TRALI/TACO Policy and Process

The following was my process at HMC Doha for TRALI/TACO.  It includes proactive measures to minimize the risk of TACO and the procedure for surveillance and workup of such cases.

In the Medinfo blood bank computer system, we did not prepare plasma or platelets from female donors.  If approved by a transfusion medicine physician, a manual override was made in exceptional cases (e.g. mother donating platelets for her child in neonatal alloimmune thrombocytopenia cases.).  In some other countries, they do HLA antibody testing to allow females to donate platelets.

I emphasize that the diagnosis of TRALI and/or TACO is clinical, but the transfusion medicine physicians must always consider the possibility whenever there is an adverse effect associated with progressive respiratory distress.

Principle:

Since TACO and TRALI are major causes of serious adverse effects from transfusions, this policy outlines actions being pro-actively taken to mitigate the risks in Transfusion Medicine.  TACO and TRALI may be difficult to distinguish so this policy addresses both.

Objectives:

  1. Implement measures to minimize TRALI and TACO
  2. Track cases of transfusion-associated acute lung injury TRALI and TACO
  3. Develop algorithms for suspected cases of TRALI and TACO

Tracking:

  1. All transfusion reactions are reviewed by the Division Head, Transfusion Medicine or his designee on a STAT basis, 24 hours a day, 7 days a week
  2. Any reactions with respiratory distress are reported as “rule-out TRALI/TAC” to the clinician
  3. All transfusion reactions are recorded in Medinfo HIIG for tracking and reporting.

Risk Management:

  1. Female blood donors routinely are only used for making RBC components (i.e. not for FFP, cryoprecipitate, or platelets).
  2. RBCs are in additive solution SAGM so only 35 ml residual plasma is present per unit.
  3. All platelet components are in platelet additive solution with only 35 ml residual plasma per component.
  4. All platelets and plasma are pathogen-inactivated which may reduce the risk of TRALI.
  5. If the female has a rare phenotype (e.g. IgA deficient, rare platelet antigen typing) she will only be considered for a directed donation of platelets or FFP/cryoprecipitate for that special-needs patient if she does not have HLA antibodies (anti-human-neutrophil antibody testing to be implemented in such cases when it is available on-site).
  6. Solvent-detergent treated plasma SDP is available for patients with a confirmed or suspected history of TRALI.
  7. All cellular components are leukodepleted (< 1E6 residual WBCs/component as per CE Standards) in the blood bank at the time of production.
  8. Blood bank computer system Medinfo Hematos IIG limits the number of components released at any one time (excluding emergencies).

Notifications:

  1. Transfusion Medicine TM will notify the outside blood supplier of any units implicated or associated with TRALI.
  2. A transfusion medicine physician will notify the most responsible physician of any workup results suggesting the possibility of TRALI/TACO.
  3. TM will notify all donors of their disqualification from blood donation based on the following algorithm.

Algorithm for Diagnosis and Management of Donors:

