Preparing And Priming The Hemofiltration (Chemofiltration) Circuit; Assemble Circuit - Delcath Systems CHEMOSTAT Mode D'emploi

• 4 units Fresh Frozen Plasma
• 6 –10 units platelets (depending on institutional guidelines)
• 1 0 units cryoprecipitate
Hydration
• P lace a peripheral large gauge intravenous catheter and begin hydration the
night prior to the procedure at 100-150 mL/hr to ensure the patient is fully
volume expanded.
• A Foley catheter is recommended to closely monitor fluid balance during
hydration.
Antibiotics
• P atients with a history of hepatobiliary surgery or ablative procedures must
receive antibiotic prophylaxis peri-operatively.
Allopurinol
• A s a prophylaxis for possible tumor lysis syndrome, patients with more than 25%
replacement of normal liver parenchyma with tumor are to be given allopurinol
300 mg/day orally beginning two (2) to three (3) days prior to percutaneous
hepatic perfusion (PHP) with the CHEMOSAT System and continuing two (2) to
three (3) days following procedure.
Proton Pump Inhibitors
• T o prevent gastritis which may occur as a result of regional melphalan absorption
during the procedure, administer prophylactic proton pump inhibitors (for
example: omeprazole, one 20 mg delayed release capsule by mouth no later than
8 PM the night before and at 7:30 AM the morning of the procedure followed by
pantoprazole 40 mg intravenous every 8 hours during hospitalization).
Anticoagulation
• T he patient will be systemically anticoagulated with heparin during the
procedure. Proper anticoagulation is required to assure free extracorporeal flow
and filtration. Activated clotting time must be closely monitored to ensure
adequate anticoagulation.
- Obtain the baseline activated clotting time value.
- T he patient must be heparinized only AFTER placement of the 18F (femoral
vein), 10F (jugular vein), and 5F (femoral artery) sheaths. Ultrasound
guidance and single anterior wall puncture technique must be used in order
to avoid bleeding complications.
- The patient must be fully heparinized prior to the insertion of the Isofuse
Catheter into the inferior vena cava. Begin with an initial intravenous bolus
of heparin at 300 units/kg, dose adjusted to achieve activated clotting time.
- A minimum activated clotting time of 400 seconds is necessary prior to
balloon inflation and initiation of veno-venous bypass.
- The activated clotting time must be maintained above 400 seconds by
repeat heparin bolus administration as necessary.
- Initially activated clotting time should be determined as frequently as
necessary (approximately every 5 minutes) until adequate anti-coagulation
is established (activated clotting time > 400 seconds). Activated clotting
time should then be maintained at > 400 seconds throughout the
procedure, by checking it every 15 – 30 minutes depending on the patient's
response and by administering intravenous heparin as needed.
Anesthetic Management
• T reatment must be administered with patients being monitored and under
general anesthesia. Emergency resuscitation equipment must be available during
the procedure.
Blood Pressure Control
• P rocedure related decrease of blood pressure occurs when the balloons occlude
blood return from the inferior vena cava (decreased cardiac inflow) and when the
filters are brought into the extra-corporeal bypass circuit. The reasons for filter-
related hypotension are multifactorial, but hypersensitivity to non-physiological
surfaces (inflammatory response) and removal of catecholamines by the filters
play a role.
Blood pressure must be constantly monitored throughout the procedure and
maintained at levels required for adequate perfusion of critical end-organs.
o Hemodynamic Management:
- Administration of methylprednisolone 125 mg, 30 – 60 minutes pre-
percutaneous hepatic perfusion.
- Intra-procedural administration of fluids and infusion of phenylephrine
(or other vasopressor agent) to mitigate and correct procedure-related
decrease in blood pressure.
- V asopressor Agents: Prior to inflation of either balloon (occlusion of
inferior vena cava), phenylephrine is to be administered to assess patient
responsiveness to this agent. After inflation of the balloons, patients must
be assessed for two (2) to five (5) minutes for changes in blood pressure,
prior to bringing the two (2) filter cartridges on line. Significant decreases
in blood pressure will occur within two (2) to five (5) minutes. Thus, the
vasopressor agents must be continued to maintain mean blood pressures
above 65 mmHg. Vasopressor agents are typically not required after the
conclusion of the procedure.
Prior to set up, provide pre-notification to the hospital pharmacy to be ready to
prepare chemotherapeutic agent (Melphalan Hydrochloride for Injection). An
actual request for drug preparation and delivery should be timed so that the
start of the infusion of the melphalan is within thirty minutes of preparation.
Drug administration should be completed within 60 minutes of the start of
preparation.
System Components
Confirm that all components of the CHEMOSAT System are available for assembly.
Note: Certain components are not supplied by Delcath. Verify that the Medtronic
pump is functioning properly (see pump operating manual for instructions on proper
functionality).
PREPARING AND PRIMING THE
HEMOFILTRATION (CHEMOFILTRATION)
CIRCUIT
CAUTION: Adherence to strict sterile procedures is mandatory at
all times.

1. Assemble Circuit

See Figure 1 (Assembled System) for reference to a completely assembled circuit.
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