurred. Symptoms of TIA include: confusion, weakness, lethargy, and loss of function to one side of the body. Risk factors for TIA include vascular disease, smoking, high blood pressure, high cholesterol, and diabetes. Treatment depends upon the severity of the TIA, and whether it resolves.
When did the prescribing information for alteplase change?
Sep 29, 2021 · Alteplase (tPA) is a powerful thrombolytic agent used in the lysis of acute thromboembolism. FDA-approved indications for alteplase include pulmonary embolism, myocardial infarction with ST-segment elevation (STEMI), ischemic stroke when given within 3 hours of the start of symptoms, and re-establishment of patency in occluded intravenous (IV) …
How does alteplase affect bleeding?
Jun 16, 2017 · Low- Versus Standard-Dose Alteplase in Patients on Prior Antiplatelet Therapy 1877 Background and Purpose—Many patients receiving thrombolysis for acute ischemic stroke are on prior antiplatelet therapy (APT), which may increase symptomatic intracerebral hemorrhage risk. In a prespecified subgroup analysis, we report
Who should not be treated with alteplase?
Apr 10, 2022 · Patients must speak with a health care provider for complete information about their health, medical questions, and treatment options, including any risks or benefits regarding use of medications. This information does not endorse any treatments or medications as safe, effective, or approved for treating a specific patient.
What must be considered before using alteplase to treat a patient with symptoms of stroke?
What is the window of opportunity after stroke symptoms begin in order to receive thrombolytic treatment for ischemic stroke?
How long after symptoms can you give tPA?
What are treatment Administration guidelines for alteplase?
- 10% of the total treatment dose should be administered as an initial bolus over 1 minute.
- The remaining treatment dose should be infused intravenously over 60 minutes.
Which types of patients should benefit from reperfusion therapy with alteplase?
Who is a candidate for thrombolytic therapy?
What are contraindications for tPA?
- Significant head trauma or prior stroke in the previous 3 months.
- Symptoms suggest subarachnoid hemorrhage.
- Arterial puncture at a noncompressible site in previous 7 days.
- History of previous intracranial hemorrhage.
- Intracranial neoplasm, AVM, or an aneurysm.
- Recent intracranial or intraspinal surgery.
Who is not a candidate for tPA?
Arterial puncture at a noncompressible site in previous 7 days. History of previous intracranial hemorrhage. Intracranial neoplasm, AVM, or an aneurysm. Recent intracranial or intraspinal surgery.May 12, 2021
Is Plavix a contraindication for tPA?
When do you administer alteplase?
What signs and symptoms would alert you to the possible presence of an intracerebral hemorrhage during the tPA infusion?
Is seizure a contraindication for tPA?
What are the side effects of alteplase?
The most common and serious side effect of alteplase is bleeding. Minor bleeding is more common, but significant bleeding such as into the brain (intracranial hemorrhage) or fatal bleeding also occurs. Other important side effects include: Nausea. Vomiting.
What is Alteplase used for?
Alteplase is used to treat persons with heart attacks (acute myocardial infarctions), strokes, chest pain at rest (unstable angina), blood clots in the lungs (pulmonary thrombosis or embolism), and other less common conditions involving blood clots. It also is used for clearing blood clots from blocked venous catheters.
What is the enzyme that causes blood clots to dissolve?
Alteplase is an enzyme that occurs naturally in man and causes blood clots to dissolve. It is a man-made protein manufactured by recombinant DNA technology. The naturally occurring protein, known as tissue plasminogen activator (TPA), is made by ovarian cells from the Chinese hamster.
How long does Alteplase take to work?
Heart attack: For heart attacks the recommended dose is a 15 mg injection followed by 50 mg or 0.75 mg/kg (up to 50 mg) infused over 30 minutes then 35 mg or 0.5 mg/kg (up to 35 mg) over 60 minutes. The total dose is 100 mg.
How to report side effects of prescription drugs?
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
When was Alteplase first approved?
When was alteplase (TPA, Activase, Cathflo Activase) approved by the FDA? Alteplase was first approved for heart attacks in 1987. In 1996, it was approved for strokes.
Does Alteplase harm rabbits?
Alteplase has been shown to cause damage to embryos of rabbits. No damage has been reported in humans. Doctors must carefully balance potential risks and possible benefits when prescribing alteplase to pregnant women. It is not known whether alteplase passes into breast milk.
What is the FDA approved indication for Alteplase?
FDA-approved indications for alteplase include pulmonary embolism, myocardial infarction with ST-segment elevation (STEMI), ischemic stroke when given within 3 hours of the start of symptoms, and re-establishment of patency in occluded intravenous (IV) catheters.
What is alteplase used for?
Alteplase (tPA) is a powerful thrombolytic agent used in the lysis of acute thromboembolism. FDA-approved indications for alteplase include pulmonary embolism, myocardial infarction with ST-segment elevation (STEMI), ischemic stroke when given within 3 hours of the start of symptoms, and re-establishment of patency in occluded intravenous (IV) catheters. There are also off-label indications. This activity outlines the indications, mechanism of action, methods of administration, important adverse effects, contraindications, toxicity, and monitoring, of tPA therapy with agents like alteplase, so providers can direct patient therapy where they are indicated as part of the interprofessional team.
