SPECTRA OPTIA
Report
- Report Number
- 1722028-2024-00056
- Event Type
- Injury
- Date Received
- February 20, 2024
- Date of Event
- October 22, 2023
- Report Date
- February 20, 2024
- Manufacturer
- TERUMO BCT
- Product Code
- LKN
- PMA / PMN Number
- K183081
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN H.6 AND H.10. INVESTIGATION: IT IS A RETROSPECTIVE OBSERVATIONAL STUDY OF PEDIATRIC PATIENTS SUFFERING FROM ALF CONDUCTED OVER A PERIOD OF 3 YEARS (2018 TO DECEMBER 2021) IN THE DEPARTMENT OF TRANSFUSION MEDICINE, DEPARTMENT OF PEDIATRIC HEPATOLOGY, AND DEPARTMENT OF HEPATO-BILIARY-PANCREATIC SURGERY AT A TERTIARY CARE HOSPITAL IN NORTH INDIA. ALL PEDIATRIC PATIENTS (AGED 0¿18YEARS) WITH ALF WHO UNDERWENT TPE WERE INCLUDED IN THE STUDY AFTER OBTAINING WRITTEN AND INFORMED CONSENT FROM THEIR PARENT/ GUARDIAN. THE AIM, CONCEPT AND DESIGN OF THE STUDY WAS EXPLAINED AT LENGTH TO THE INSTITUTIONAL REVIEW BOARD (IRB). THE CHILDREN DIAGNOSED WITH ALF WERE INITIALLY MANAGED WITH SUPPORTIVE CARE, INCLUDING COMPONENT THERAPY, VITAMIN K SUPPLEMENTATION, FLUID, AND ELECTROLYTE MANAGEMENT AND PROPHYLACTIC ANTIBIOTICS± ANTIFUNGALS. SIMULTANEOUSLY, EVALUATIONS WERE ALSO DONE FOR LIVER TRANSPLANTATION. THE PRIMARY INDICATION OF TPE WAS ALF WITH HEPATIC ENCEPHALOPATHY, WORSENING LIVER PARAMETERS IN SPITE OF MEDICAL MANAGEMENT, AND AS A BRIDGE TO LIVER TRANSPLANT. ALL TPE WERE PERFORMED USING SPECTRA OPTIA APHERESIS SYSTEM 1 P0 4552 (TERUMO BCT INC, LAKEWOOD, COLORADO, USA) WHICH COMES WITH A BUILT-IN SOFTWARE VERSION 11. THERAPEUTIC PLASMA EXCHANGE WAS PERFORMED DAILY OR ALTERNATIVELY UNTIL THE PATIENT RECOVERED, SUCCUMBED, OR WAS STABLE ENOUGH TO UNDERGO A TRANSPLANT. THE EXCHANGE VOLUME FOR EACH PATIENT PER PROCEDURE WAS KEPT 1.5 TIMES THE PLASMA VOLUME (PV) WITH 100% REPLACEMENT. THE REPLACEMENT WAS DONE USING 5% HUMAN ALBUMIN AND FRESH FROZEN PLASMA (FFP) IN A 50:50 RATIO AS PER THE DEPARTMENTAL PROTOCOL. THE TPE WAS PERFORMED AFTER SECURING THE FEMORAL OR INTERNAL JUGULAR VEIN OF THE PATIENTS USING A DOUBLE/TRIPLE LUMEN 7¿9 FR HD CATHETER. CUSTOMIZED PRIMING OF THE APHERESIS MACHINE WAS DONE USING ABO- RH AND AHG CROSSMATCH COMPATIBLE PACKED RED CELL TO FULFILL THE REQUIREMENT OF THE EXTRACORPOREAL VOLUME OF THE MACHINE¿S CIRCUIT TO REDUCE THE LIKELIHOOD OF ANY POSSIBLE HYPOTENSIVE EPISODES IN THE PATIENTS DURING