JP2018520103A - 全血の保存のための方法および全血の組成 - Google Patents
全血の保存のための方法および全血の組成 Download PDFInfo
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- JP2018520103A JP2018520103A JP2017560500A JP2017560500A JP2018520103A JP 2018520103 A JP2018520103 A JP 2018520103A JP 2017560500 A JP2017560500 A JP 2017560500A JP 2017560500 A JP2017560500 A JP 2017560500A JP 2018520103 A JP2018520103 A JP 2018520103A
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Abstract
Description
15個のpRBCユニットを健常なドナーから採取する。各ユニットを分割し、以下のように保存する:1つは、標準的な血液バンクの条件で保存し(対照)、他は、Yoshida et al.,“Anaerobic Storage of Red Blood Cells in a Novel Additive Solution Improves In vivo Recovery,”Transfusion 49:458−64(2008)に記載される方法に従って嫌気的に保存する(試験)。0、1、2、3、および6週目に、無菌接続デバイスを使用してPRBCユニットから試料を除去する。以下のアッセイのために血漿試料を凍結させる:Procarta Immunoassay Magnetic Beadキットを使用した22個のサイトカインに関する単一バッチ試験、質量分析アッセイによる8−イソプロスタンF2α、およびHemoCue血漿/光度計(HemoCue AB、Angelholm,Sweden)による無細胞ヘモグロビン。
ヘパリン管の回収を含む標準的なプロトコルに従って、1ユニットの血液をドナー患者からCPDA1またはCPDAのいずれかを含む抗凝固剤溶液中に採取する。最初の採血後4時間以内に、抗凝固剤を含有する採取した血液から製造業者の指示に従って白血球を除去する。ベースラインのABL90血液ガスおよび代謝パラメータは、標準的な手順に従ってドナーのヘパリン管および全血製剤から決定される。BSL Handbook Procedure BSL−P024:Procedure ManualおよびRadiometer ABL90 FLEX Gas Analyzer instructionsを参照されたい。
輸送バッグに入った酸素除去ならびに酸素および二酸化炭素除去血液を、メッシュに包み、ゴム紐で固定し、4つの吸収剤袋(Mitsubishi、SS−300)とともに嫌気性キャニスター内に入れる。キャニスターを密閉し、Alicat Gas Processing Systemを使用してキャニスターから空気を追放する。BSL Handbook Procedure BSL−P040:Procedure for Placing Blood Products in Anaerobic Storage in Canistersを参照されたい。嫌気性および好気性の血液を1〜6℃の血液バンクの冷蔵庫内に入れる。キャニスターのゲージを毎日監視して、それらが5±1psiを表示することを確認する。2psi未満のキャニスターは、標準的な手順に調整される。BSL Handbook Procedure BSL−P040:Procedure for Placing Blood Products in Anaerobic Storage in Canistersを参照されたい。
指定された時点で試料を試験する:処理後0日目(T0)、1日目、1週間目、2週間目、および3週間目。試料は、所与の試験の必要に応じて、新鮮な状態で、または後の試験のために凍結した状態で試験されてもよい。試験は、全血球数(CBC)、トロンボエラストグラフィ(TEG)を含む。
ATPの測定のために、脱タンパク質および沈殿により試料を処理する。1mlの試料(例えば、LRWB/CPDもしくはLRWB/CPDA−1または前述の試料)を、1.0mlの氷冷トリクロロ酢酸(TCA)(12%w/v)で沈殿させ、15〜30秒間ボルテックスし、氷上で5分間インキュベートする。TCA/試料混合物を含む試験管を4℃で5分間、3600gで遠心分離する。TCAへの曝露を最小限に抑えるために、試料を直ちに処理する。清澄な上清を予め冷却しておいた試験管に移し、ドライアイスアルコール浴で瞬間凍結させ、−70℃で保存する。