What is the bleeding rate for alteplase?
Bleeding associated with alteplase therapy can be divided into two broad categories. Internal bleeding includes intracranial bleeding (0.4% to 15.4%), retroperitoneal bleeding (less than 1%), gastrointestinal (GI) bleeding (5%), genitourinary bleeding (4%), and respiratory bleeding. Superficial or surface bleeding is observed mainly at invaded or disturbed sites such as venous cutdowns, arterial punctures, and recent surgical intervention sites. Less serious spontaneous bleeding includes ecchymosis (1%), gingival bleeding (less than 1%), and epistaxis (less than 1%). In clinical studies of adult patients with acute ischemic stroke (n = 624), a higher incidence of intracranial bleeding, especially symptomatic intracranial bleeding, was seen in patients receiving alteplase compared to placebo (total intracranial bleeding 15.4% versus 6.4%, p < 0.01; symptomatic intracranial bleeding 8% versus 1.3%, p < 0.01). However, there was no increase in the incidence of 90-day mortality or severe disability in patients receiving alteplase. Studies indicate that the incidence of intracranial bleeding is dose-related, with the greatest percentage occurring at a dosage of 150 mg (1.3%) compared to 100 mg (0.4%). Rates of adverse events, including bleeding, correlate to the total exposure of tPA.
How does Alteplase work?
Alteplase acts within the endogenous fibrinolytic cascade to convert plasminogen to plasmin by hydrolyzing the arginine-valine bond in plasminogen. The activated plasmin then degrades fibrin and fibrinogen, allowing for the dissolution of the clot and re-establishment of blood flow. [4][5]
What blood test is needed before TPA?
Ischemic Stroke:The only blood test that is necessary before tPA usage is the blood glucose level. If the patient is on anticoagulation like coumadin, then only we should do PT, PTT, and INR, etc. The benefit of tPA depends a lot on time. The sooner the patient receives tPA; the better are the outcomes.
Can TPA cause cardiac dysrhythmia?
Cardiac dysrhythmias may occur when tPA is administered for NSTEMI and is related to the re-establishment of tissue perfusion rather than drug exposure.
Is TPA specific to the indication?
The dosing and administration of tPA are specific to the indication.
What to do if you have side effects that don't go away?
Call your doctor or get medical help if you have any side effects that bother you or do not go away. These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
What to do if you think you have an overdose?
If you have any questions about this drug, please talk with your doctor, nurse, pharmacist, or other health care provider. If you think there has been an overdose, call your poison control center or get medical care right away.
How old is too old to take alteplase?
Therefore, in the 0- to 3-hour window, alteplase is recommended for patients both younger and older than 80 years old. Patients in the 0- to 3-hour window with severe strokes have a higher risk of hemorrhagic transformation than patients with more mild strokes, but these patients still benefit from alteplase.
What should treatment decisions account for?
Treatment decisions should account for patient and family preferences and goals of care . In patients with psychogenic symptoms, conversion disorder, or malingering treated with alteplase, the risk of symptomatic intracranial hemorrhage is low.
Can alteplase be used for stroke patients?
In patients who have had a major surgery within the preceding 2 weeks, alteplase can be considered, but the potential reduction in stroke-related disability should be weighed against the risk of hemorrhage at the surgical site. Discussions with the surgical service in this setting can be helpful.
Can you take alteplase with warfarin?
In patients taking warfarin who have an ischemic stroke, treatment with alteplase may be reasonable if the INR is ≤1.7. The use of alteplase in patients taking: warfarin, with an INR of >1.7; a direct thrombin inhibitor; or a direct factor Xa inhibitor is not recommended.
Can alteplase be used for ischemic stroke?
In patients who have an ischemic stroke as a complication of cardiac or cerebral angiography, treatment with alteplase is reasonable. The use of alteplase to treat patients with ischemic stroke caused by endocarditis is not recommended because of an increased risk of intracranial hemorrhage.
How to hang activase vial?
Peel the clear plastic hanger from the vial label. Hang the Activase vial from the resulting loop.
When to remove treatment dose from Y site injection port?
Remove the treatment dose from the Y-site injection port on the infusion line after the infusion set is primed.
Where to insert spike end of activase?
Insert the spike end of an infusion set through the center of the stopper of the vial of reconstituted Activase, using the same puncture site made by the transfer device.
What to inspect before administration of a solution?
Inspect the solution for particulate matter and discoloration prior to administration.
Can you add other medications to Activase?
Do not add other medication to solutions containing Activase.
Can activase cause ecchymosis?
Activase is for intravenous administration only. Extravasation of Activase infusion can cause ecchymosis or inflammation . If extravasation occurs, terminate the infusion at that IV site and apply local therapy.