THE PROCEDURE. THE VITALS OF THE PATIENTS, INCLUDING OXYGEN SATURATION, WERE MONITORED THROUGHOUT THE PROCEDURE (S). WE USED ACID CITRATE DEXTROSE SOLUTION A (ACD) AS AN ANTICOAGULANT TO PREVENT CLOTTING IN THE EXTRACORPOREAL CIRCUIT. THE ACD INFUSION RATE WAS MAINTAINED BETWEEN 1.5 AND 1.8 ML/MINUTE AND THE ACD: INLET RATIO WAS KEPT WITHIN THE RANGE OF 1:12¿1:14 DEPENDING ON THE PLATELET COUNTS OF THE PATIENT. MAINTAINING AN ADEQUATE AMOUNT OF ACD IS IMPORTANT TO PREVENT THE FORMATION OF PLATELET CLUMPS IN THE EXTRACORPOREAL CIRCUIT OF THE EQUIPMENT. DURING THE PROCEDURE(S), CONTINUOUS I.V. INFUSION OF DILUTED 10% CALCIUM GLUCONATE WAS THEREFORE, ADMINISTERED TO PREVENT THE SAME. THE SPEED OF THE INLET PUMP WAS MAINTAINED AT AROUND 25¿40 ML/MIN DEPENDING ON THE PATIENT¿S PARAMETERS. THE RINSE BACK AT THE END OF THE PROCEDURE WAS ONLY PERFORMED IN PATIENTS WITH LOW HEMOGLOBIN VALUES AND AFTER DISCUSSING WITH THE TREATING PHYSICIAN IN ORDER TO PREVENT VOLUME OVERLOAD. BIOCHEMICAL PARAMETERS SERUM BILIRUBIN, ALT, AST SERUM AMMONIA SERUM UREA AND SERUM CREATININE WERE RECORDED BEFORE AND AFTER TPE SESSIONS. ABO TITERS, AND OTHER PARAMETERS LIKE SERUM CERULOPLASMIN WERE ALSO RECORDED WHEREVER INDICATED. A TOTAL OF 1710 PATIENTS WERE ADMITTED IN THE PEDIATRIC ICU (PICU) DURING THE STUDY PERIOD OUT OF WHICH 55 HAD ACUTE LIVER FAILURE. THE FINAL STUDY GROUP COMPRISED 14 PATIENTS IN WHICH TPE WAS PERFORMED (FIG. 1). A TOTAL OF 28 TPE WERE PERFORMED IN THESE 14 PEDIATRIC PATIENTS (08 MALES,06 FEMALES, MEAN AGE 8.42 +/- 4.05 YEARS) OVER A PERIOD OF 3 YEARS. AN AGE-WISE DISTRIBUTION OF THE STUDY POPULATION AT THE TIME OF PRESENTATION IS DEPICTED IN FIG. 2. A MEAN OF 2 + /- 1.17 TPE SESSIONS WERE PERFORMED FOR EACH PATIENT. AMONGST THOSE WHO HAD UNDERGONE THE LIVER TRANSPLANT (N = 05), MEAN OF 2 ± 1.41 TPES WERE PERFORMED AS COMPARED TO ABOUT 2 ± 1.11 TPES PERFORMED IN THOSE WITH NATIVE LIVER ONLY (N = 09) WITH A P-VALUE OF 0.42. THE UNDERLYING ETIOLOGY-WISE DISTRIBUTION OF THE PATIENTS OF ALF ALONG WITH THEIR TRANSPLANT STATUS AND AVERAGE NUMBER OF TPES PERFORMED IN EACH CATEGORY IS SHOWN IN TABLE 1. THERE WERE FIVE PATIENTS ADMITTED WITH CRYPTOGENIC HEPATIC FAILURE WITH NO PRIOR HISTORY OF LIVER DISEASE THERAPEUTIC PLASMA EXCHANGES WERE PERFORMED IN THESE PATIENTS WHICH HELPED IN STABILIZING THEM, AND TWO OF THEM UNDERWENT