Drug Administration And Extracorporeal Filtration; Ending Extracorporeal Circulation; Catheter Removal; Normalization Of Coagulation Status For Sheath Removal - Delcath Systems CHEMOSTAT Mode D'emploi

WARNING
Vasopressor Agents: Significant Decreases In Blood Pressure Will Occur.
Thus, The Vasoactive Agents Must Be Continued To Maintain Mean
Blood Pressures Above 65 mmHg. Vasopressor Agents Are Typically Not
Required After The Conclusion Of The Procedure.

19. Drug Administration and Extracorporeal Filtration

(a) When the Hemofiltration Circuit is running satisfactorily and hemodynamic
stability is achieved, flush the hepatic arterial infusion line with normal saline
to avoid directly mixing heparin with chemotherapeutic agent (melphalan
hydrochloride). Connect Chemofuse catheter with drug infusion line.
b) Following normalization of blood pressure, perform an arteriogram to assess patency
of the hepatic artery. In circumstances where hepatic arterial spasm is noted,
nitroglycerine must be administered intra-arterially to alleviate the spasm.
WARNING
Assess Arterial Patency Approximately Every Four (4) to Five (5) Minutes Via Contrast
Administration During Drug Infusion.
Administer Nitroglycerin if Arterial Spasm is Noted. If Spasm Cannot be Relieved,
Terminate the Procedure (see Ending Extracorporeal Circulation below).
(c) V isually inspect the chemotherapeutic agent (melphalan hydrochloride) solution
for particulates. If particulates are observed, DO NOT USE.
(d) Initiate administration of chemotherapeutic agent (melphalan hydrochloride)
through the hepatic arterial catheter over a period of 30 minutes. Injection of
melphalan diluted in to 500 mL of saline is infused over 30 minutes. During the
infusion, the injector is reloaded to fill its syringe; during the reloading time
contrast injection checks for hepatic artery spasm. If spasm is encountered IA
NTG is administered. Infusion of the drug should be stopped if there is persistent
intractable spasm.
WARNING
Immediately Stop the Procedure if Perfusion of Drug is Detected Outside of the
Isolated Region and Cannot be Corrected. Once the Infusion of chemotherapeutic
agent (melphalan hydrochloride) has Started, Do NOT Deflate Balloons Unless
Administration of Drug has been Stopped And a Full Washout Cycle (30 Minutes)
had been Completed.
(e) Continue extracorporeal filtration for 30 minutes (washout period), after the
entire prescribed dose of drug has been delivered.

20. Ending Extracorporeal Circulation

(a) At the end of the 30-minute wash-out period, deflate the caudal balloon fully.
(b) Then deflate the cephalad balloon fully.
(c) D iscontinue filtration by reducing the pump RPM to 1000, closing clamps 3 and 9,
and then stop flow by turning off the pump.
(d) A portion of blood in the circuit may be returned to the patient by adding sterile
saline into the circuit to flush the blood back into the patient. Do not open the
bypass line clamps.

21. Catheter Removal

(a) R emove the Chemo Delivery catheter. The 5F arterial sheath should only be
removed when coagulation status has been normalized
(b) R emove Isofuse catheter carefully and replace with 18F obturator. Ensure the
obturator is placed completely into the sheath so the obturator hub bottoms
out onto the sheath hub. The 18F venous sheath should only be removed when
coagulation status has been normalized.
(c) Close the stopcock or red clamp on the 10F venous return sheath sideport and
disconnect the venous return line from the sheath. Do not remove the 10F venous
return sheath until coagulation status has been normalized.
(d) Dispose of all components appropriately in accordance with hospital, local, state,
and federal biohazard guidelines.

22. Normalization of Coagulation Status for Sheath Removal

(a) Administer protamine sulfate by slow intravenous infusion in a dose appropriate
to the amount of heparin given and the activated clotting time.
(b) Administer 10 units of cryoprecipitate and/or Fresh Frozen Plasma based
on coagulation profiles to correct remaining abnormalities per institutional
guidelines.
(c) R epeat coagulation profile.
(d) Correct remaining coagulopathy following institutional guidelines. The following
recommendations are provided for consideration:
Coagulation Profile
Prothrombin time greater than 2 seconds of
normal
Partial thromboplastin time greater than 5
seconds of normal
(e) Plasma albumin and globulin levels are replenished when Fresh Frozen Plasma is
given. If replacement is needed, infuse according to institutional guidelines.
(f) Measure blood platelet levels to determine if replacement is needed. Follow
hospital protocols and transfuse accordingly.
(g) Follow institutional guidelines for administration of packed red blood cells for
anemia.
(h) All sheaths may be safely removed if the platelet count is greater than 50,000/
mm and after the patient's coagulation status has normalized. Puncture sites
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should be compressed until adequate hemostasis is achieved.
(i) Dispose of all components appropriately in accordance with hospital, local, state,
and federal biohazard guidelines.
(j) Carefully monitor the patient until complete recovery.
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Action
Adminsiter Fresh Frozen Plasma
Administer protamine