A Multicenter Randomized Placebo-Controlled Trial of Intravenous Thyroxine for Heart-Eligible Brain Dead Organ Donors
Phase: PHASE3
Conditions: Brain Death, Heart Failure
Sponsor: Washington University School of Medicine

Title 
A Multicenter Randomized Placebo-Controlled Trial of Intravenous Thyroxine for Heart-
Eligible Brain Dead Organ Donors 
 
NCT: 04415658 
 
APPENDIX A: Study Forms 
 
Document Date: 01 December 2020 
 

A Multi-OPO Randomized Control Trial of T4 vs Placebo   Screening Worksheet #1 
*To be filled out on EVERY  Brain-dead donor 
OPO: ________________________ 
Donor UNOS #: ________________ 
Date: ____ / ____ / 20____ (mm/dd/yyyy) 
Inclusion Criteria:  (Must have ALL 4 inclusion criteria) 
1. _____  Declared dead by neurologic criteria 
 
2. _____   Authorization for organ donation and research 
 
3. _____   Donor age 14-55 years inclusive, and weight ≥ 45 kg (100 lbs.) 
 
4. _____   Must be on 1 or more of the following vasopressors and/or inotropes at the start of 
the study: 
 
a. _____  norepinephrine  
b. _____  epinephrine  
c. _____  neosynephrine     
d. _____  dopamine 
e. _____  dobutamine  
f. _____  milrinone 
 
Exclusion Criteria:  (Must NOT have any exclusion criteria) 
1. _____  Brain-death declared >24 hours ago 
2. _____  CAD or MI (by hx, EKG, or previous cardiac cath) that would exclude transplantation 
3. _____  Significant valvular heart disease (by hx or echo) that would exclude transplantation 
4. _____  Previous sternotomy or cardiac surgery 
5. _____  Donor is in a VA hospital 
6. _____  Received IV or po T4/T3 in the last month (including home medication) 
7. _____  Known HIV+ serology 
8. _____  Other reason:_____________________________________________ 
***If the donor has all 4 inclusion criteria and no exclusion criteria, he/she is eligible for the 
study and should be randomized to either T4 or NS, and the infusion should be started as 
soon as possible.*** 
 
 
 
ELIGIBLE  (go to worksheet) 
 
NOT ELIGIBLE – STOP! 
All worksheets are to be submitted to the OPO research coordinator  
Revised 10/22/2020 

Worksheet #2 
Multi-OPO Randomized Control Trial of T4 vs Placebo Data Collection Worksheet 
UNOS number: __________________  
 
 
 
 
 
(revised 11/5/2020) 
OPO: _________________________________________________ 
1. Admission to the hospital: Date: ____ / ____ / 20____; Time: ____:____ (all times in 24:00) 
2. Brain Death:                          Date: ____ /____ / 20____;  Time: ____:____ 
Go to Sharepoint, Multi-OPO T4 RCT randomization sheet to identify the next randomization. 
3. Randomized to:                   T4                                 NS 
***Draw free T4, TSH prior to starting T4 / NS infusion. 
   
4a. Baseline results before starting T4 or saline:   Weight _______ kg 
      4b. Vent settings:  f _____  Vt  _____ cc  FiO2  _____  PEEP _____   PaO2 _____ 
      Labs: (most recent before starting protocol) [enter 999 if data not available] 
c. Highest Troponin I (before starting protocol) _________ ng/ml  
d. ALT _________ 
e. AST _________ 
f. Bilirubin __________ 
g. Creatinine __________ BUN __________ 
h. Amylase _________ 
i. INR _________ 
j. Calcium (total) _________ or  k. Calcium (ionized) _________ 
 
 
5. T4 or NS started:  Date: ____ /____ / 20____;  Time: ____:____ 
(needs to be started within 24 hours of brain-death declaration) 
 
6. T4 rate:  30mcg/hr [ 500 mcg/ 500 cc NS at 30 cc/hr = 30 mcg/hr]  
a. Was T4 started at 30 mcg/hr  Yes ____    No ____ 
b. If No, what was the reason: _______________________________________ 