  1. Evaluation of the Donor and Recipient in Suspected TRALI:
    1. The medical technologist will process all transfusion reactions as STAT and immediately contact the TMS Director or physician designate with the results.
    2. The medical technologist will convey information to the TMS Director or designate about ALL blood components issued recently, especially in the last 6 hours prior to the event.
    3. The TMS Director or designate will specifically check if there is evidence of respiratory distress listed on the transfusion reaction investigation form.  If so, he will contact the responsible clinician immediately for further assessment.
    4. If the signs and symptoms suggest ALI (see Table 1 above), the TMS Director or designate will inquiry about the left atrial pressure to rule out left-sided heart failure as a cause for the pulmonary edema.
    5. Based on the clinical information, the TMS Director or designate may elect to order any or all of the following tests if available:
      1. Quarantine all remaining components from possibly implicated/associated donor(s) while the workup is in progress.
      2. Recipient HLA, platelet, and/or granulocyte antibody screen, or a crossmatch between recipient plasma/serum and donor leukocytes
      3. Donor HLA and/or platelet antibody screen, granulocyte antibody screen, crossmatch donor plasma/serum and recipient leukocytes, inter-donor crossmatch between plasma/serum of one and leukocytes of another donor.
      4. The usual algorithm to be followed is as follows:
        1. Consult patient medical record and clinical care physician to determine if the diagnosis of TRALI is likely.
        2. Check all components transfused within 6 hours prior to the onset of symptoms.’
        3. Immediately quarantine other components from the same donations and contact outside blood suppliers if indicated.
        4. Obtain donor antibody testing of only highly suspect cases, based on the clinical manifestation and initial diagnostic tests:
          1. If multiple units transfused within hours, only investigate components donated by multiparous females and/or last two units transfused.
          2. First test for presence of HLA class I and class II antibodies in donor components.
          3. If antibody positive, HLA type recipient’s lymphocytes to detect corresponding antigen or perform crossmatch with donor plasma and recipient lymphocytes.
          4. If HLA antibody negative, proceed with neutrophil-specific antibody testing of donor plasma.
        5. If matching antigen-antibody identified or if positive crossmatch, defer implicated donor immediately.
        6. If no such concordance found or if crossmatch is negative, donor eligible to continue donating.
        7. If no antibodies found in donor plasma, test recipient plasma for antibodies to HLA class I and II antigens:
          1. If recipient antibody positive, HLA type donor’s lymphocytes to detect corresponding antigen or perform crossmatch with recipient plasma and donor lymphocytes.
          2. If recipient HLA antibody negative, proceed with neutrophil-specific antibody testing of recipient plasma
  2. Donor Disposition:
    1. For donors implicated in TRALI or associated with multiple events of TRALI, one or more of the following options may be selected at the discretion of the Head, Transfusion Medicine or designate:
      1. Defer donor from donation
      2. Divert plasma for fractionation or discard plasma from future whole blood donations from that Blood and Apheresis Donor Main Questionnaire
      3. Manufacture no platelet or plasma components from that donor
      4. Wash or freeze/deglycerolize RBCs from that donor
      5. Permanently defer the donor from future plasmapheresis or plateletpheresis donations
      6. Evaluate the previous donations from that Blood and Apheresis Donor Main Questionnaire  Avoid giving the same recipient future transfusions from the same donor implicated in TRALI
      7. If the implicated unit(s) are from another facility, that blood center should be notified to initiate a workup for possible TRALI in the donor.
  3. Interpretation:
    1. The diagnosis of TRALI is not clear-cut:
      1. The AABB interim standard does not apply.  It is at the discretion of the TMS Director or designate whether to conduct donor assessments.
    2. The donor is associated with a single event of TRALI:
      1. This applies where the diagnosis of TRALI has been established based on clinical and radiographic findings:
      2. Each donor from each and every component associated with TRALI must be identified and traced.
      3. Co-components from the current donation and components from previous donations should be evaluated for recipient complications.
      4. The donors medical history should be evaluated for previous pregnancies, transfusions or other events that may have resulted in antibody development.
      5. Based on the results of this investigation, the Head, Transfusion Medicine or designate should decide:
        1. Whether to perform laboratory testing
        2. Whether to discard the remaining blood components from the donor
        3. Whether to allow or indefinitely defer the donor
    3. The donor is associated with multiple events of TRALI:
      1. This applies where the diagnosis of TRALI has been established based on clinical and radiographic findings:
      2. Each donor from each and every component associated with TRALI must be identified and traced.
      3. Co-components from the current donation and components from previous donations should be evaluated for recipient complications.
      4. The donors medical history should be evaluated for previous pregnancies, transfusions or other events that may have resulted in antibody development.
      5. Based on the results of this investigation, the TMS Director or designate should decide:
        1. Whether to perform laboratory testing
        2. Whether to discard the remaining blood components from the donor
        3. Whether to allow or indefinitely defer the donor
    4. Triage based on laboratory testing for TRALI:
      1. The donor associated with TRALI is antibody-negative:
        1. The donor may continue to donate.
      2. The donor associated with TRALI is antibody-positive but the specificity is NOT directed against a recipient antigen by either antigen typing or crossmatching (i.e. the donor is NOT implicated in TRALI—see definition above):
        1. Indefinitely defer the donor from all donations OR
        2. Allow donation of washed/frozen-deglycerolized RBCs only
      3. The donor is implicated in TRALI (see definition above):
        1. Indefinitely defer the donor from all donations OR
        2. Allow donation of washed/frozen-deglycerolized RBCs only
      4. The recipient has antibodies implicated in TRALI (determined by crossmatch or antibodies directed against specific HLA class I, HLA class 2, and/or human neutrophil antigens):
        1. The recipient must receive leukodepleted blood components
    5. TACO
      1. TACO is due to cardiac overload.  Our mitigations are to restrict release of the number of components outside emergency events.

References:

  1. AABB Association Bulletin 14-02, TRALI, Bethesda, MD, USA
  2. Han Y. and Goldfinger D., Transfusion Medicine TM 07-5 (TM-297) Checksample, American Society for Clinical Pathology, Chicago, IL, USA. July 2007
  3. Goldman M, Webert, KE, Arnold DM, et al., Transfusion Med Rev  2005; 19:2-31.
  4. Fung YL, Goodison KA, Wong JK, Minchinton RM., Investigating Transfusion-Related Acute Lung Injury (TRALI), Intern Med J. 2003 Jul;33(7):286-90.
  5. Standards for Blood Banks and Transfusion Services, Current Edition, AABB, Bethesda, MD, USA
  6. AABB Association Bulletin #05-09, Transfusion-Associated Acute Lung Injury, 11/8/05
  7. AABB Association Bulletin #05-04, Proposed Interim Standard for Deferral of Donors Implicated in TRALI, 9/3/05.
  8. TRM.42110, CAP Transfusion Medicine Checklist, 15/6/09