A TRANSPLANT, TWO SURVIVED WITH NATIVE LIVER, AND ONE PATIENT EXPIRED. IN THE INFECTIOUS CATEGORY, THERE WAS A SINGLE CASE OF HEPATITIS A ASSOCIATED ALF AND DENGUE- ASSOCIATED ALF. TWO PATIENTS WERE ADMITTED WITH NON-SPECIFIC COMPLAINTS OF FATIGUE, ABDOMINAL DISCOMFORT, AND JAUNDICE. ON EXAMINATION, HEPATOMEGALY WAS OBSERVED. THEY WERE SUSPECTED TO BE SUFFERING FROM AUTOIMMUNE HEPATITIS WHICH WAS CONFIRMED BY RAISED IMMUNOGLOBULIN LEVELS AND THE PRESENCE OF AUTOANTIBODIES. THE TPE WAS THEREFORE PERFORMED TO REDUCE THE LEVELS OF THE SAME. WE ALSO HAD A SINGLE CASE OF DRUG-INDUCED HEPATITIS WHICH WAS MANAGED CONSERVATIVELY WITH THE HELP OF TPE. OUR STUDY ALSO INCLUDED FOUR PATIENTS OF WILSON DISEASE IN WHOM A MEAN REDUCTION IN 24-HOUR URINARY COPPER LEVELS WAS OBSERVED FROM 1593.55 MCG/DL (PRIOR TO FIRST TPE) TO 954 MCG/DL (AFTER 2¿3 TPE SESSIONS) WITH A P-VALUE OF 0.1679. AMONGST THESE FOUR PATIENTS, THERE WAS ONE CASE PLANNED FOR A MAJOR ABO INCOMPATIBLE LIVER TRANSPLANT (RECIPIENT GROUP O POSITIVE AND DONOR GROUP B POSITIVE). THE TARGETED TITER FOR TRANSPLANT WAS KEPT AT 1:4. A DECLINE IN TITER VALUES OF ANTI-B FROM 1:16¿1:4 WAS ALSO SEEN FOLLOWING TPE, AND THE PATIENT WAS THEN TAKEN UP FOR THE TRANSPLANT. IN OUR STUDY, A TOTAL OF 5 OUT OF 14 PATIENTS UNDERWENT A LIVER TRANSPLANT AND AMONGST THE 9 WHO DID NOT UNDERGO A TRANSPLANT, 4 PATIENTS EXPIRED DUE TO SEPTIC SHOCK SYNDROME WITH SIMULTANEOUS DEVELOPMENT OF ACUTE KIDNEY INJURY (AKI) FOLLOWED BY MULTIPLE ORGAN DYSFUNCTION; THE REMAINING 5 WERE DISCHARGED IN A STABLE CONDITION FOLLOWING TPE SESSIONS. THE DISEASE-FREE SURVIVAL WAS 71.42% (10/14) AND THE TRANSPLANT-FREE SURVIVAL WAS 35.71% (5/14). NO SERIOUS ADVERSE EFFECT OF TPE WAS OBSERVED IN THE PATIENTS DURING OR AFTER THE COMPLETION OF TPE. WITH A P-VALUE OF < 0.05, A SIGNIFICANT CORRELATION WAS OBTAINED FOR SERUM BILIRUBIN, SERUM AMMONIA, AND INR. (TABLE 2). THE MEAN VALUES OF SERUM BILIRUBIN AND SERUM AMMONIA WAS ALSO CALCULATED IN THE NON-TRANSPLANTED GROUP AS AN OVERALL ENTITY AS WELL AS BASED ON THE OUTCOME (I.E., PATIENT ALIVE OR EXPIRED) (TABLE 3). THE P-VALUE OF SERUM AMMONIA WAS FOUND TO BE STATISTICALLY SIGNIFICANT. THE DETAILS OF TIME TO INITIATE TPE AND ITS EFFECT ON PATIENT SURVIVAL ARE GIVEN IN TABLE 4. AS PER THE DEPARTMENTAL POLICY, WE PERFORMED 1.5 PV EXCHANGE WITH 100% REPLACEMENT USING