 
7.  NS rate 30 cc/hr  [should be equal to the normal T4 dose, i.e. 30 cc/hr] The donor may 
be on additional IV fluids as needed, but needs to have a separate IV of NS @ 30 cc/hr to 
match the fluid intake with the T4 protocol. 
a. Was NS started at 30 cc/hr?  Yes ____    No ____ 
b. If No, what was the reason: ___________________________________________ 
 
     ***   Please fill out the Multi-OPO RCT T4 Vasopressor Flow Sheet #3.   *** 
 
***The only allowed doses of T4 are 30 mcg/hr, 20 mcg/hr, 10 mcg/hr.  Decrease the dose by   
10 mcg/hr,  if a lower dose is needed.*** 
8. Was the T4 dose decreased before 12 hours?   Yes ____    No ____ 
If Yes, what was the reason? (check all that apply) 
a. ____Tachycardia (HR increased more than 20 bpm over baseline and is > 120 bpm) 
b. ____Hypertension (Systolic BP increased >30 mmHg and is >180 mmHg) 
c. ____Arrhythmia: ____ a fib/flutter; _____ SVT; _____ V tach; _____ PVCs(>6/min) 
d. ____Other: __________________________________________________ 
 
9. Was the T4 dose stopped before 12 hours?    Yes ____   No ____ 
If Yes, what was the reason? (check all that apply) 
a. ____Tachycardia (HR increased more than 20 bpm over baseline and is > 120 bpm)  
b. ____Hypertension (Systolic BP increased >30 mmHg and is >180 mmHg) 
c. ____Arrhythmia: ____ a fib/flutter; _____ SVT; _____ V tach; _____ PVCs(>6/min) 
d. ____Other: __________________________________________________ 
 
10. Time first echo ordered after T4/NS started:                                                                         
Date: ____ /____ / 20____;  Time: ____:____ 
 
11. Ejection Fraction from first echo: __________% 
 
12. If the donor was on T4 and completed the 12-hour protocol, was the T4 stopped within 
60 minutes after the 12-hour study period?  If the T4 stopped before 12 hours, answer 
N/A and go to #15. 
_____ Yes [skip to #15]     _____ No  [go to #13] _____N/A [skip to #15] 

If the donor was in the NS group, skip to question #14. 
 
13. What was the reason the T4 was continued beyond the study period? 
a. Still on vasopressors   ________ 
b. Still on inotropes   _________ 
c. Physician’s preference ________ 
d. Other  _____________________________________________ 
e. Dose of  T4 __________ mcg/hr 
f. Time T4 stopped: Date: ____ /____ / 20____;  Time: ____:____ 
Go to Question #15. 
  
 
 
14. If the donor was randomized to NS, did the donor receive T4 after enrollment in the 
study (“open-label”)?   
____ Yes   ____ No           
 
If yes, what was the reason? 
a. Still on vasopressors   ________ 
b. Still on inotropes   _________ 
c. Physician’s preference ________ 
d. Other  _____________________________________________ 
e. Dose of open-label T4 __________ mcg/hr 
f. Time open-label T4 started: Date: ____ /____ / 20____;  Time: ____:____ 
g. Time open-label T4 stopped: Date: ____ /____ / 20____;  Time: ____:____ 
 
15. If more than 1 echo was performed, fill in the data below: [enter 999 in EF if not done] 
a. 2nd echo:  EF  _______%   Date: ____ /____ / 20____;  Time: ____:____ 
b. 3rd echo:   EF  _______%   Date: ____ /____ / 20____;  Time: ____:____ 
c. 4th echo:   EF  _______ %  Date: ____ /____ / 20____;  Time: ____:____ 
 
   

Draw free T4 before going to the OR or at end of donor management on all 
donors in the study (T4 and control group) 
 
16. Baseline Serum free T4 _________ ng/dl         TSH _________ mIU/L 
 
17. Serum free T4 level  _________ ng/dl prior to OR. 
 
 
18. Was heart transplanted ? Yes______  No _________ 
 
If heart not transplanted, what was the reason? (check all that apply) 
a. ____Decreased EF, poor function,  
b. ____CAD:  1 vessel ____   2 vessel ____  3 vessel ____ 
c. ____LVH 
d. ____Size 
e. ____Medical history (smoking, diabetes, HTN, etc) 
f. ____Positive serologies 
g. ____Increased risk 
h. ____Match list exhausted 
i. ____Recipient issues 
j. ____Intra-op decline 
k. ____Surgical injury 
l. ____Valvular disease 
m. ____Other __________________________________ 
 
