BLOOD TRANSFUSION CLINICAL PRACTICE MANUAL

Product Information - Cryosupernatant Plasma (CSP) Page 1 of 6

Name of Product Cryosupernatant Plasma

Other Name(s) CSP Manufacturer(s) Canadian blood Services (CBS) Date Effective: Jan 2005 Date of Last Review: 2021/06/16

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Administration

Availability

Contraindications

Description of Product

Dose

Indications for Use

Management of Adverse Effects

References & Further Information

Storage

Warnings & Precautions

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This is a controlled document. Any copies appearing in paper form must be checked against the electronic version prior to use. This resource has been created specifically for LHSC/SJHC and may not be applicable for other centres. These documents are the intellectual property of LHSC/SJHC. They are not to be shared or duplicated without permission

BLOOD TRANSFUSION CLINICAL PRACTICE MANUAL

Product Information - Cryosupernatant Plasma (CSP) Page 2 of 6

DESCRIPTION OF PRODUCT

• Cryosupernatant Plasma is prepared from slowly thawed Frozen Plasma (FP) that is centrifuged to separate the plasma from the insoluble cryoprecipitate. The insoluble cryoprecipitate is removed and the remaining “Cryosupernatant plasma” is refrozen.

• Frozen Plasma is prepared by CBS from approx 480 mL of whole blood collected from volunteer donors. The collection bag contains 70 mL of Citrate Phosphate Dextrose (CDP) as an anticoagulant. The whole blood is centrifuged and FP is separated from the red blood cells and buffy coat. FP is frozen within 24 hours of collection.

• Average CSP unit has a volume of 273 mL

• CSP provides a source of plasma that is known to have reduced levels of von Willebrand Factor, including high molecular weight multimers

• All donor samples are tested for ABO group, Rh type and unanticipated antibodies against red cell antigens. ABO group is listed on the component label. Rh type may also be listed on the component label.

• A sample of each donor’s blood must test non-reactive for o Antibodies to Human Immunodeficiency Virus (HIV-1 and HIV-2), Hepatitis C Virus (HCV), Human T-cell Lymphotropic Virus type I and II (HTLV-I/II), Hepatitis B core antigen (HBcore) o Hepatitis B surface antigen (HBsAg) o Presence of viral RNA (HIV-1, HCV) o Presence of viral DNA {Hepatitis B virus (HBV)} o Syphilis

• Donor sample is tested for antibodies to Trypanosoma cruzi (t. cruzi or Chagas Disease) and presence of viral RNA {West Nile Virus (WNV)} only where risk is increased

• CSP may be stored in DEHP (di-ethyl hexyl phthalate) plasticized bags or non- DEHP plasticized bags (depending on the manufacturer)

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This is a controlled document. Any copies appearing in paper form must be checked against the electronic version prior to use. This resource has been created specifically for LHSC/SJHC and may not be applicable for other centres. These documents are the intellectual property of LHSC/SJHC. They are not to be shared or duplicated without permission

BLOOD TRANSFUSION CLINICAL PRACTICE MANUAL

Product Information - Cryosupernatant Plasma (CSP) Page 3 of 6

AVAILABILITY

• CSP is ordered from CBS as required STORAGE

Storage in Transfusion Medicine (TM) prior to reconstitution: • CSP is stored frozen at - 18 °C or colder for a maximum of 12 months. • Once thawed, CSP should not be re-frozen. • Once thawed, CSP can be stored in TM at 1 - 6 °C and must be transfused within 120 hours.

Storage after reconstitution: • Once dispensed from TM, CSP must be transfused within 4 hours of from time of dispense (noted on Chart label) • Do not refrigerate • Do not place in a transport igloo • If CSP unit is not transfused, return unit(s) to TM.

INDICATIONS FOR USE

• In London Hospitals, use of Cryosupernatant Plasma (CSP) is specifically used for Plasma Exchange Treatment (Plasmapheresis) o Patients with thrombotic thrombocytopenia purpura (TTP) or hemolytic uremic syndrome (HUS) undergoing plasma exchange.

• CSP is preferred in TTP/HUS since it has reduced levels of von Willebrand Factor, including high molecular weight multimers

If use is other than Plasma Exchange, refer to Frozen Plasma CONTRAINDICATIONS

• Do not use CSP for conditions which require von Willebrand factor supplementation • CSP should not be used to treat hypovolemia • Patients with known anaphylaxis to plasma should only receive CSP under suitable medical guidance

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This is a controlled document. Any copies appearing in paper form must be checked against the electronic version prior to use. This resource has been created specifically for LHSC/SJHC and may not be applicable for other centres. These documents are the intellectual property of LHSC/SJHC. They are not to be shared or duplicated without permission