ALBUMIN AND FFP WHICH HELP TO MAINTAIN THE ONCOTIC PRESSURE AND REPLACE THE CLOTTING FACTORS RESPECTIVELY. THE TPE SESSIONS WERE DONE DAILY OR ON ALTERNATE DAYS. AS MENTIONED BY ALEXANDER ET AL., IN THEIR PAPER, IN THE PEDIATRIC POPULATION, A HIGH-VOLUME PLASMA EXCHANGE (HVPE) IS DEFINED AS AN EXCHANGE OF > 1.5¿2.0 PV [2]. IT IS, HOWEVER, NOT PRACTICED COMMONLY AS THE RISK-BENEFIT RATIO DOES NOT FAVOR THE PEDIATRIC POPULATION MUCH. THE HVPE COMES WITH AN INCREASED RISK OF OCCURRENCE OF THE ASSOCIATED COMPLICATIONS PERTAINING TO THE PROLONGED DURATION OF THE PROCEDURE AND THE ANTICOAGULANT (MOSTLY ANTICOAGULANT CITRATE DEXTROSE ACD), USED. THE COMPLICATIONS INCLUDE HYPOTENSION, HYPOCALCEMIA, AND CITRATE TOXICITY, HYPOMAGNESEMIA WHICH OFTEN LEADS TO METABOLIC ALKALOSIS. THE HIGH LEVELS OF CITRATE IN THE ANTICOAGULANT AS WELL AS IN THE FFP, MAKE IT MORE DIFFICULT TO METABOLIZE, ESPECIALLY WHEN THE LIVER FUNCTIONS ARE ALREADY COMPROMISED. THE HVPE ALSO COMES WITH OTHER DISADVANTAGES SUCH AS HIGHER COSTS, AND A GREATER VOLUME OF FFP BEING USED LEADING TO AN INCREASED BURDEN ON THE BLOOD BANK. SOME OTHER COMPLICATIONS MAY ALSO OCCUR SUCH AS CATHETER-RELATED (HEMATOMA, BACTEREMIA, SEPSIS), AND ALLERGIC REACTIONS AGAINST THE REPLACEMENT FLUID USED. SOME LESS COMMONLY ENCOUNTERED COMPLICATIONS INCLUDE BLOOD LEAKAGE, CLOTTING OF THE CIRCUIT, ETC. HOWEVER, IN OUR STUDY, WE DIDN¿T ENCOUNTER ANY SERIOUS ADVERSE EVENTS. CONTINUOUS CALCIUM INFUSION WAS DONE ALL THROUGHOUT THE PROCEDURE TO MANAGE THE CITRATE TOXICITY AND CORRECT ONGOING HYPOCALCEMIA, IF ANY. THE VITALS WERE ALSO MONITORED CONTINUOUSLY TO RECOGNIZE HYPOTENSIVE EPISODES AT THE EARLIEST. A REQUEST FOR LOT NUMBERS IS NOT FEASIBLE BECAUSE THERE ARE MANY MONTHS BETWEEN COLLECTION OF DATA, TO PEER REVIEW, TO FINAL PUBLICATION. THEREFORE, A DHR SEARCH COULD NOT BE CONDUCTED FOR THIS SPECIFIC INCIDENT. ALL LOTS MUST MEET ACCEPTANCE CRITERIA FOR RELEASE. ACCORDING TO THERAPEUTIC APHERESIS: A PHYSICIAN'S HANDBOOK, ADVERSE EVENTS OCCUR DURING THERAPEUTIC PROCEDURES WITH A FREQUENCY OF 4.8%. SOME OF THE MOST COMMON REACTIONS INCLUDE FEVER, URTICARIA, HYPOCALCEMIC SYMPTOMS, PRURITUS, DYSPNEA, TACHYCARDIA, AND MILD HYPOTENSION. ROOT CAUSE: A ROOT CAUSE ASSESSMENT WAS PERFORMED FOR THE REPORTED HYPOCALCEMIA. THE AUTHORS STATED THAT ¿HYPOCALCEMIA SYMPTOMS WERE RESOLVED IN ALL CASES THROUGH ORAL CALCIUM SUPPLEMENTATION.