WS/T 623-2018Transfusion of whole blood and blood components (English PDF)
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Issued by
National Health Commission
Level / Type
National · Recommended
Issue date
September 26, 2018
Implementation date
April 1, 2019
Scope
WS/T 623-2018 (Transfusion of whole blood and blood components) is available as an English-translated PDF.
WS/T 623-2018 — This standard specifies the indications, infusion doses and methods of use of whole blood and component blood. This standard applies to the whole process of clinical transfusion therapy in medical institutions.
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Document preview — WS/T 623-2018
National Standard of the People's Republic of China
- ICS
- 11.020
- Classification
- C 05
Issued by: National Health Commission
Contents
- Foreword
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 Abbreviations
- 5 General
- 5.1 Irreplaceable principle
- 5.2 Minimum dose principle
- 5.3 Individualized infusion principles
- 5.4 Safety infusion principles
- 5.5 Reasonable infusion principle
- 5.6 Effective infusion principle
- 6 Characteristics and methods of use of whole blood and blood components
- 6.1 Whole blood
- 6.2 Red blood cells
- 6.3 Platelets
- 6.4 Plasma
- 6.5 Cold precipitation
- 6.6 Apheresis
- 6.8 Irradiated blood
- 7 Adverse reactions to blood transfusion
- 8 Precautions
- 8.1 Use time and infusion rate
- 8.2 Blood transfusion equipment
- 8.3 Drug Addition
- 8.4 Blood warming
Foreword
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard is formulated in accordance with the Blood Donation Law of the People's Republic of China and the Measures for the Management of Clinical Blood Use by Medical Institutions.
This standard was drafted. Institute of Blood Transfusion, Chinese Academy of Medical Sciences, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Chinese Academy of Medical Sciences Foreign Cardiovascular Hospital, Cancer Hospital of Chinese Academy of Medical Sciences, Huashan Hospital affiliated to Fudan University, West China Hospital of Sichuan University, and blood of Jiangsu Province Heart, Shenzhen Blood Center.
1 Scope
This standard specifies the indications, infusion doses and methods of use of whole blood and component blood.
This standard applies to the whole process of clinical transfusion therapy in medical institutions.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version is appropriate.
Used in this document. For undated references, the latest edition (including all amendments) applies to this document.
GB 18469 Whole blood and component blood quality requirements WS/T 203 common terminology for transfusion medicine WS/T 433-2013 Intravenous Therapy Technical Practice
3 Terms and definitions
The following terms and definitions defined in GB 18469 and WS/T 203 apply to this document.
Massive blood loss
Loss of one's own blood volume within 24h (7% of normal adult weight; 8% to 9% of children's weight); or 50% within 3h Self-blood volume; or adult bleeding rate of 150mL/min; or bleeding rate of 1.5mL/(kg · min) more than 20min;
Blood loss results in a systolic blood pressure below 90 mm/Hg or an adult heart rate in excess of 110 beats/min.
Common frozen plasma A type of frozen plasma that contains a stable coagulation factor.
To cryoprecipitate plasma cryoprecipitate One type of frozen plasma, also known as cold supernatant, separates plasma from cryoprecipitate clotting factors from fresh frozen plasma.
4 Abbreviations
The following abbreviations apply to this document.
APTT. activated partial thromboplastin time DIC. disseminated intravascular coagulation Hb. hemoglobin Hct. hematocrit INR. international normalized ratio PT. prothrombin time SCID. severe combined immune deficiency TACO. transfusion associated circulatory overload TA-GVHD. transfusion associated graft-versus-host disease TRALI. Transfusion related acute lung injury TTP. thrombotic thrombocytopenic purpura vWF. von Willebrand factor
5 General
5.1 Irreplaceable principle
Blood transfusion therapy is only considered when blood transfusion can relieve the condition and treat the patient's disease.
5.2 Minimum dose principle
The clinical blood transfusion dose should consider the minimum dose that the infusion can effectively alleviate the condition.