9ユニットの個々の全血を、標準的な500mLの献血を通じて、同意を得た健常なボランティアから得る。献血された全血を、標準的なAABB/FDAガイドラインに従って白血球除去赤血球(LR−RBC)ユニットに処理し、得られたユニットを次いで2等分する。ユニットの一方の半分は、実施例2および3に記載されるようにO2およびCO2を除去する。
表1:酸素除去保存後の血液細胞の灌流速度
8ユニットの全血(WB)を、標準的な500mLの献血を通じて、同意を得た健常なボランティアから得る。献血された全血を、実施例2に記載されるようにCPDA−1抗凝固剤中に採取し(Research Blood Components,Inc.)、血小板保存フィルタ(Imuflex(登録商標)WB−SP)(LRWB;Terumo Medical Corporation)を用いて白血球を除去する。その結果得られた濾過済みのユニットを、次いで2等分する。ユニットの一方の半分は、従来通りに好気的に低温保存し、第2の半分は、さらに分割して嫌気的に低温保存する。嫌気的に保存されたユニットから、酸素を除去するか(OR−LRWB)または酸素および二酸化炭素除去を除去する(OCR−LRWB)。嫌気的に保存されたユニットを、Sorin D100膜型人工肺を用いて処理し、約5%のSO2および約35mmHgpCO2を含む嫌気性ユニットを得る。その結果得られた嫌気性ユニットを標準的なPVCバッグに入れ、酸素吸収剤および窒素ガスを含む嫌気性キャニスター内に保存する。一対の白血球除去血小板ユニットを、下記のように21日の保存期間全体を通して毎週評価する。
Claims (88)
- 頻回輸血を必要とする患者の生存を改善するための方法であって、酸素を除去した保存赤血球(OR保存RBC)を、それを必要とする、医療処置を受ける患者に提供することを含む、方法。
- 前記OR保存RBCは、酸素および二酸化炭素が除去されている(OCR−保存RBC)、請求項1に記載の方法。
- 前記OR保存RBCは、従来通りに保存された赤血球(保存RBC)と比較して低レベルの未結合RANTES因子を含む、請求項1または請求項2に記載の方法。
- 前記RANTESのレベルは、21日後には500pg/ml未満である、請求項1〜3のいずれか一項に記載の方法。
- 前記RANTESのレベルは、脱酸素化条件下で21日保存した後には300pg/ml未満である、請求項1〜4のいずれか一項に記載の方法。
- 前記OR保存RBCは、従来通りに保存された赤血球(保存RBC)と比較して低レベルのエオタキシン因子を含む、請求項1〜5のいずれか一項に記載の方法。
- 前記エオタキシンのレベルは、脱酸素化条件下で21日保存した後には150pg/ml未満である、請求項1〜6のいずれか一項に記載の方法。
- 前記エオタキシンのレベルは、脱酸素化条件下で21日保存した後には100pg/ml未満である、請求項1〜7のいずれか一項に記載の方法。
- 前記OR保存RBCは、酸素除去‐白血球除去全血(OR−LRWB)、血小板を含む酸素除去‐白血球除去全血(OR−LRWB+PLT)、酸素除去‐白血球除去濃厚赤血球(OR−LRpRBC)、血小板を含む酸素除去‐白血球除去濃厚赤血球(OR−LRpRBC+PLT)、酸素および二酸化炭素除去‐白血球除去全血(OCR−LRWB)、血小板を含む酸素および二酸化炭素除去‐白血球除去全血(OCR−LRWB+PLT)、酸素および二酸化炭素除去‐白血球除去濃厚赤血球(OCR−LRpRBC)、血小板を含む酸素および二酸化炭素除去‐白血球除去濃厚赤血球(OCR−LRpRBC+PLT)、ならびにそれらの組み合わせからなる群から選択される、請求項1〜8のいずれか一項に記載の方法。
- 前記OR保存RBCは、酸素除去‐白血球除去全血(OR−LRWB)、血小板を含む酸素除去‐白血球除去全血(OR−LRWB+PLT)、酸素および二酸化炭素除去‐白血球除去全血(OCR−LRWB)、または血小板を含む酸素および二酸化炭素除去‐白血球除去全血(OCR−LRWB+PLT)を含む、請求項1〜9のいずれか一項に記載の方法。
- 前記頻回輸血を必要とする患者は、外傷患者、移植患者、心臓手術患者、産科患者、GI手術患者、または整形外科手術患者である、請求項1〜10のいずれか一項に記載の方法。