 
 

 
 ADVERSE EVENTS: Please identify any new adverse events that occurred in the donor, 
regardless if they received T4 or NS, after the start of the study: 
19. Did the donor experience any of the following adverse events?  Yes ____ No ____ 
If YES, please check all that occurred: 
a.____ Severe hypertension (BP >200 mm Hg) 
b.____ Tachycardia (HR> 150; including sinus tach, SVT, PSVT) 
c.____ Fever (>102 degree) 
d.____ A fib or a flutter 
e.____ Ventricular ectopy (>6 VPCs/min, bigeminy, trigeminy) 
f.____ V tach (spontaneously resolved) 
g.____ V tach (requiring cardioversion) 
h.____ V fib (requiring defibrillation) 
i.____ cardiac arrest* 
j.____ cardiac death prior to the OR* 
k.____ new skin rash 
l.____ other:  ___________________________________________________ 
19 m. Was the adverse event related to the T4 infusion?   
 
____ YES 
____ NO 
____ UNCERTAIN 
19 n. Please describe the adverse event: _______________________________________ 
_________________________________________________________________________ 
*These events need to be reported to the DSMB. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
20. Name of person filling out worksheet:  ________________________________________ 
Date: ____________________________ 
For the Research Coordinator: After the case is completed, please upload the SRTR data to the 
Excel Spread sheet.

T4 Vasopressor Flow Sheet #3 
UNOS #: _____________________   OPO: _____________    Date Enrolled: _________               [randomized to    T4: ___   or  NS: ___ ]       
 
 
 
 
 
BLOOD PRESSURE 
VASOPRESSOR AND INOTROPE DOSES (ENTER ZERO IF NOT ON THE DRUG) 
 
INTERVAL 
Time 
(Military) 
(HR:min) 
T4 
Dose 
(mcg/
hr) 
Saline 
Dose 
(cc/hr) 
Heart 
Rate 
 Invasive 
 Non-Invasive 
Levophed* 
(mcg/min) 
Epi* 
(mcg/kg/ 
min) 
Neo* 
(mcg/min) 
Dopamine  
(mcg/kg/ 
min) 
Dobutrex* 
(mcg/kg/ 
min) 
Milrinone 
(mcg/kg/ 
min) 
Vaso* 
(U/hr) 
Sys 
Dias 
BASELINE 
Before first 
dose of 
T4/NS 
: 
 
 
 
 
 
 
 
 
 
 
 
 
2 HOURS 
: 
 
 
 
 
 
 
 
 
 
 
 
 
4 HOURS 
: 
 
 
 
 
 
 
 
 
 
 
 
 
6 HOURS 
: 
 
 
 
 
 
 
 
 
 
 
 
 
8 HOURS 
: 
 
 
 
 
 
 
 
 
 
 
 
 
10 HOURS 
: 
 
 
 
 
 
 
 
 
 
 
 
 
12 HOURS 
: 
 
 
 
 
 
 
 
 
 
 
 
 
END OF 
DONOR 
MGMT1 
 
 
 
 
 
 
 
 
 
 
 
 
 
12-hour intake: _____________ ml 
 
Date Vasopressor 
Ended 
___/___/___ 
___/___/___ 
___/___/___ 
___/___/___ 
___/___/___ 
___/___/___   
 
12-hour output:_____________ ml 
 
Time Vasopressor 
Ended 
: 
: 
: 
: 
: 
: 
12-hour NET I/O:_____________ ml 
 
 
 
*Norepinephrine 
*Epinephrine 
*Neosynephrine 
 
*Dobutamine 
 
*Vasopressin 
Date/Time T4 stopped (Use Military Time):  _____/_____/_____  at   _____:_____    
Notes/Comments: _____________________________________________________________________________________________________ 
Name of coordinator filling out worksheet: _______________________________________ 
1 End of Donor Management is defined as when the donor was sent to the OR or was extubated in the ICU if no organs are procured.