5.3 Individualized infusion principles
Clinicians should develop optimal transfusion strategies for the specific conditions of different patients.
5.4 Safety infusion principles
Blood transfusion therapy should be based on safety and avoid additional injury to the patient.
5.5 Reasonable infusion principle
The clinician should pre-transfusion assessment of the patient and strictly control the indication for transfusion.
5.6 Effective infusion principle
Clinicians should analyze the effects of transfusion after the patient, evaluate the effectiveness of the infusion, and provide a follow-up treatment plan.
in accordance with.
6 Characteristics and methods of use of whole blood and blood components
6.1 Whole blood
6.1.1 Features
The composition of the whole blood preparation is basically the same as that of the circulating blood in the body. After the collection, the blood in the whole blood is small with the extension of the storage period.
Plates and unstable coagulation factors gradually lose their biological activity. Currently there are few clinical applications.
6.1.2 Features
Improve blood oxygen carrying capacity and increase blood volume.
6.1.3 Indications
Suitable for patients with large blood loss and blood replacement.
Not suitable for patients who meet the indications for blood transfusion; it is also not suitable for the treatment of coagulopathy, simple expansion of blood volume, Promote wound healing or improve the body condition.
6.1.4 Principle of infusion
The infusion was performed according to the principle of ABO and RH isotype and crossmatching.
6.1.5 Infusion dose
The infusion dose depends on the amount of blood loss, the rate of blood loss, tissue hypoxia, and the like.
6.2 Red blood cells
6.2.1 Features
Improve blood oxygen carrying capacity and alleviate clinical symptoms caused by hypoxia.
6.2.2 Indications
It is suitable for improving the symptoms of hypoxia caused by chronic anemia or acute blood loss. It can also be used for blood replacement, such as severe newborns.
Hemolytic disease, parasitic infections (malaria, Babesiasis, etc.), sickle cell anemia, etc. [3].
Not suitable for drug-effective anemia; nor should it be used to expand blood volume, promote wound healing, or improve human body shape State of treatment.
6.2.3 Common types of red blood cell preparations
The characteristics and indications of common types of red blood cell preparations are shown in Table 1.
Table 1 Characteristics and indications of common types of red blood cell preparations
Indication of product name Concentrated red blood cells minimize blood volume and reduce the blood circulation of recipients Load and reduce the impact of blood additives on patients Suitable for patients with high risk factors of cyclic overload, such as charge Patients with bloody heart failure, infants, etc.
Washing red blood cells Removed more than 98% of plasma from whole blood, which can be reduced Transfusion adverse reactions such as sensitive and non-hemolytic febrile reactions Applicable to the following patients to improve chronic anemia or acute blood loss Hypoxia symptoms.
a) patients who are allergic to plasma components;
b) patients with IgA deficiency;
c) patients with non-homologous hematopoietic stem cell transplantation;
d) patients with hyperkalemia and liver and kidney dysfunction;
e) Neonatal blood transfusion, intrauterine transfusion and blood transfusion.
Frozen and thawed
Glycerol red blood cell Frozen red blood cells have a long shelf life;
Thawing and washing process removes most white blood cells and plasma Suitable for patients with rare blood types and patients with special conditions Storage and use of red blood cells Suspension red blood cell Hct moderate (0.50~0.65), the infusion process is relatively stream Suitable for chronic anemia or acute blood loss other than the above patients patient
6.2.4 Indication of infusion
6.2.4.1 Patients with hemodynamic stability
See Table 2 for signs of red blood cell transfusion in patients with hemodynamic stability. Formulating a blood transfusion strategy should also refer to clinical symptoms, Hb Level, cardiopulmonary function, tissue oxygen supply, and oxygen consumption should not be used as the only indication of infusion of red blood cell components.
Table 2 Hemodynamically stable patients with red blood cell transfusion indications
Hb level suggests clinical performance >100g/L is not recommended for special cases of infusion (such as patients with severe heart and lung function), which is determined by the clinician according to the patient's condition.