¿ THESE REACTIONS OCCUR DUE TO DECREASED IONIZED CALCIUM IN CIRCULATION AS A RESULT OF EXOGENOUS CITRATE ADMINISTERED DURING THE APHERESIS PROCEDURE AND ARE INFLUENCED BY PATIENT PHYSIOLOGY OR UNDERLYING DISEASE STATE, THE RATE OF AC INFUSION, AND/OR THE LENGTH OF THE PROCEDURE. THESE SYMPTOMS MAY BE TREATED WITH ORAL OR INTRAVENOUS CALCIUM SUPPLEMENTS OR BY ADJUSTING THE AC INFUSION RATE. A ROOT CAUSE ASSESSMENT WAS PERFORMED FOR THE HYPOTENSION. BASED ON THE AVAILABLE INFORMATION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. VASOVAGAL ARE COMMON SIDE EFFECTS OF THERAPEUTIC APHERESIS PROCEDURES. THEY ARE TYPICALLY CAUSED BY THE PATIENT'S DISEASE STATE, THE RATE OF AC INFUSION, THE LENGTH OF THE PROCEDURE, THE PATIENT'S SENSITIVITY TO THE PROCEDURE AND/OR THE HEMODYNAMIC STRESS OF THE PROCEDURE.
LOT NUMBER, MANUFACTURE AND EXPIRY DATE ARE NOT AVAILABLE AT THIS TIME. INVESTIGATION: S MENTIONED BY ALEXANDER ET AL., IN THEIR PAPER, IN THE PEDIATRIC POPULATION, A HIGH-VOLUME PLASMA EXCHANGE (HVPE) IS DEFINED AS AN EXCHANGE OF 1.5 2.0 PV [2]. IT IS, HOWEVER, NOT PRACTICED COMMONLY AS THE RISK-BENEFIT RATIO DOES NOT FAVOR THE PEDIATRIC POPULATION MUCH. THE HVPE COMES WITH AN INCREASED RISK OF OCCURRENCE OF THE ASSOCIATED COMPLICATIONS PERTAINING TO THE PROLONGED DURATION OF THE PROCEDURE AND THE ANTICOAGULANT (MOSTLY ANTICOAGULANT CITRATE DEXTROSE ACD), USED. THE COMPLICATIONS INCLUDE HYPOTENSION, HYPOCALCEMIA, AND CITRATE TOXICITY, HYPOMAGNESEMIA WHICH OFTEN LEADS TO METABOLIC ALKALOSIS. THE HIGH LEVELS OF CITRATE IN THE ANTICOAGULANT AS WELL AS IN THE FFP, MAKE IT MORE DIFFICULT TO METABOLIZE, ESPECIALLY WHEN THE LIVER FUNCTIONS ARE ALREADY COMPROMISED. SOME OTHER COMPLICATIONS MAY ALSO OCCUR SUCH AS CATHETER-RELATED (HEMATOMA, BACTEREMIA, SEPSIS), AND ALLERGIC REACTIONS AGAINST THE REPLACEMENT FLUID USED. SOME LESS COMMONLY ENCOUNTERED COMPLICATIONS INCLUDE BLOOD LEAKAGE, CLOTTING OF THE CIRCUIT, ETC. HOWEVER, IN OUR STUDY, WE DIDN'T ENCOUNTER ANY SERIOUS ADVERSE EVENTS. CONTINUOUS CALCIUM INFUSION WAS DONE ALL THROUGHOUT THE PROCEDURE TO MANAGE THE CITRATE TOXICITY AND CORRECT ONGOING HYPOCALCEMIA, IF ANY. THE VITALS WERE ALSO MONITORED CONTINUOUSLY TO RECOGNIZE HYPOTENSIVE EPISODES AT THE EARLIEST. INVESTIGATION IS IN PROCESS, A FOLLOW-UP REPORT WILL BE PROVIDED.
