Has anyone been using Cathflo 1mg/1ml for catheter clearance vs the 2mg/2ml? Or is there literature to support?
Our pharmcacy has asked the question.
Thanks,
Julie
Julie Mijatovich, CRNI, VA-BC, BSN
Operational Lead Vascular Access Services
Parkview Hospital
We are a pediatric institution and follow the CHEST 2001 & 2004 guidelines: For patients < 10 Kg, administer 0.5mg diluted in NS to a volume equal to the internal volume of the lumen. For patients > 10 kg, administer concentration of 1mg/1ml, total volume to equal the internal volume of the lumen; Max dose is 2mg. For SIPs, the appropriate dose (0.5mg or 2mg) is diluted to 3mL in NS.
The manufacturer recommendations are to use 1mg/1ml concentration equal to 110% of the catheter volume, not to exceed 2mg/2ml for patients < 30kg; use 2mg/2ml for patients > 30 kg.
For patients greater than 10kg, the issue is really about the volume of the medication being adequate to actually fill the catheter lumen. 1ml may not be enough, but 2mg of the medication should not be exceeded.
Morgan Dunn, RN BSN CPON, Nationwide Children's Hospital
Hello to all my colleagues!
I saw this posting today & I'm very concerned! We must be practicing evidence-based medicine in vascular access & if you review the clinical trials for catheter declotting with Cathflo that Genentech conducted (COOL-1, COOL-2 for adults), THE DOSAGE IS 2 MG per lumen when blood return is sluggish, absent, fluctuating, or intermittent flow! Please URGE your pharmacists and nurses to read the clinical data! We must advocate for our patients with central venous catheters!!!! They are our patient's life lines!!!!!
When using 1 mg per lumen that's clotted with either a suspected partial fibrin tail or complete thrombotic occlusion you don't know what your treating and the dosage is SUB-STANDARD/SUBTHERAPEUTIC!!! YOU MUST USE 2 mg of Cathflo PER LUMEN!!! I can't stress this enough! Joint Commission is expecting facilities that depend on their accreditation to have IN PLACE evidence-based guidelines for CLABSI/CRBSI, and thrombotic catheter occlusions are a RISK FACTOR for CLABSI development! The longer we leave those fibrin tails/sheaths, the more we expose our patients to CLABSI development because that fibrin is a Nidus or medium for bacteria/fungi to grow & proliferate! ALSO, we MUST be checking for a blood return every 8 hours with a 10 ml syringe or larger & before any parenteral medication is administered or before blood draws EVEN with a continuous infusion!!
Our facility is a center of excellence for Central Venous Access. I have not had ONE CLABSI for 4+ years in all the CVADs I've placed & this is attributed in part to our nurses declotting when blood return is SLUGGISH and using best practice!!!! AlSO remind our pharmacists & other colleagues that central venous access device SALVAGE is preferred over catheter replacement according to INS, AVA, AACN, ONS etc~!!!! Salvage is accomplished by treating that CVAD with Cathflo when fibrin tail/sheath is suspected!
I have a CVAD policy, competency for Cathflo, & standing orders I'm willing to share if you email me!
Also look at the CAPS trial for pediatric dosing of Cathflo: For any patient 66 pounds or less, the dosage is 110% of the internal lumen volume of the catheter/central line!
Michele Biscossi, ACNP-BC, MS, RN, CNL
Acute Care Nurse Practitioner, VIR
Central venous access
[email protected]
518-633-1478
Wow! Well said Michelle!!! I hope all who have been writing into this website regarding de-clotting central lines in general will see not only your post but the one from Kathy Kokotis! Hopefully these posts will clear up some of the questions that so many nurses have with Cathflo administration and the standards of practice involved with central line catheter management!
On a side note....this is Patti from So Cal who helped you with the in-service at the LB-VA last year...great to "see" you again even if it is on a website :)
Would be great to see your policy, comp and standing orders for reference. My address is [email protected]
Hope to see you when you ever return to So Cal!
Patti
Julie:
There is no evidence to support a lower volume than 2 mg / 2ml dosing with the endpoint being the ability to obtain blood return
there is a paper published prior to the establishment of dosing in 2000 by Lee Vermillion a pharmacist from the University of Wisconsin. That study was performed prior to the large studies of over 1,000 adult and ped patients for the 2mg/2ml dosing. The FDA has cleared for market the 2mg/2ml dose. In the Lee Vemillion paper the endpoint was not the establishment of blood return but the establishement of the ability to infuse. A properly functioning device has the ability for free flowing blood return.
Bottom line there is no paper to support a lower dosage than 2 mg/2ml for the endpoint of blood return
Kathy Kokotis RN BS MBA
Well said Kathy!!!!!!!!!!
~Michele
Michele Biscossi, ACNP-BC, MS, RN, CNL
Thanks for info. Julie
If I am reading the posts correct 1mg/1ml and 2mg/2ml are the same concentration of medication the difference is in the amount used which should be 110% of the dwell volume for the catheter.
Rose Galyan RN, BSN, CRNI
Speciality Practice Nurse
Vascular Access Team
Indiana University Hospital Bloomington
[email protected]
I just learned that our hospital admitted a patient over the weekend where the patient told the Vascular Access nurse that the dialysis unit was locking her catheter with Alteplase. Sure enough, physician gave an order for 1mg mixed in 1.7ml sterile water to fill the catheter. I questioned this practice and was told that they have been doing this with select patients to successfully keep their catheters free from fibrin build-up which was occurring with 1000 unit heparin lock. I was also told that it works! I know this is not the standard dosing nor the indication. The dialysis unit knows this as well. What to do?
I also believe that infusional Alteplase is off-label, sooooo......is it the same or not?
While this may be an off-label use, it is supported by at least one clinical study from Canada. Off-label use means that the manufacture can not promote the product to be used in a manner that is not indicated by the product labeling. If asked about any off-label use, they can supply a study pertaining to the practice in question but can not provide this unless asked. It is a well-known fact that off-label use occurs with many drugs and devices on a daily basis. The FDA does not control clinical practice, only what a manufacturer can say and do to promote their product. So it is up to the healthcare professionals to make an assessment about this off-label use and determine if this is a safe and efficacious practice to do. In the case of using alteplase as a locking solution or as a low-dose infusion, I believe that there are definitely appropriate times and patients where these should be used. This is called evidence based practice!! Lynn
Lynn Hadaway, M.Ed., RN, NPD-BC, CRNI
Lynn Hadaway Associates, Inc.
PO Box 10
Milner, GA 30257
Website http://www.hadawayassociates.com
Office Phone 770-358-7861
The clinical trials were done using a 2 mg/ 2ml dose of alteplase (now Cathflo) for efficacy rates of 85 to 88% with up to 2 doses. If you're talking about intraluminal occlusions, with an internal lumen size of less than 1 ml, then yes, a 1 mg /1 ml dose will likely work. However, the majority of catheter occlusions are extraluminal and the studies used 2mg in 2 mls. You have to allow the alteplase to get outside the catheter to all of the thrombus or fibrin outside the catheter tip. You might create a hole or dissolve part of the fibrin at the catheter tip, enough to get blood return for awhile, but it's very hard to say if this problem will recur because not enough drug was instilled. A subset of patients (346) were analyzed by the clinical trials out to 30 days, and there was a patency rate 73.7%. Many drugs are used for off-label use, but it's important to understand the clinical outcomes with the standard dosages in order to make a judgment if half the dose still makes sense.
Nadine Nakazawa, RN, BS, VA-BC