Whether to infusion
80g/L ~
100g/L
Generally do not need to lose Note, special circumstances can be Consider an infusion Postoperative or patients with cardiovascular disease with clinical symptoms (chest pain; orthostatic hypotension or fluid) Tachycardia with ineffective resuscitation; congestive heart failure due to anemia, etc.);
Thalassemia major;
Sickle cell anemia patients before surgery;
Acute coronary syndrome, etc.
70g/L ~
80g/L
Comprehensive assessment of each Factors can be considered Infusion Postoperative Cardiovascular disease, etc.
< 70g/L Considering intensive care monitoring, etc.
< 60g/L Recommended for infusion of symptomatic chronic anemia patients with Hb< 60g/L may consider reducing symptoms through blood transfusion and reducing anemia Risk Asymptomatic patients with chronic anemia should take other treatments, such as medication, etc.
Note. High altitude areas and infants and young children can increase the Hb threshold according to the condition.
6.2.4.2 Active bleeding patients
In patients with active bleeding, the clinician decides whether to infuse red blood cells based on the bleeding and hemostasis.
6.2.5 Principle of infusion
6.2.5.1 Concentrated red blood cells and suspended red blood cells are infused according to the ABO isotype and cross-matching compatibility principle.
6.2.5.2 Wash red blood cells, freeze and thaw glycerol red blood cells according to the principle of cross-matching main compatibility, preferential selection Choose ABO isotype infusion.
6.2.6 Infusion dose
6.2.6.1 When there is no active bleeding in the patient, the dose of red blood cells used depends on the condition and the expected Hb level. Infusion 1U Erythrocytes can increase Hb levels in adults weighing 60 kg by about 5 g/L (or increase Hct by about 0.015). Infants can lose every time
Note 10mL/kg ~ 15mL/kg, Hb level increased by 20g/L ~ 30g/L.
6.2.6.2 When the patient is in active bleeding, the dose of red blood cell infusion depends on the amount of blood loss, blood loss rate and tissue hypoxia condition.
6.2.6.3 Washing red blood cells, freezing and thawing glycerol red blood cells, etc. will lose some red blood cells during processing.
Appropriate increase.
6.3 Platelets
6.3.1 Features
Prevent or treat bleeding or bleeding tendency due to decreased platelet count or dysfunction.
6.3.2 Indications
Applicable to coagulation dysfunction caused by decreased platelet count or dysfunction.
Not suitable for bleeding that is not associated with decreased platelet count or dysfunction, nor for autoimmune thrombocytopenia Symptoms, TTP, or heparin-induced thrombocytopenia unless bleeding is life threatening.
6.3.3 Common types of platelet preparations
The common types and characteristics of platelet preparations are shown in Table 3.
Table 3 Common types and characteristics of platelet preparations
Product name
Platelets prepared by concentrating platelets from whole blood, high in concentration and purity, isolated from.200 mL of whole blood the prepared platelet content is >=2.0×1010, see GB 18469;
Generally need to use multiple bags in combination Mixed platelets with two bags of concentrated platelets and two or more bags of concentrated platelets collected in the same blood bag, small blood Plate content >= 2.0 × 1010 × mixed unit number, see GB 18469.
Apheresis platelets are collected from a single blood donor's circulating blood using a blood cell separator with high purity and platelets containing the amount is >= 2.5 × 1011/therapeutic dose, see GB 18469;
Compared with mixed concentrated platelets, the incidence of allogeneic immune responses can be reduced.
6.3.4 Infusion indications
6.3.4.1 Conventional infusion indications
See Table 4 for indications for platelet transfusion.
Table 4 indications for platelet transfusion
Clinical manifestations of platelet count <=100×109/L neurosurgery or ophthalmic surgery;
Cardiac and thoracic surgery patients with abnormal blood coagulation indicators, accompanied by a large number of microvascular bleeding.
<=80×109/L intraspinal anesthesia.
<=50×109/L Acute blood loss or invasive operation (elective diagnostic lumbar puncture and non-axonal surgery, etc.).
