Lmwh Bridging Vs Placebo Pilot

[warrenr]

PERIOP 2 - A Safety and Effectiveness Study of LMWH Bridging Therapy Versus Placebo Bridging Therapy for Patients on Long Term Warfarin and Require Temporary Interruption of Their Warfarin.


http://clinicaltrials.gov/ct/show/NCT00432796;jsessionid=5D26271901A82E84291FF9D0EFE4774B?order=15

Don't think I would won't to be in the Placebo Group. Of interesting note is the fact that all patients will have perioperative bridging. Dalteparin, a LMWH, will be administered at 200 IU/kg sc early in the morning for the three days prior to, but not including the day of, the procedure except on the day prior to surgery the dose will be 100 I.U./kg given 24 hours preoperatively. Warfarin will be resumed the evening of the procedure.

The study will only be looking at bridging/placebo during the post operative period.

 

[lance]

Bridging--placebo--warfarin!!! Say it isn't so.

Bridging--placebo--warfarin!!! Say it isn't so.

Thanks for the link.

All participating hospitals are in Canada.

I've also noticed that preoperatively LMWH is to be administered once per day and the final dose reduced by 50%. I thought it was effective for 12 hours requiring twice daily doses. That's what I was told last year when I had to be bridged. They are looking at the postoperative procedure only--the damage could already be happening. It's scary.

Oh to be a fly on the wall when practitioners are pitching the merits of placebo therapy to patients already at high risk for strokes. It seems their fear of potential patient bleeding is unlimited. I'd really like to know what information "Informed consent" includes. Lawyers have been busy with that one, that's for sure. Hospitals are blameless.

 

[Guest]

I hope that they are paying the participants very well.

 

[lance]

Benefits to immediate family

Benefits to immediate family

If patients are paid to participate in this double blind study then payments could be called survivor benefits, insurance for life-long nursing home care--something along those lines but somehow I just don't believe that "informed consent" will be for any advantage to anyone except the hospital's legal department.

Exclusion criteria include patients with "Multiple prosthetic valves or Starr-Edwards valves or prosthetic valves with a history of stroke or TIA. Is this their way of acknowledging the problems related to the valve withdrawn from the market in 2000. You know the valve I refer to--it was approved after all--that being their only comment.

Although they are not actively recruiting I'm not surprised that 3 of the 7 hospitals mentioned in this paper are associated with that hospital in Hamilton.