- 前記外傷患者は、出血性外傷患者または鈍的外傷患者である、請求項1〜11のいずれか一項に記載の方法。
- 前記患者は、癌患者であり、前記OR保存RBCは、酸素除去‐白血球除去濃厚赤血球(OR−LRpRBC)、血小板を含む酸素除去‐白血球除去濃厚赤血球(OR−LRpRBC+PLT)、酸素および二酸化炭素除去‐白血球除去濃厚赤血球(OCR−LRpRBC)、または血小板を含む酸素および二酸化炭素除去‐白血球除去濃厚赤血球(OCR−LRpRBC+PLT)である、請求項1〜12のいずれか一項に記載の方法。
- 周術期の輸血後に、それを必要とする癌患者の生存を改善するための方法であって、酸素除去保存赤血球(OR保存RBC)を、それを必要とする、外科的処置を受ける癌患者に提供することを含む、方法。
- 前記OR保存RBCは、酸素および二酸化炭素除去赤血球(OCR−保存RBC)である、請求項14に記載の方法。
- 前記OR保存RBCは、酸素除去‐白血球除去濃厚赤血球(OR−LRpRBC)、血小板を含む酸素除去‐白血球除去濃厚赤血球(OR−LRpRBC+PLT)、酸素および二酸化炭素除去‐白血球除去濃厚赤血球(OCR−LRpRBC)、または血小板を含む酸素および二酸化炭素除去‐白血球除去濃厚赤血球(OCR−LRpRBC+PLT)である、請求項14または請求項15に記載の方法。
- 前記OR保存RBCは、非酸素除去保存赤血球(保存RBC)と比較して低レベルのRANTESまたはエオタキシン因子を含む、請求項14〜16のいずれか一項に記載の方法。
- 前記RANTESのレベルは、21日後には500pg/ml未満であるか、前記エオタキシンのレベルは、脱酸素化条件下で21日保存した後には150pg/ml未満である、請求項14〜17のいずれか一項に記載の方法。
- 保存血液中のサイトカインを減少させるための方法であって、
抗凝固剤溶液中に血液を採取することと、
前記採取した血液から白血球を除去することと、
保存前の酸素飽和度(SO2)を30%未満に低下させることと、
前記採取した酸素除去血液を嫌気性条件下で保存して酸素除去保存血液を調製することと、を含む、方法。 - 血小板を含む酸素除去濃厚赤血球(OR−pRBC+PLT)を調製するために、血漿を除去することおよび添加液を加えることをさらに含む、請求項19に記載の方法。
- 前記白血球の前記除去は、血小板を除去することをさらに含む、求項19に記載の方法。
- 酸素除去濃厚赤血球(OR−pRBC)を調製するために、血漿を除去することおよび添加液を加えることをさらに含む、請求項21に記載の方法。
- 1つ以上のサイトカインのレベルが、非酸素除去保存赤血球(保存RBC)と比較して低い、請求項19〜22のいずれか一項に記載の方法。
- 前記サイトカインは、単球走化性タンパク質−1(MCP−1)、活性化時調節正常T細胞発現および分泌物(RANTES)、アンジオゲニン、腫瘍壊死因子α(TNF−α)、上皮増殖因子(EGF)、可溶性CD40リガンド(sCD40L)、ならびに血小板由来増殖因子(PDGF)からなる群から選択される、請求項19〜23のいずれか一項に記載の方法。
- 前記保存前の酸素飽和度を低下させることは、保存前の二酸化炭素分圧を60mmHg未満に低下させることをさらに含む、請求項19に記載の方法。
- 血小板を含む炭素および二酸化炭素除去濃厚赤血球(OCR−pRBC+PLT)を調製するために、血漿を除去することおよび添加液を加えることをさらに含む、請求項25に記載の方法。
- 前記白血球の前記除去は、血小板を除去することをさらに含む、請求項25に記載の方法。
- 酸素除去濃厚赤血球(OR−pRBC)を調製するために、血漿を除去することおよび添加液を加えることをさらに含む、請求項27に記載の方法。
- 前記酸素除去保存血液は、非酸素除去保存赤血球(保存RBC)と比較して低レベルのRANTES因子を含む、請求項19または25〜28のいずれか一項に記載の方法。
- 前記酸素除去保存血液は、非酸素除去保存赤血球(保存RBC)と比較して低レベルのエオタキシン因子を含む、請求項19または25〜29のいずれか一項に記載の方法。
- 前記酸素除去保存血液は、改善されたレベルの2,3−DPGを有し、前記酸素除去‐白血球除去血液は、15日目に、白血球除去血液の初期2,3−DPGレベルよりも高い2,3−DPGレベルを有する、請求項19に記載の方法。
- 前記2,3−DPGレベルは、0日目の血液の2,3−DPGレベルよりも少なくとも80%またはそれ以上高い、請求項19また請求項31に記載の方法。