<=20×109/L central venous catheter placement;
Non-bleeding patients with unstable conditions (such as fever or infection).
<=10×109/L Non-bleeding patients with stable disease to prevent spontaneous bleeding.
6.3.4.2 Cardiopulmonary bypass surgery
In patients with cardiopulmonary bypass and normal function cardiopulmonary bypass surgery, conventional prophylactic transfusion of platelets is not recommended. If suffering There is thrombocytopenia and/or platelet dysfunction, and platelet transfusion is recommended during perioperative bleeding.
6.3.4.3 Use of antiplatelet drugs
Conventional prophylactic transfusion of platelets is not recommended in patients with antiplatelet drugs when normal platelet function is normal;
Prophylactic infusion can be considered, and bleeding should be infused when life is critical.
6.3.4.4 Platelet dysfunction
Congenital or acquired platelet dysfunction in critical areas of bleeding or major surgery, regardless of platelet count water Platelet transfusion should be performed in all cases. When platelet dysfunction is not related to platelets itself (eg uremia, vascular blood) Cardiac disease, hyperglobulinemia, etc.) generally do not infuse platelets.
6.3.5 Principle of infusion
6.3.5.1 Infusion according to the principle of ABO, if the bleeding is life-threatening and there is no platelet, consider the infusion compatibility Sexual platelets.
6.3.5.2 When platelet transfusion is ineffective, platelet matching can be performed to select compatible platelets.
6.3.5.3 Platelets should be infused in sufficient quantities at one time.
6.3.6 Infusion dose
6.3.6.1 When the patient has no active bleeding, the infusion dose depends on the number of platelets before the patient is infused and the expected platelet count.
number. Usually a single infusion of a therapeutic dose per adult.
6.3.6.2 When the patient is in active bleeding, the infusion dose of platelets depends on the patient's bleeding and hemostasis.
6.3.6.3 Infusion of a therapeutic dose of platelets, adult (70kg) can increase 4 × 109/L ~ 8 × 109/L platelets, children (18kg) can be increased by about 17 × 109/L; infants and young children transfused platelets 5mL/kg ~ 10mL/kg, platelets can be elevated 40 × 109/L ~ 80 × 109/L.
6.4 Plasma
6.4.1 Features
Supplementation of coagulation factors, prevention or treatment of clotting factor deficiency causes bleeding or bleeding tendency.
6.4.2 Indications
When there is no corresponding clotting factor concentrate preparation, it can be used for a variety of causes of clotting factor deficiency, and can also be used for a large number of Blood transfusion, extensive burns, trauma, plasma exchange, etc.
Not suitable for simply expanding blood volume and increasing protein concentration, nor for other methods (such as vitamin K, cold) Coagulation disorders treated by precipitation of coagulation factors, clotting factor concentrates, etc.).
6.4.3 Common types of plasma preparations
The characteristics and indications of common types of plasma preparations are shown in Table 5.
Table 5 Characteristics and indications of common types of plasma preparations
Indication of product name Fresh frozen plasma contains all coagulation factors suitable for supplementation of coagulation factor deficiency Lack of bleeding or bleeding Single fresh frozen plasma with fresh frozen plasma as above Virus inactivated fresh frozen plasma Reduce the risk of transfusion-transmitted diseases, but will lose some coagulation factors, especially it is an unstable coagulation factor (V and VIII) Same as above, it is advisable to increase the dosage Ordinary frozen plasma Lack of unstable coagulation factors (V and VIII) compared to fresh frozen plasma for supplementation of stable coagulation factor the virus inactivates frozen plasma to reduce the risk of transfusion-transmitted diseases, but will lose some coagulation factors as above, and should increase the dosage.
