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Plasma Protein (Fractionation) Products

The general principles outlined in paragraphs 1 to 6 in the CMA Transfusion Guidelines will also apply to Plasma Protein (Fractionation) Products.  All of the products listed are available through Transfusion Medicine.

Albumin

There are limited indications for which albumin is of proven benefit. Crystalloid solutions are the initial resuscitation fluids of choice in most circumstances. When albumin is used, 5% is preferred over 25% except in specific circumstances where the avoidance of volume overload is a priority.

 

The following are indications for which there is some support12:

 

  • Post-operative liver resection patients with concomitant ascites.
  • Burns if adequate crystalloid therapy has failed and >12 – 24 hours have elapsed.
  • Post CABG for volume expansion.
  • Large volume paracentesis (5L) with refractory ascites.
  • Nephrotic syndrome/severe peripheral edema with diuretic resistance, in conjunction with diuretic therapy.
  • Patients with cirrhosis and subacute bacterial peritonitis requiring volume expansion.
  • Large volume plasma exchange.

 

There is NO evidence of benefit for the use of albumin in the following:

  • Initial therapy for fluid resuscitation in critically ill patients13.
  • Hypotension during hemodialysis.
  • Hypoalbuminemia.
  • Cerebral ischemia.
  • Nutritional support
  • Priming for cardio-pulmonary bypass.

 

Immune Globulin Preparations (I/M)

The following are suitable for I/M injection only, unless otherwise stated:

1. Immune Gamma Globulin (Human), GamaSTAN S/D

  • Passive antibody protection of susceptible individuals following exposure to certain disorders including hepatitis A and measles.
  • Prophylaxis against infection in congenital immunoglobulin deficiency (IVIG now usually used for this purpose).

2. Varicella Zoster Immune Globulin (Human), VariZIG

Indications:

  • For passive immunization of susceptible individuals, following significant exposure to varicella, to modify or prevent varicella infection where the individuals would be at a greater risk of complications from the disease. VariZIG may be given I/V or I/M.

Susceptible individuals include:

  • Immunocompromised individuals without a definite history of chickenpox or demonstrable antibody to varicella.
  • Primary immune deficiency disorders.
  • Individuals receiving immunosuppressive agents such as steroids or anti-cancer therapy.
  • Bone marrow transplant recipients regardless of history of chicken pox.
  • Newborn infants whose mothers develop chickenpox from 5 days before, to 48 hours following, delivery.
  • Hospitalized low birthweight infants (< 28 weeks gestation or < 1000 g) regardless of maternal history of chickenpox.
  • Hospitalized premature infants > 28 weeks gestation whose mothers are known not to have had chickenpox.
  • Pregnant women without a history of chickenpox or demonstrable antibody to varicella (Note:  There is no evidence that immunization prevents fetal infection or congenital varicella syndrome).

3. Hepatitis B Immune Globulin (Human) HBIG

Indications:

  • Post-exposure prophylaxis of individuals without known anti-HBs following significant exposure to HBsAg positive materials such as blood.  Significant exposure may occur as a result of skin laceration or puncture, mucous membrane contamination or transfusion.
  • Prophylaxis of infants born to HBsAg positive mothers.
  • Sexual contacts of an acute case of hepatitis B where the product can be administered within 2 weeks of the most recent sexual exposure. 
  • Sexual assault victims.
  • Infants (<1 year of age) whose mother, father or primary caregiver has acute hepatitis B or is a carrier of hepatitis B.

Intravenous Immunoglobulin

IVIG is licensed for use in:

  • Primary immune deficiency
  • ITP when a rapid rise in platelet count is needed to prevent or control bleeding
  • B-CLL patients with hypogammaglobulinemia and recurrent bacterial infections
  • Allogeneic bone marrow transplant patients
  • Pediatric HIV infections
  • Kawasaki disease

 

 

IVIG has been used for its immuno-modulatory effects for a large number of off-label indications with varying degrees of evidence of efficacy. The use of IVIG has shown a steady increase, more than doubling over the last 10 years in Canada, which is among the world’s highest IVIG users on a per capita basis. This is an expensive product that accounts for more than one third of Canadian Blood Services’ budget for fractionation and recombinant products.

