Blogs

blood collection volume and ICF

By Ying Lu posted 09-16-2010 06:27 PM

  
A study requires collecting 2 ml plasma and the sponsor's detailed procedure calls for drawing 2 times the requested volume of blood. The IRB requires to state the volume of blood to be collected in both the protocol and the ICF. In general, whole blood contains about 55% of plasma. What volume of blood do we need collect, 4 ml or 6 ml?
thanks
3 comments
23 views

Permalink

https://community.acrpnet.org/blogs/ying-lu/2010/09/16/blood-collection-volume-and-icf

Comments

Alona Waldrop-Kelly
10-13-2010 10:06 AM

Getting 2ml of plasma from a 4ml tube is tight, no room for error or high HCTs. However, certain patient populations have low HCTs which gives more plasma, like elderly. Low iron and dehydration will affect plasma volume. maybe 4mls would work for certain trials, but the best is to go with the 6ml to be certain that the testing can take place as directed in the protocol. If limited to the 4ml tube, make sure the patients are adequately hydrated and the centrifuge is operating as required.

Natalie Buettner
09-28-2010 11:51 AM

I would go ahead and draw the 6 ml of blood, sometime you do not get the full amount of plasma out of the tube, it is always better to have a little more than not enough.

Erica Heath
09-19-2010 12:01 AM

You need to state the amount of blood to be drawn from the arm of the subject.
As the person reading the form, I want to know how much will be drawn.
Erica