BLOOD TRANSFUSION CLINICAL PRACTICE MANUAL

Product Information - Cryosupernatant Plasma (CSP) Page 4 of 6

DOSE

Adult Dose: • For plasma exchange, the number of units to be transfused is according to the plasma exchange protocol

Neonatal/Pediatric Dose: • For plasma exchange, the number of units to be transfused is according to the plasma exchange protocol

ADMINISTRATION

Consent: • Consent for transfusion of blood / blood products is required

Dispensed from TM: • Supplied frozen by CBS; when requested, TM will thaw with gentle agitation in a water bath at 30 – 37 °C and then dispense ready to transfuse. (thawing time is about 30 to 40 minutes)

• TM will dispense a maximum of 10 units at one time. (The remainder of the dose ordered will subsequently be thawed and dispensed in batches of approx.10 units at a time as each batch is thawed.)

Route of Administration: SC NO IM NO IV Infusion YES * Direct NO * By nurse who has completed the IV Direct Administration iLearn module

IV Fluid / Tubing: • Administered with 40/150 Micron Dual Screen filter for plasma exchange • To be infused with 0.9% Sodium Chloride only • Do not mix with any other medications

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This is a controlled document. Any copies appearing in paper form must be checked against the electronic version prior to use. This resource has been created specifically for LHSC/SJHC and may not be applicable for other centres. These documents are the intellectual property of LHSC/SJHC. They are not to be shared or duplicated without permission

BLOOD TRANSFUSION CLINICAL PRACTICE MANUAL

Product Information - Cryosupernatant Plasma (CSP) Page 5 of 6

Infusion Rate: • For plasma exchange, the infusion rate is according to the plasmapheresis protocol • The flow rate for plasma exchange is 50 to 80 mL/minute, starting transfusion slowly is not feasible.

Discard by Time: • Transfusion must be completed within 4 hours from time of dispense from TM. (noted on Chart label)

• After 4 hours, CSP should be discontinued and any remaining CSP discarded in a biohazard waste container Monitoring: • Patient monitoring and vital signs, minimum: within 30 minutes prior to the start of transfusion, after 15 minutes of transfusion, after transfusion completed

Documentation: • Documentation of transfusion: Completed Chart label (provided by TM when CSP issued) Vital signs and fluid volume as per specific clinical area If implemented in specific clinical area, Electronic health record, Cerner Menu, I View, bridge

WARNINGS & PRECAUTIONS

• CSP must be ABO compatible with the patient’s red blood cells (ABO Compatibility Table). Rh does not need to be considered

• A group and screen sample test result from the current course of plasma exchange treatment or current hospital admission is required to issue compatible CSP.

• Unequivocal identification of the recipient (patient) is mandatory (unmistakable identification, using unique patient identifiers of PIN, surname and first name).

• Some clotting actor activity in thawed CSP may be significantly lost during storage for up to 120 hours

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This is a controlled document. Any copies appearing in paper form must be checked against the electronic version prior to use. This resource has been created specifically for LHSC/SJHC and may not be applicable for other centres. These documents are the intellectual property of LHSC/SJHC. They are not to be shared or duplicated without permission

BLOOD TRANSFUSION CLINICAL PRACTICE MANUAL

Product Information - Cryosupernatant Plasma (CSP) Page 6 of 6

• CSP is a human blood component. Manufacturing processes and screening procedures are extensive to reduce the risk of transmission of infectious pathogens, but the potential risk of transmission cannot be totally excluded. (Risk Information)

• Any indication of infectious disease transmission must be reported to TM for further investigation.

• Some CBS blood collection needles are in contact with latex; CSP cannot be guaranteed to be latex free MANAGEMENT OF ADVERSE EFFECTS

If signs or symptoms of an adverse reaction: Stop the transfusion Keep IV patent with rescue IV of 0.9% Sodium Chloride Epinephrine should be readily available Re-assess patient’s vital signs Confirm patient’s PIN, surname and first name with blood product label. Notify the Physician. Refer to TRAC for recommended clinical actions and to report reaction to TM. All suspected adverse reactions must be reported to TM.

Consult: TRAC Poster for Transfusion Reaction Management Transfusion Reactions – Types, Symptoms and Causes How to Report a Transfusion Reaction

• For Outpatient transfusions, Patient information sheet “Heading Home After Transfusion” should be provided Forms Management Catalogue NS 7360 (Adults) NS 7445 (Pediatric)

REFERENCES & FURTHER INFORMATION

Information for this document includes excerpts references listed. Refer to links for additional details. • Canadian Blood Services Circular of Information Bloody Easy 4: A Guide to Transfusion Medicine

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This is a controlled document. Any copies appearing in paper form must be checked against the electronic version prior to use. This resource has been created specifically for LHSC/SJHC and may not be applicable for other centres. These documents are the intellectual property of LHSC/SJHC. They are not to be shared or duplicated without permission