Trial Documentation

PEXIVAS study visit forms

Contact Details and Assessment Schedule

Baseline

Download and Complete Form 1.1: Randomisation Notepad
Download and Complete Form 1.2: Entry

Baseline

Other forms to be completed at this visit

Required Samples to be collected at this visit Required (for patients that have consented to sample collection)
BVAS/WG Yes DNA Pax Tube Yes
CDA  Yes RNA Pax Tube Yes
SF-36 Yes Serum Tube Yes
EQ-5D Yes Plasma Tube Yes
 
Renal Biopsy Yes

Week 2

Download and Complete Form 2.1: Week 2 Follow-up

Other forms to be completed at this visit

Required Samples to be collected at this visit Required (for patients that have consented to sample collection)
BVAS/WG Yes DNA Pax Tube No
CDA  No RNA Pax Tube No
SF-36 No Serum Tube Yes
EQ-5D No Plasma Tube Yes

 

Week 4

Download and Complete Form 3.1: Week 4 Follow-up

Other forms to be completed at this visit

Required Samples to be collected at this visit Required (for patients that have consented to sample collection)
BVAS/WG Yes DNA Pax Tube No
CDA  No RNA Pax Tube No
SF-36 No Serum Tube No
EQ-5D No Plasma Tube No

 

Week 8

Download and Complete Form 4.1: Week 8 Follow-up

Other forms to be completed at this visit

Required Samples to be collected at this visit Required (for patients that have consented to sample collection)
BVAS/WG Yes DNA Pax Tube No
CDA  No RNA Pax Tube No
SF-36 No Serum Tube No
EQ-5D No Plasma Tube No
 

Week 12

Download and Complete Form 5.1: Week 12 Follow-up

Other forms to be completed at this visit

Required Samples to be collected at this visit Required (for patients that have consented to sample collection)
BVAS/WG Yes DNA Pax Tube No
CDA  Yes RNA Pax Tube Yes
SF-36 Yes Serum Tube Yes
EQ-5D Yes Plasma Tube Yes

Week 26

Download and Complete Form 6.1: Week 26 Follow-up

 

Other forms to be completed at this visit

Required Samples to be collected at this visit Required (for patients that have consented to sample collection)
BVAS/WG Yes DNA Pax Tube No
CDA  Yes RNA Pax Tube No
SF-36 Yes Serum Tube No
EQ-5D Yes Plasma Tube No

Week 39

Download and Complete Form 7.1: Week 39 Follow-up

 

Other forms to be completed at this visit

Required Samples to be collected at this visit Required (for patients that have consented to sample collection)
BVAS/WG Yes DNA Pax Tube No
CDA  No RNA Pax Tube No
SF-36 No Serum Tube No
EQ-5D No Plasma Tube No

Week 52

Download and Complete Form 8.1: Week 52 Follow-up

 

Other forms to be completed at this visit

Required Samples to be collected at this visit Required (for patients that have consented to sample collection)
BVAS/WG Yes DNA Pax Tube No
CDA  Yes RNA Pax Tube Yes
SF-36 Yes Serum Tube Yes
EQ-5D Yes Plasma Tube Yes

6 Monthly

Download and Complete Form 9.1: 6 Monthly Follow-up

 

Other forms to be completed at this visit

Required Samples to be collected at this visit Required (for patients that have consented to sample collection)
BVAS/WG Yes DNA Pax Tube No
CDA  Yes RNA Pax Tube No
SF-36 Yes Serum Tube No
EQ-5D Yes Plasma Tube No

PEXIVAS outcome forms

Form 10: Death

Form 11: ESRD

Form 12: Resistant Disease

Form 13: Relapse

Form 14: SAE

Form 15: Infection

Form 16: Plasma Exchange

Form 17: Lung Haemorrhage

Form 18: Remission:  Remission information should be reported on the Follow-Up Form from Week 4 onwards. 

Form 19: BVAS/WG

Form 20: CDA

Form 21: SF-36 - Please contact the PEXIVAS Office

             Header Sheet for Inclusion with Translated SF-36 Forms

Form 22: Deviation from Glucocorticoid Dose

Form 23: EQ-5D

Header Sheet for Inclusion with Translated EQ-5D Forms

To calculate A-a O2 gradient please use the following link:

http://www.mdcalc.com/a-a-o2-gradient

PEXIVAS Protocol

Centres should contact the PEXIVAS Study Office in Cambridge for the full protocol - please email Biljana Brezina at bjovanovska@nhs.net