In Italia vengono utilizzate fino a 8.000 unità di sangue al giorno. Il sangue non è un tessuto riproducibile in laboratorio e risulta indispensabile in numerosi servizi ospedalieri e alla base di alcuni trattamenti e terapie. Sono quindi di vitale importanza le donazioni effettuate da donatori volontari che rappresentano quindi una garanzia per la salute dei pazienti che ricevono, anche in maniera assidua, grandi benefici dalle trasfusioni di emocomponenti o di emoderivati.

"Offri la vita"
“Offri la vita”

Al momento della prima donazione il potenziale donatore deve presentare un documento di identità al personale della segreteria dell’unità di raccolta o del servizio trasfusionale. Il personale eseguirà l’accettazione informatica del donatore e gli consegnerà un questionario anamnestico da compilare prima del colloquio con il medico.
Il medico infatti ha il compito di valutare le condizioni generali di salute e definire il giudizio di idoneità alla donazione. Verifica le informazioni anamnestiche e si occupa della misurazione dei parametri fisici quali pressione arteriosa, frequenza radiale e peso, procedendo alla registrazione sulla cartella clinica informatizzata nella quale vengono raccolti e costantemente aggiornati il giudizio di idoneità alla donazione, gli accertamenti diagnostici pre-donazione e l’esito dei controlli periodici.
Nello specifico il candidato donatore deve avere un peso non inferiore ai 50 Kg e un’età compresa tra i 18 e i 60 anni, eventuali variazioni vengono autorizzate dal medico responsabile. La pressione sistolica deve necessariamente essere compresa tra i 110 e i 180 mmHg, mentre la diastolica tra i 60 e i 100 mmHg. Inoltre il polso deve presentarsi ritmico, regolare e le pulsazioni comprese tra i 50 e i 100 battiti al minuto. Infine viene valutata la concentrazione di emoglobina che nella donna non deve essere inferiore ai 12,5 g/dl e nell’uomo ai 13-5 g/dl.

Prima della donazione viene acquisito il consenso informato del donatore che esprime il proprio consenso nel sottoporsi alla donazione sia di sangue intero che di aferesi. La struttura trasfusionale ha inoltre l’obbligo di fornire informazioni dettagliate riguardo malattie trasmissibili e comportamenti a rischio, permettendo al donatore di chiedere chiarimenti in qualunque fase della donazione e ritirarsi o rinviare la propria donazione.

Le fasi di raccolta e processazione del sangue intero e da aferesi risultano molto delicate e si servono di una serie di sistemi di controllo e sicurezza che hanno lo scopo di evitare eventuali scambi di informazioni relativi a donatori differenti in modo da tutelare l’operatore sanitario, il donatore e il paziente ricevente.

Prima della donazione si effettua l’ispezione dei dispositivi impiegati per la raccolta per accertarsi dell’assenza di difetti o alterazioni, questi devono essere conformi alla normativa vigente garantendo la prevenzione del rischio di contaminazione, devono essere etichettati in tutte le sue parti riportando il codice univoco del donatore e della donazione in atto e associati alle relative provette per ispezioni biologiche.

Donazione di sangue.
Donazione di sangue.

Si procede quindi con la detersione e disinfezione della cute e all’identificazione positiva del donatore immediatamente prima della venipuntura. Per ogni postazione attiva di prelievo del sangue sono disponibili bilance automatizzate basculanti che assicurano la miscela del sangue con l’anticoagulante contenuto nel kit di prelievo, la rilevazione del volume e il tempo di prelievo. Per l’aferesi invece devono essere utilizzati separatori cellulari che garantiscano sicurezza al donatore e qualità dei prodotti finali.
Al termine della donazione i circuiti di raccordo vanno saldati con sistemi idonei a prevenire il rischio di contaminazione e nel caso di anomalie nella raccolta, verrà valutato in un secondo momento, l’utilizzo del prodotto ottenuto.

Al momento della lavorazione delle sacche viene effettuata un’ispezione visiva per valutarne l’integrità, la presenza di emolisi, coaguli e di eventuali altre anomalie che porteranno alla segregazione e registrazione delle unità di sangue relative.
L’attività di frazionamento del sangue intero necessitano di un primo passaggio in centrifuga refrigerata per sacche e di sistemi automatizzati per la scomposizione del sangue intero che rilevino almeno i volumi dei singoli emocomponenti.
Le sacche che vengono lavorate in giornata devono essere mantenute alla temperatura di circa 20-25°C in modo da poter conservare il contenuto piastrinico che a temperature inferiori perderebbe le sue caratteristiche. Al contrario, le sacche che vengono lavorate il giorno successivo alla raccolta devono essere conservate in emoteca a 4°C; in questo modo non è possibile utilizzare le piastrine che, dopo la separazione, vengono eliminate.

Inizialmente le sacche vengono pesate e per procedere alla lavorazione, il peso deve rientrare in un range stabilito che per le sacche di sangue intero, deve essere compreso tra i 705 e i 799 grammi lordi corrispondente a 450 ml circa. Le sacche di plasmaferesi invece, devono aver un peso non inferiore ai 600grammi. Le sacche che non rientrano in questo intervallo vengono considerate non conformi, registrate ed eliminate.
In questa fase le sacche di sangue vengono poste in centrifughe per sacche e centrifugate per quindici minuti con una frequenza di 3800 giri alla temperatura ideale di conservazione degli emocomponenti.

Separatore automatico.
Separatore automatico.

In seguito alla centrifugazione il sangue intero viene scomposto, nella maggior parte dei casi grazie all’utilizzo di scompositori automatici in: concentrato eritrocitario, buffycoat e plasma che subiranno diversi processi di conservazione. Gli scompositori pesano i diversi emocomponenti contenuti in sacche satellite che, come nel caso della sacca satellite contenente il concentrato eritrocitario, possono contenere anche delle sostanze adittive.

Il plasma viene congelato, entro un’ora dalla separazione, in abbattitori che raggiungono la temperatura di circa -80 °C. Il plasma viene suddiviso in plasma di tipo A o plasmaferesi ad uso clinico da trasfondere quindi a pazienti, di tipo B se ottenuto dalla scomposizione di sangue intero entro le sei ore dal prelievo e di tipo C se ottenuto dalla scomposizione dopo le sei ore dal prelievo e privo di fattori di coagulazione. Nel caso del plasma di tipo B o C, questi vengono trasferiti all’industria che provvede alla produzione di farmaci come l’albumina.

Il concentrato eritrocitario viene posto in frigoemoteca a 4°C in attesa dei risultati dei test relativi alla qualificazione biologica e una volta effettuata la validazione viene etichettato e distribuito alle unità operative dove può essere conservato fino a 42 giorni dalla data di prelievo.

Il buffy coat viene conservato in agitatori piastrinici, a temperatura ambiente, per successiva lavorazione ed assemblaggio in pool piastrinici.
L’assemblaggio di concentrati piastrinici da pool di buffycoats avviene attraverso un sistema di connessione sterile che collega cinque buffy coats ad un kit che, etichettato con il codice univoco creato per il pool e posto in un apposito strumento dotato di centrifuga, permette di ottenere un pool piastrinico privo di plasma, globuli bianchi ed emazie, sospeso in una soluzione nutriente per le piastrine.

La conservazione degli emocomponenti ha tra gli obiettivi: la garanzia della sopravvivenza e della funzione di ciascun emocomponente, impedire che si realizzino modificazioni fisiche lesive sull’emocomponente e che si verifichi proliferazione batterica.
Le temperature e il tempo di conservazione degli emocomponenti sono indicati nella tabella di seguito riportata:

Prodotto

Temperatura di conservazione Periodo di validità

Emazie concentrate prive di B.C. in soluzione addittiva

4°C  +/-2° C

42 giorni

Sangue intero da autodonazione

4°C  +/-2° C

20 giorni

Plasma fresco congelato

<-25°C-18°C  -25°C

36 mesi

3 mesi

Crioprecipitato

<-25°C-18°C  -25°C

36 mesi

3 mesi

Concentrati piastrinici

22°C +/-2°C

5 giorni

Emazie lavate (con circuito aperto) 4°C  +/-2° C

24 ore

Per ogni sacca di sangue intero o da aferesi pervenuto in laboratorio viene effettuata la qualificazione biologica che consiste in test di immunoematologia eritrocitaria e test di screening di malattie infettive trasmissibili (epatite B, epatite C, AIDS, Lue). Dopo che le sacche vengono validate possono essere etichettate e distribuite alle unità operative.

Etichetta di sacca contenente emazie buffy-coat deplete.
Etichetta di sacca contenente emazie buffy-coat deplete.

L’etichetta presente su ogni sacca dovrà necessariamente riportare:

1 – nome e indirizzo della struttura di prelievo;
2- numero identificativo della donazione;
3- nome dell’emocomponente;
4 – volume o peso netto dell’emocomponente;
5 – gruppo ABO;
6 – Rh e fenotipo Rh;
7 – fenotipo Kell e eventuali altri fenotipi gruppo ematici se ricercati;
8 – elenco ed esito negativo dei controlli sierologici obbligatori;
9 – composizione e volume di eventuale soluzione addittiva;
10 – data e ora di donazione;
11 – data e ora di scadenza;
12 – temperatura di conservazione;
13 – eventuali lavorazioni: leucodeplezione, irradiazione, etc.

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