- 前記2,3−DPGレベルは、21日目に5〜20μmol 2,3−DPG/gHbである、請求項19、31〜32のいずれか一項に記載の方法。
- 前記酸素除去保存血液は、酸素除去‐白血球除去全血(OR−LRWB)、血小板を含む酸素除去‐白血球除去全血(OR−LRWB+PLT)、酸素除去‐白血球除去濃厚赤血球(OR−LRpRBC)、血小板を含む酸素除去‐白血球除去濃厚赤血球(OR−LRpRBC+PLT)、酸素および二酸化炭素除去‐白血球除去全血(OCR−LRWB)、血小板を含む酸素および二酸化炭素除去‐白血球除去全血(OCR−LRWB+PLT)、酸素および二酸化炭素除去‐白血球除去濃厚赤血球(OCR−LRpRBC)、血小板を含む酸素および二酸化炭素除去‐白血球除去濃厚赤血球(OCR−LRpRBC+PLT)、ならびにそれらの組み合わせからなる群から選択される、請求項19〜33のいずれか一項に記載の方法。
- 抗凝固剤溶液中に酸素除去‐白血球除去全血(OR−LRWB)を含み、30%未満の保存前および保存中の酸素飽和度(SO2)を有し、15日目に、前記酸素除去‐白血球除去全血の初期2,3−DPGレベルよりも高い2,3−DPGレベルを有するか、または、30%未満の保存前および保存中の酸素飽和度(SO2)ならびに60mmHg未満の保存前および保存中の二酸化炭素分圧を有する酸素および二酸化炭素‐白血球除去全血(OCR−LRWB)を含み、前記OCR−LRWBは、少なくとも3μmol/gHbのアデノシン三リン酸(ATP)レベルを有する、それを必要とする外傷患者への輸血のための血液組成。
- 前記OR−LRWBの前記2,3−DPGレベルは、0日目の血液の2,3−DPGレベルよりも少なくとも80%またはそれ以上高い、請求項35に記載の血液組成。
- 前記OR−LRWBの前記2,3−DPGレベルは、少なくとも5〜20DPG μmol/gHbである、請求項35または請求項36に記載の血液組成。
- 前記保存前の酸素飽和度は、20%未満、10%未満、または5%未満である、請求項35〜37のいずれか一項に記載の血液組成。
- 前記保存前の分圧は、1〜60mmHg、10〜60mmHg、20〜40mmHg、1〜20mmHgである、請求項35〜38のいずれか一項に記載の血液組成。
- 前記抗凝固剤溶液は、クエン酸リン酸デキストロースアデニン(CPDA1)またはクエン酸リン酸デキストロース(CPD)である、請求項35〜39のいずれか一項に記載の血液組成。
- 前記酸素除去‐白血球除去全血(OR−LRWB)または酸素および二酸化炭素‐白血球除去全血(OCR−LRWB)は、サイトカイン、ケモカイン、イソプロスタン、および酸化脂質産物からなる群から選択される、低レベルの生物学的応答調節物質(BRM)を有する、請求項35〜40のいずれか一項に記載の血液組成。
- 前記酸素除去‐白血球除去全血(OR−LRWB)または酸素および二酸化炭素‐白血球除去全血(OCR−LRWB)を輸血される患者は、炎症反応の低下を示す、請求項41に記載の血液組成。
- 前記酸素除去‐白血球除去全血(OR−LRWB)または酸素および二酸化炭素‐白血球除去全血(OCR−LRWB)を輸血される患者は、免疫修飾作用の低下を示す、請求項41または請求項42に記載の血液組成。
- 前記酸素除去‐白血球除去全血(OR−LRWB)または酸素および二酸化炭素‐白血球除去全血(OCR−LRWB)を輸血される患者は、多臓器機能障害のリスクが低下する、請求項41〜43のいずれか一項に記載の血液組成。
- 前記酸素除去‐白血球除去全血(OR−LRWB)または酸素および二酸化炭素‐白血球除去全血(OCR−LRWB)を輸血される患者は、敗血症のリスクが低下する、請求項41〜44のいずれか一項に記載の血液組成。
- 前記酸素除去‐白血球除去全血(OR−LRWB)または酸素および二酸化炭素‐白血球除去全血(OCR−LRWB)を輸血される患者は、感染のリスクが低下する、請求項41〜45のいずれか一項に記載の血液組成。
- 前記酸素除去‐白血球除去全血(OR−LRWB)または酸素および二酸化炭素‐白血球除去全血(OCR−LRWB)を輸血される患者は、死亡リスクが低下する、請求項41〜46のいずれか一項に記載の血液組成。
- 前記酸素除去‐白血球除去全血(OR−LRWB)または酸素および二酸化炭素‐白血球除去全血(OCR−LRWB)を輸血される患者は、より高い赤血球(RBC)変形能を有する、請求項41〜47のいずれか一項に記載の血液組成。
