http://www.globalregina.com/federal+gov ... story.html
Now, the federal government has made another step towards their own trial here at home. A research team has been chosen and is now awaiting approval by an ethics committee.
“Once the approval has been given, which we don't expect will take too long, the funding can be released and the researchers can begin their work which we expect to begin in the fall of this year,” explained Tom Lukiwski, Member of Parliament for Regina Lumsden-Lake Centre.
The national study is co-sponsored by the MS Society of Canada who have donated half a million dollars to phase one and two of the trial.
“Phase one trials are really to determine safety,” said Janet Nicolson with the Saskatchewan branch of the MS Society of Canada. “We have seen cases across the world where people who’ve gone for CCSVI, Liberation Therapy, have seen complications with that and we really want to minimize that risk if this procedure is approved in Canada.”
So they are beginning with phase one, to determine safety?
I am pretty well versed in complications and there are things that can be done to minimize complications:
1 - use IVUS to diagnose stenoses and determine sizing of balloons
2 - prescribe true anticoagulants, and not antiplatelets along like aspirin or Plavix, post-procedure
3 - do not exceed vein size by more than about 10% when ballooning
4 - keep duration of ballooning short to minimize time that the vein is cut off from its own blood supply but repeat if necessary
5 - use high pressure balloons only if properly sized according to the measurements of the vein as measured by IVUS
6 - have a one-month doppler ultrasound to check for clotting; and if clotting is found, have a second procedure to manually remove clot
7 - hypoplasias can be left alone due to their likelihood of clotting if treated
8 - avoid perforations of the veins by using a softer guidewire, backing off quickly, and going slow
9 - do not compress the femoral vein entry point excessively hard or for too long, as clots can happen there
10 - keep stent use to a minimum, when absolutely necessary, which should be less than 5% of the time
11 - treat patients locally to better facilitate follow-up care
12 - in the upper jugular, do not balloon stenoses against bone, because it can damage the vein against the bone
13 - do not stent a physiological narrowing, where if it expands, the stent can migrate
14 - do not begin the trial with a doctor who has treated fewer than fifty patients, because there is a learning curve to the procedure
15 - exercise extra caution if the patient has a clotting disorder
16 - what did I miss?