 

Recently two separate Canadian expert panels were convened to develop evidence based practice guidelines for hematologic and neurologic conditions. Their recommendations are summarised in a recent paper15. Two additional Canadian panels are currently developing guidelines for IVIG use in primary immune deficiency and solid organ transplantation.

 

Currently acceptable indications for IVIG use are summarized in Table 2. Use of IVIG for other indications should generally occur only in the context of a properly constituted clinical trial.

Rh Immunoglobulin

Rh Immunoglobulin is indicated in the following circumstances:  A 300 ug dose is recommended unless otherwise stated.

1. Prophylaxis of Rh hemolytic disease of the newborn in pregnancy.

  • All Rh negative women at 28 weeks gestation, unless they have already formed anti-D.  If undelivered after 40 weeks, consider a further dose.
  • All Rh negative mothers of Rh positive babies within 72 hours of delivery.  Additional dosage will be recommended if the routine Rosette Test is positive and the Fetal-Maternal Hemorrhage Test shows greater than 30 mL fetal maternal hemorrhage.
  • All Rh negative women within 72 hours of therapeutic abortion, miscarriage, ectopic pregnancy, vaginal bleeding in pregnancy, amniocentesis, abdominal trauma, or external version.

2. Rh immunoglobulin should be considered for all Rh negative women of child bearing potential who receive a transfusion of Rh positive red cells or platelets.  The dose is dependent on the volume given and will be recommended by the Transfusion Medicine Division Head.

3. May be considered as an alternative to intravenous immune globulin in the treatment of ITP in Rh positive patients.

4. Rh immunoglobulin must be given to Rh negative patients after the initial transfusion of Rh positive platelets, then after every 6 adult platelet doses (6 apheresis units or 6 pools) of Rh positive platelets. It is recommended that Rh immunoglobulin be given if it has been 3 weeks since the last dose of Rh immunoglobulin  and the patient will be receiving Rh positive platelets. 

 

 

Coagulation Factor Concentrates

These should usually be ordered in consultation with a Hematologist.  Available concentrates are summarized in Table 3

Octaplex (FII/ VII/ IX/ X concentrate)

This product that is derived from large pools of human plasma is indicated for the treatment of bleeding and peri-operative prophylaxis of bleeding in acquired deficiency of prothrombin complex coagulation factors such as deficiency caused by vitamin K antagonists or in the case of overdose of vitamin K antagonists, when rapid correction of the deficiency is required. 

Octaplex  should only be used when rapid correction of the deficiency is necessary, such as major bleeding or emergency surgery.  In other cases reduction of the dose of vitamin K antagonsist and/or administration of vitamin K is usually sufficient.

Note that treatment with plasma derived products that contain factors II, VII, IX and X has been associated with thrombosis and may be associated with an increased risk of DIC and thrombo-embolic complications including myocardial infarction.

 Contraindications:

  • Hypersensitivity to the drug or any ingredient
  • Patients suffering from heparin induced thrombocytopenia or allergy to heparin
  • Recent myocardial infarction, with a high risk of thrombosis or with angina except in life-threatening bleeding due to oral anticoagulant overdose, or when emergency surgery is indicated in patients on Vitamin K antagonists and INR >3
  • DIC
  • Not recommended for the treatment of bleeding disorders in parenchymal liver disease or esophageal varices or major liver surgery 

Dosage:

Only general dosage guidelines are given that are suitable for use in bleeding and prophylaxis of bleeding during vitamin K antagonist treatment.  The dose will depend on the pre-treatment INR and the targeted INR.

INR                             2-2.5                2.5-3                3-3.5                >3.5

Dose* ml/Kg               0.9-1.3             1.3-1.6             1.6-1.9             >1.9

 *Maximum single dose is 3,000 IU (120 ml Octaplex)

  

Other Concentrates

1. Protein C Concentrate

This product is not licensed and must be obtained through the Special Access Program (SAP).

2. C1 Esterase Inhibitor Concentrate (BERINERT P)

This product is not licensed and must be obtained through the Special Access Program (SAP).

3. Anti-thrombin III Concentrate