Cold precipitation plasma Lack of factor VIII, factor XIII, vWF, fiber compared to fresh frozen plasma Protein and fibronectin; but albumin and other coagulation factors Fresh frozen plasma content is equivalent Infusion for patients with TTP Plasma exchange
6.4.4 Infusion indications
6.4.4.1 Plasma infusion should be based on coagulation function test results and clinical bleeding. PT is greater than the normal range of 1.5 Infusion of plasma may be considered when the doubling and/or APTT is greater than 1.5 times the upper limit of the normal range, or when the INR is greater than 1.7. Coagulation test results are not when it is easy to obtain, the clinician decides whether to infuse plasma according to the patient's bleeding condition.
6.4.4.2 Plasma infusion is recommended for patients with intracranial hemorrhage treated with warfarin.
6.4.5 Principle of infusion
Infusion according to the principle of cross-matching sub-side compatibility, blood donors with irregular antibody screening negative plasma can directly perform ABO Compatible infusion. ABO homoplasmic plasma is preferred.
6.4.6 Infusion dose
It is determined by the clinical condition and the patient's body weight, usually 10 mL/kg~20 mL/kg for adults and 10 mL/kg~15 mL/kg for infants.
For the treatment of a variety of clotting factor-deficient diseases, refer to the laboratory coagulation function test results.
6.5 Cold precipitation
6.5.1 Features
Supplementation of factor VIII, factor XIII, vWF, fibrinogen and fibronectin.
6.5.2 Indications
It is mainly suitable for bleeding caused by fibrinogen deficiency, and can also be used for the lack of factor VIII when using non-specific concentrated preparations.
Abuse, XIII deficiency, von Willebrand disease, fibrin abnormalities, and fibrinogen deficiency; can also be used in large numbers Hemorrhage due to transfusion, DIC, and other treatments that are ineffective.
Cold-precipitating coagulation factors should not be the preferred treatment option when specific concentrated preparations are available.
6.5.3 Indication of infusion
When a large amount of blood transfusion or DIC with fibrinogen level < 1.0g/L, cryoprecipitate factor can be infused. Trauma, obstetrics and Fibrinogen is maintained at 1.5g/L to 2.0g/L in patients undergoing cardiac surgery.
6.5.4 Principle of infusion
Infusion according to the principle of cross-matching sub-side compatibility, blood donors with negative antibody screening negative cryoprecipitate factor can be straight Follow the ABO compatible infusion.
6.5.5 Infusion dose
The infusion dose and frequency depend on the rate of fibrinogen consumption, recovery time, and half-life. Fibrinogen in no other in the case of consumption (such as bleeding, DIC, etc.), the half-life is about 4d. Usually adults infuse 2U every 5kg~10kg, infants and young children lose
Note 2U/kg~4U/kg. (1U. prepared from plasma isolated from.200 mL of whole blood and in accordance with GB 18469 quality requirements.)
6.6 Apheresis
6.6.1 Features
Improve the body's ability to resist infection.
6.6.2 Indications
Applicable to patients with infection, antibiotic treatment for 48h and neutrophil absolute value less than 0.5×109/L and congenital Patients with neutrophil dysfunction (such as chronic granulomatosis).
It is not suitable for the treatment of effective antibiotic treatment, nor for the reconstruction of granulocytes after bone marrow transplantation.
6.6.3 Principle of infusion
6.6.3.1 Infusion according to the principle of ABO isotype; if the patient has an allogeneic immune response or the infusion is ineffective, the leukocyte can be infused the antigen-matched donors were single-granulocytes.
6.6.3.2 Single granulocyte preparations should be infused after irradiation.
6.6.4 Infusion dose
Adults and older children are recommended to infuse a dose of 4×1010~8×1010 granulocytes per infant.
1 × 109 ~ 2 × 109 granulocytes/kg. The frequency of granulocyte infusion should refer to the patient's condition, usually once a day, and 1 in case of serious infection.
2 times a day, infusion 4d ~ 6d until the infection is controlled.
6.7 to leukocyte blood
6.7.1 Features
Reduce non-hemolytic febrile response, leukocyte antigen immunoreactivity and cytomegalovirus (CMV) and human T lymphoid Cytovirus (HTLV)-I/II infection, etc.