PER JOURNAL ARTICLE "EFFICACY OF THERAPEUTIC PLASMA EXCHANGE IN PEDIATRIC CASES OF ACUTE LIVER FAILURE AS AN EXTRACORPOREAL LIVER SUPPORT SYSTEM". TRANSFUSION AND APHERESIS SCIENCE 62 (2023): #PAGES#" BY CHOWDHRY, M., SHARMA, A., AGRAWAL, S., VOHRA, R., KUMAR, K., GOYAL, N., KUMAR V, A., JERATH, N., MALHOTRA, S., SIBAL, A., MISHRA, M.. BACKGROUND: ACUTE LIVER FAILURE IN THE PEDIATRIC POPULATION IS OFTEN ACCOMPANIED BY DERANGED METABOLISM, SEVERE ENCEPHALOPATHY AND COAGULOPATHY. A LIVER TRANSPLANT IS THE MOST VIABLE OPTION FOR THE MANAGEMENT OF SUCH PATIENTS. THERAPEUTIC PLASMA EXCHANGE (TPE) IS HELPFUL IN IMPROVING THE LIVER BIOCHEMISTRY PROFILE, THEREBY, INCREASING THEIR LIKELIHOOD OF UNDERGOING A LIVER TRANSPLANT METHOD: THE STUDY WAS CONDUCTED OVER A PERIOD OF 3 YEARS (JANUARY 2018 TO DECEMBER 2021). INDICATIONS MAINLY CONSISTED OF ALF WITH HEPATIC ENCEPHALOPATHY, WORSENING LIVER PARAMETERS IN SPITE OF MEDICAL MANAGEMENT, AND CANDIDACY FOR UNDERGOING A LIVER TRANSPLANT. PLASMA EXCHANGE WAS PERFORMED DAILY OR ALTERNATIVELY UNTIL THE PATIENT RECOVERED, SUCCUMBED, OR WAS STABLE ENOUGH TO UNDERGO A TRANSPLANT. BIOCHEMICAL PARAMETERS SERUM BILIRUBIN, ALT, AST SERUM AMMONIA SERUM UREA, SERUM CREATININE WERE RECORDED BEFORE AND AFTER TPE SESSIONS. RESULTS: THE STUDY GROUP COMPRISED 14 PATIENTS OF WHICH A TOTAL OF 28 TPE WAS PERFORMED. THERE WERE A TOTAL OF 5 CASES OF CRYPTOGENIC ALF, 4 OF WILSON DISEASE, 2 CASES EACH OF INFECTION-RELATED ALF AND AUTOIMMUNE HEPATITIS, AND A SINGLE CASE OF DRUG-INDUCED HEPATITIS. A TOTAL OF 5 OUT OF 14 PATIENTS UNDERWENT A LIVER TRANSPLANT AND AMONGST THE 9 WHO DID NOT UNDERGO A TRANSPLANT, 4 PATIENTS EXPIRED DUE TO SEPTIC SHOCK SYNDROME; THE REMAINING 5 WERE DISCHARGED IN A STABLE CONDITION FOLLOWING TPE SESSIONS. THE DISEASE-FREE SURVIVAL WAS 78.9% AND THE TRANSPLANT-FREE SURVIVAL WAS 35.71%. CONCLUSION: TPE PLAYS A CRUCIAL ROLE IN IMPROVING THE BIOCHEMISTRY PROFILE OF THE LIVER IN CHILDREN WITH LIVER FAILURE. SPECIFIC DETAILS, SUCH AS PATIENT INFORMATION AND OUTCOME, WERE NOT INCLUDED IN THE ARTICLE FOR THESE EVENTS, THEREFORE THIS REPORT IS BEING PROVIDED AS A SUMMARY OF THE EVENTS. IT IS UNKNOWN THAT THIS TIME IF MEDICAL INTERVENTION WAS REQUIRED FOR THESE EVENTS. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
