Clinical Trial Protocol (May Be Used Off-Protocol)
Clinical Study
Brief Description: Subjects and Groupings: Our study will focus on 306 patients who have
suffered brain death and have been consented for organ donation via regional
organ procurement organization policy.
These patients will then be randomized into four study arms patient arms
based on cause of race, gender, age,
blood type, cause of death, smoking status, presence of hypertension, presence
of hepatitis, and serum creatinine > 1.5 at the time of consent. Number and grouping of subjects is shown in
figure 16. Patient exclusion criteria (for
the clinical trial, not necessarily in practical use) will be: 1) age less than
18 years, 2) patient with previous abdominal surgery to the extent that
placement of DPR catheter would represent an unacceptable risk to organ
retrieval, 3) patients donating after cardiac death, 4) Hemodynamic instability
following brain death to the extent that subjects are expected to need urgent
organ procurement within 8 hours of consent, 5) patients whose geographic
location precludes the expeditious placement of a DPL catheter within 6 hours
of donation consent.
Clinical Protocol:
1.
Identify
potential donor candidate for study (see exclusion criteria)
2.
Obtain
donation consent via usual OPO process
3. Utilize
study website for randomization protocol (4 groups, 2 randomized to control and
2 to DPR)
4. Draw
Time 0 blood specimen (2 red top tubes)
5.
Surgeon
to place DPL catheter using Bard DPL catheter kit (provided)
6.
Technique:
Briefly,
under sterile technique at the bedside, an infra umbilical incision will be
made in the skin in order to directly visualized the abdominal wall fascia. The
fascia will be incised and under direct visualization a catheter will be placed
into the peritoneal cavity and directed towards the pelvis. The skin will be closed around the catheter
and sterile dressing applied.
7.
Initiate
DPR solution Delflex 2.5% (3 liter bag) – instill 1 liter over an hour, let
that liter dwell in patient for an hour, and then allow gravity to empty
patient for an hour (total 3 hour cycle).
Repeat this process though the first 9-12 hours of donor management
(usually 1-2 bags of Delflex 2.5% PD solution).
8. Draw
Time 3 hours blood specimen (2 red top tubes) – 3 hours post initiation of DPR
9. Draw
Time 6 hours blood specimen (2 red top tubes) – 6 hours post initiation of DPR
10. Draw
Time 12 hours blood specimen (2 red top tubes) – 12 hours post initiation of
DPR
11. Draw
Procurement blood specimen (2 red top tubes) – just prior to going to or in OR
for recovery
12.
DPR
catheter may be removed prior to recovery (just remove stitch and pull out)
13. All ten
blood tubes will be labelled with preprinted labels (provided) and mailed to our
site laboratory on dry ice following recovery (or next morning depending on
availability of UPS services (mailers will be provided to study sites)
14. Complete
paperwork in DonorNet as per your usual process
Donor
management will occur by the usual OPO process and all documentation will
follow the usual OPO process. The principle study site (University of
Louisville) and KODA will provide personnel to coordinate the retrieval of
electronic data from DonorNet. Each OPO
will manage their own portion of the grant funds via contract and distribute
physician/personnel payment as they see fit.
Supply charges are built into the grant budget.