6.7.2 Indications
It is suitable for pathogens that require multiple blood transfusions, a history of non-hemolytic fever, and low immunity to CMV.
Patients and so on.
Not suitable for preventing TA-GVHD.
6.7.3 Principle of infusion
Same as the same type of non-leukocyte blood preparation.
6.8 Irradiated blood
6.8.1 Features
TA-GVHD occurs in patients with low immune function.
6.8.2 Indications
Intrauterine exchange of blood and intrauterine transfusion; pediatric patients with known or suspected immunodeficiency; congenital cellular immunodeficiency (eg SCID, congenital thymus and parathyroid hypoplasia) and Hodgkin's disease; granulocyte infusion; blood transfusion between relatives (not subject to pro Relationship between the distance and the immune status of the patient); blood component infusion of human leukocyte antigen (HLA) matching; acceptance Transplantation of patients with blood transfusion; patients are receiving treatment to inhibit T cell function (such as purine nucleoside drug - fludarabine, Bendamustine, azathioprine, alemtuzumab, etc.).
Same as the same type of non-irradiated blood preparation.
6.8.3 Principle of infusion
Same as the same type of non-irradiated blood preparation.
7 Adverse reactions to blood transfusion
Blood transfusion therapy may cause adverse symptoms such as fever and allergies. Medical staff should effectively identify and report adverse reactions of transfusion.
Type and deal with it effectively. The clinician can select the corresponding blood preparation according to the characteristics of different blood components to reduce the incidence of adverse reactions.
Birth rate.
The classification of adverse reactions of transfusion mainly includes transfusion-related cyclic overload, transfusion-related acute lung injury, and blood transfusion-related respiration.
Difficulties, allergic reactions, blood transfusion-related hypotensive reactions, non-hemolytic febrile reactions, acute hemolytic transfusion reactions, delayed onset Hemolytic transfusion reaction, delayed plasma reaction, transfusion-associated graft-versus-host disease, post-transfusion purpura, infectious transfusion Reaction, other/unknown.
8 Precautions
8.1 Use time and infusion rate
8.1.1 After the whole blood and component blood are discharged from the warehouse, the infusion should be completed within 4 hours and should not be stored.
8.1.2 The infusion rate should be slow and fast first, the initial 15min slow infusion, closely monitor whether there is a transfusion adverse reaction, If there is no adverse reaction, the infusion is completed at the fastest rate that the patient can tolerate.
8.2 Blood transfusion equipment
For precautions for the use of blood transfusion equipment, see 6.6 and 6.7 of WS/T 433-2013.
8.3 Drug Addition
No drugs should be added to the blood preparation except for normal saline.
8.4 Blood warming
Blood warming should be performed when blood is exchanged, a large amount of blood is transfused, and a clinically significant cold agglutinin is present in the patient. blood A special blood warmer should be used for heating.
references
[1] Zhang Lianyang. What is a large amount of blood loss. Journal of Trauma Surgery, 2015, 1.35.
[2] BeverleyJ.Hunt, ShubhaAllard, David Keeling, etal.A practical guideline for the Haematological management of major haemorrhage.British Journal of Haematology, 2015, 170 (6) 788-803.
[3] Weinstein R.2012 Clinical Practice Guide on Red Blood Cell Transfusion.
[4] CarsonJL, GrossmanBJ, KleinmanS, et al for the AABB Clinical Ttransfusion Medicine Committee.Red blood cell transfusion. A clinical practice guideline from the AABB.Ann Intern Med, 2012, 157.49-58.
[5] Vassallo R, Bachowski G, Benjamin RJ, et al. A Compendium of Transfusion Practice Guidelines.2nd ed.American National Red Cross, 2013.
[6] Wong ECC, Josephson CD, Punzalan RC, et al. Pediatric Transfusion. A physician's Handbook.4th ed.Bethesda, MD. AABB Press, 2015.
[7] Kaufman RM, Djulbegovic B, Gernsheimer T, et al. Platelet Transfusio...
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