PER JOURNAL ARTICLE "EFFICACY OF THERAPEUTIC PLASMA EXCHANGE IN PEDIATRIC CASES OF ACUTE LIVER FAILURE AS AN EXTRACORPOREAL LIVER SUPPORT SYSTEM". TRANSFUSION AND APHERESIS SCIENCE 62 (2023): #PAGES#" BY CHOWDHRY, M., SHARMA, A., AGRAWAL, S., VOHRA, R., KUMAR, K., GOYAL, N., KUMAR V, A., JERATH, N., MALHOTRA, S., SIBAL, A., MISHRA, M.. BACKGROUND: ACUTE LIVER FAILURE IN THE PEDIATRIC POPULATION IS OFTEN ACCOMPANIED BY DERANGED METABOLISM, SEVERE ENCEPHALOPATHY AND COAGULOPATHY. A LIVER TRANSPLANT IS THE MOST VIABLE OPTION FOR THE MANAGEMENT OF SUCH PATIENTS. THERAPEUTIC PLASMA EXCHANGE (TPE) IS HELPFUL IN IMPROVING THE LIVER BIOCHEMISTRY PROFILE, THEREBY, INCREASING THEIR LIKELIHOOD OF UNDERGOING A LIVER TRANSPLANT METHOD: THE STUDY WAS CONDUCTED OVER A PERIOD OF 3 YEARS (JANUARY 2018 TO DECEMBER 2021). INDICATIONS MAINLY CONSISTED OF ALF WITH HEPATIC ENCEPHALOPATHY, WORSENING LIVER PARAMETERS IN SPITE OF MEDICAL MANAGEMENT, AND CANDIDACY FOR UNDERGOING A LIVER TRANSPLANT. PLASMA EXCHANGE WAS PERFORMED DAILY OR ALTERNATIVELY UNTIL THE PATIENT RECOVERED, SUCCUMBED, OR WAS STABLE ENOUGH TO UNDERGO A TRANSPLANT. BIOCHEMICAL PARAMETERS SERUM BILIRUBIN, ALT, AST SERUM AMMONIA SERUM UREA, SERUM CREATININE WERE RECORDED BEFORE AND AFTER TPE SESSIONS. RESULTS: THE STUDY GROUP COMPRISED 14 PATIENTS OF WHICH A TOTAL OF 28 TPE WAS PERFORMED. THERE WERE A TOTAL OF 5 CASES OF CRYPTOGENIC ALF, 4 OF WILSON DISEASE, 2 CASES EACH OF INFECTION-RELATED ALF AND AUTOIMMUNE HEPATITIS, AND A SINGLE CASE OF DRUG-INDUCED HEPATITIS. A TOTAL OF 5 OUT OF 14 PATIENTS UNDERWENT A LIVER TRANSPLANT AND AMONGST THE 9 WHO DID NOT UNDERGO A TRANSPLANT, 4 PATIENTS EXPIRED DUE TO SEPTIC SHOCK SYNDROME; THE REMAINING 5 WERE DISCHARGED IN A STABLE CONDITION FOLLOWING TPE SESSIONS. THE DISEASE-FREE SURVIVAL WAS 78.9% AND THE TRANSPLANT-FREE SURVIVAL WAS 35.71%. CONCLUSION: TPE PLAYS A CRUCIAL ROLE IN IMPROVING THE BIOCHEMISTRY PROFILE OF THE LIVER IN CHILDREN WITH LIVER FAILURE. PATIENT INFORMATION AND OUTCOME ARE UNKNOWN AT THIS TIME. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 464835 | SPECTRA OPTIA | SPECTRA OPTIA EXCHANGE SET | LKN | TERUMO BCT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |