Guidelines for Autologous Transfusion.

I. Preoperative Autologous Blood Deposit for Defined Use

Scientific Committee, The Hong Kong Association of Blood Transfusion and Haematology Drafted by the Preoperative Autologous Transfusion Working Group. H.W. Liu1(Convenor), K.F. Wong2, Raymond Chu3, C.K. Lin4, Cindy Chan5.

1.000 Preoperative Autologous Blood Deposit (PABD) for Defined Use
1.100 Introduction
1.110 This guideline was written after wide consultation and a pilot study initiated by the HK Red Cross Blood Transfusion Service. Several contentious issues have been identified, particularly the need for infectious screening, eligibility of patients who are positive for one of the viral markers, and crossover of unused autologous units. The following recommendations represent our deliberated approach to ensure safety of autologous transfusion. They are not meant to be restrictive especially in relation to those issues which are still currently under debate.
1.120 This guideline is about the use of pre-operative deposited blood as an alternative to allogeneic blood in elective surgery. It applies to whole blood stored in CPDA-1 or red cells stored in an additive solution at 2 - 6 °C for up to 35 and 42 days.
1.130 Autologous transfusion has the following advantages. It eliminates viral and parasitic transmission, prevents immune-mediated reactions, allo-immunisation and the potential immune modulatory effects. It is, however, not totally safe as risks of bacterial contamination and clerical error still remain. As the risk of transfusion transmissible infection in Hong Kong is very small, one must carefully balance the benefit to be gained from autologous transfusion to the risk of delaying surgery and subjecting patients to repeated phlebotomies. As PABD involves many parties, it is important to define clearly their responsibilities in order to avoid clerical errors.
1.200 Indication
1.210 Autologous transfusion should only be offered to patients undergoing elective surgery who have a reasonable likelihood of requiring transfusion. Operations which normally need 'Type and Screen' only should not be considered.
1.220 It is essential to consider the risk of delaying surgery, the time interval available, the expected blood loss and the patient's fitness to undergo several blood donations within a relatively short period of time before offering PABD to a patient.
1.300 Patient eligibility
1.310 The patient should be free from cardiovascular, cerebrovascular and respiratory diseases and must have a haemoglobin level of >= 11.0 g/dl. In general, a patient who is fit enough to undergo elective surgery should be able to donate blood preoperatively.
1.320 There is no specific age and weight limit but the patient must have good venous access, can comprehend and is willing to cooperate.
1.400 Exclusion Criteria
1.410 Contraindications
  1. Unconfirmed or unreliable surgical date.
  2. Anaemia.
  3. Poor venous access.
  4. Active infection.
1.420 Relative Contraindications
  1. Cardiovascular disease: Ischaemic heart disease (left main coronary artery disease, recent angina, unstable angina, myocardial infarction within last 6 months). Critical stenotic valvular disease. Cyanotic heart disease. Ventricular arrhythmia. Congestive heart failure.
  2. Uncontrolled hypertension (systolic > 180 mmHg, diastolic > 100 mmHg).
  3. Respiratory disease: restrictive or obstructive lung diseases
  4. CNS disease: Cerebral tumor. Epilepsy. History of stroke or transient ischaemic attacks.
  5. Pregnancy with: impaired placental blood flow, intrauterine growth retardation, pregnancy related hypertension, pre-eclampsia, cardiac disease, respiratory disease, renal disease, insulin dependent diabetes.
  6. Patients with virological markers indicating infectivity for hepatitis B, hepatitis C, HIV or HTLV.
  7. Adverse reactions to phlebotomy.
1.430 Temporary deferral
Patients with conditions that are potentially infectious or after invasive procedure that may induce transient bacteraemia should be deferred temporarily.
1.440 High risk patients
High risk patients should be bled in hospitals under medical supervision, with resuscitation facility available throughout the procedure.
1.500 Consent
1.510 The patient or, in the case of minor, the legal guardian must give written consent for autologous donation (and blood test if required).
1.520 The interviewer must ensure that the patient understands all the information given and has ample opportunity to ask questions and has them answered. It is important to explain: (i) The risks and merits of autologous and allogeneic transfusion. (ii) The range of tests to be performed, particularly the infectious markers. (iii) The necessity to have the patient's permission to disclose test results to the patient's physician. (iv) That whether the blood will be transfused is subjected to clinical indication and that all unused autologous blood will be discarded. (v) The possibility of supplemental homologous transfusion.
1.530 The provision of written information on autologous transfusion is highly recommended.
1.600 Blood Collection
1.610 Safety
1.611 The physician in charge of the program should determine the patient's suitability to donate in blood bank or hospital settings.
1.612 Patients should be asked to bring along a friend or relative to accompany them home, in case they might experience vasovagal reactions.
1.620 Donation schedule
1.621 This is governed primarily by the operation date and the shelf life of the blood components. Suitable patients may deposit up to 5 units of blood for their own use in the 5 weeks preceding surgery.
1.622 Once enrolled into the program, the patient should continue to receive iron supplement till the operation.
1.623 Each blood donation must be separated by a minimum of 7 days with the last donation at no less than 72 hours before surgery.
1.624 The referring doctor and the hospital blood bank should be closely informed of the progress, in particular if the specified number of autologous units cannot be met for.
1.630 Predonation check
1.631 Prior to each donation, the phlebotomist must check: (i) donor's identity; (ii) health history; (iii) that donor is not hungry or thirsty; (iv) temperature, BP, pulse and Hb.
1.632 Blood should only be drawn if patient is afebrile, has normal BP and pulse and Hb of greater than 11g/dl.
1.640 Protection against contamination
Preparation of the skin for venepuncture should achieve surgical cleanliness to provide maximum assurance of a sterile product.
1.650 Donation volume
1.651 The volume withdrawn at any one time should not exceed 13% of the estimated blood volume as calculated by BW (kg) x 71 ml/kg, the upper limit being 470ml including test samples. Patients under 50 kg should bleed proportionally less.
1.652 The volume drawn should be in proportion to the amount of anticoagulant present. Select the appropriate blood pack or adjust the volume of anticoagulant present. Standard 450ml packs contain 63 ml anticoagulant are designed for 450 ± 45 ml donation. Under collection from 300 to 404 ml must be processed into red cell components. If less than 300 ml is to be collected, it is necessary to use smaller packs or to reduce the amount of anticoagulant accordingly. The right amount of anticoagulant is calculated by: [ (volume to be collected in ml/450) x 63 ml ]
1.700 Laboratory Testing
1.710 Donor testing
1.711 ABO and Rh D grouping are mandatory on all pre-deposited units.
1.712 It is recommended to perform infectious screen as in the case of homologous donation to establish the patient's status prior to transfusion. Although transfusion transmissible infection does not constitute an absolute contraindication to autologous transfusion, its presence reduces the benefit to be gained and poses potential risk to health care staff and other patients, in case the blood is inadvertently issued for homologous transfusion.
1.713 In view of the risk of asymptomatic bacteraemia, it is advisable to perform blood culture on the units collected.
1.720 Pretransfusion testing
1.721 The hospital blood bank should confirm the unit's blood group as for homologous blood.
1.722 Autologous transfusion does not negate compatibility testing. Prior to surgery, a blood sample should be obtained from the patient for compatibility test to be performed against every unit of autologous blood. This will ensure ABO compatibility. As patient may need additional homologous transfusion, type and screen is more appropriate than conventional crossmatch.
1.800 Storage
Autologous blood should be stored in blood bank type refrigerators at 4 ± 2°C under continuous monitoring. It must be physically separated from the homologous blood stock.
1.900 Labelling and Issue
1.910 Autologous blood must bear a special label in addition to the usual blood group and product labels. This label should be easily recognisable and contain the following information: (i) The message "For autologous use only, not suitable for other patients". (ii) Patient's full name (as appear in the HKID card). (iii) HKID number. (iv) Sex. (v) Date of birth. (vi) Hospital. (vii) Date of collection. (viii) Scheduled operation date. (ix) Patient's signature.
1.920 Autologous blood should bear a biohazard label if indicated
1.930 There should be an established blood bank procedure to track the autologous blood to their intended recipients.
2.000 Disposal of Unused Blood Units
We recommend not to crossover unused autologous blood to other patients. Whole blood and red cells should be disposed of upon patient discharge or expiry in manner compatible with regulations governing biological waste disposal. They may be used for laboratory purposes, provided that tests for syphilis, anti-HIV, anti-HTLV-1, anti-HCV and HBsAg are non-reactive. Unused plasma should not be sent for fractionation. They should be discarded upon patient's discharge.
2.100 Records
All consent forms, donation records and transfusion records must be handled as for homologous transfusion. The outcome of all autologous blood should be documented to ensure that each unit can be accounted for.

Acknowledgment
The Working Group thanks Drs. HM Chiu, OM Chung, WS Chu, KK Ho, HW Lai, KY Leung and KP Ng of Queen Elizabeth Hospital for specialist advice.

Comments
We welcome comment to assist the review process. All correspondance regarding the guidelines should be addressed to: Scientific Committee, The Hong Kong Association of Blood Transfusion and Haematology. c/o Dr HW Liu, 15 King's Park Rise, Yaumatei, KLN.

References

  1. The National Blood Resource Education Program Expert Panel. The Use of Autologous Blood. JAMA, 1990, 263: 414-417.
  2. Kruskall MS, Bodner MS, Dzik WH, et al. An annotated bibliography on autologous transfusion. Transfusion, 1992, 32: 286-290.
  3. British Committee for Standards in Haematology and Blood Transfusion. Guidelines for autologous transfusion. I. Pre-operative autologous donation. Transfusion Medicine, 1993, 3: 307-316.
  4. Controversies in transfusion medicine. Is autologous blood transfusion worth the cost. Transfusion, 1994, 34: 75-83.
  5. Scientific Subcommittee of The Australian Society of Blood Transfusion Inc. Guidelines for Pre-operative Autologous Blood Collection. Topics in Transfusion Medicine, 1996, Vol 3, No.1.

1Consultant, HKRCBTS
2Consultant Haematologist, QEH
3Consultant Haematologist, PYNEH
4HCE, HKRCBTS
5SMT, Components Production Laboratory, HKRCBTS