- 前記血液は、非酸素除去‐白血球除去全血(OR−LRWB)または非酸素および二酸化炭素‐白血球除去全血(OCR−LRWB)と比較した場合に、トロンボエラストグラフィ(TEG)によって測定される同等のまたはより良好な凝固パラメータを有する、請求項41〜48のいずれか一項に記載の血液組成。
- 前記血液は、非酸素除去‐白血球除去全血(OR−LRWB)または非酸素および二酸化炭素‐白血球除去全血(OCR−LRWB)と比較した場合に、PT/PTT、フィブリノゲン、Dダイマー、およびトロンビン生成試験によって決定される同等のまたはより良好な凝固パラメータを有する、請求項41〜49のいずれか一項に記載の血液組成。
- 前記血液は、非酸素除去‐白血球除去全血(OR−LRWB)または非酸素および二酸化炭素‐白血球除去全血(OCR−LRWB)と比較した場合に、血小板凝集計によって測定される同等のまたはより良好な血小板機能パラメータを有する、請求項41〜50のいずれか一項に記載の血液組成。
- 前記血液は、非酸素除去‐白血球除去全血(OR−LRWB)または非酸素および二酸化炭素‐白血球除去全血(OCR−LRWB)と比較した場合に、第V因子、第VIII因子、AT、プロテインC、またはvWFを含む同等のまたはより良好なレベルの凝固因子を有する、請求項41〜51のいずれか一項に記載の血液組成。
- 前記血液は、それを必要としている患者への輸血に少なくとも3週間安全である、請求項41〜52のいずれか一項に記載の血液組成。
- 輸血を受ける患者における炎症反応を低下させる方法であって、酸素除去血液製剤を、それを必要とする患者に輸血することを含み、前記酸素除去血液製剤は、嫌気性条件下での保存後に低レベルの炎症性サイトカインを有する、方法。
- 前記低レベルの炎症性サイトカインは、非酸素除去保存赤血球と比較して低レベルのサイトカイン、エオタキシンまたはRANTESである、請求項54に記載の方法。
- 前記血液製剤は、酸素除去‐白血球除去全血(OR−LRWB)、血小板を含む酸素除去‐白血球除去全血(OR−LRWB+PLT)、酸素除去‐白血球除去濃厚赤血球(OR−LRpRBC)、血小板を含む酸素除去‐白血球除去濃厚赤血球(OR−LRpRBC+PLT)、酸素および二酸化炭素除去‐白血球除去全血(OCR−LRWB)、血小板を含む酸素および二酸化炭素除去‐白血球除去全血(OCR−LRWB+PLT)、酸素および二酸化炭素除去‐白血球除去濃厚赤血球(OCR−LRpRBC)、血小板を含む酸素および二酸化炭素除去‐白血球除去濃厚赤血球(OCR−LRpRBC+PLT)、血漿、ならびにそれらの組み合わせからなる群から選択される、請求項54または請求項55に記載の方法。
- 輸血を受ける患者における免疫修飾作用を低下させる方法であって、酸素除去血液製剤を、それを必要とする患者に輸血することを含み、前記酸素除去血液製剤は、嫌気性条件下での保存後に低レベルのサイトカインを有し、前記サイトカインのレベルは、非酸素除去血液製剤と比較される、方法。
- 前記サイトカインは、単球走化性タンパク質−1(MCP−1)、活性化時調節正常T細胞発現および分泌物(RANTES)、アンジオゲニン、腫瘍壊死因子α(TNF−α)、上皮増殖因子(EGF)、可溶性CD40リガンド(sCD40L)、ならびに血小板由来増殖因子(PDGF)からなる群から選択される、請求項57に記載の方法。
- 前記サイトカインは、エオタキシンまたはRANTESである、請求項57または請求項58に記載の方法。
- 前記血液製剤は、酸素除去‐白血球除去全血(OR−LRWB)、血小板を含む酸素除去‐白血球除去全血(OR−LRWB+PLT)、酸素除去‐白血球除去濃厚赤血球(OR−LRpRBC)、血小板を含む酸素除去‐白血球除去濃厚赤血球(OR−LRpRBC+PLT)、酸素および二酸化炭素除去‐白血球除去全血(OCR−LRWB)、血小板を含む酸素および二酸化炭素除去‐白血球除去全血(OCR−LRWB+PLT)、酸素および二酸化炭素除去‐白血球除去濃厚赤血球(OCR−LRpRBC)、血小板を含む酸素および二酸化炭素除去‐白血球除去濃厚赤血球(OCR−LRpRBC+PLT)、血漿、血小板濃縮物、ならびにそれらの組み合わせからなる群から選択される、請求項57〜59のいずれか一項に記載の方法。
- それを必要とする患者における酸素の灌流を改善するための方法であって、酸素除去血液製剤を、それを必要とする患者に輸血することを含み、前記酸素除去血液製剤は、従来通りに保存された血液製剤と比較してより高いRBC変形能を有する、方法。
- 前記酸素除去血液製剤は、酸素除去‐白血球除去全血(OR−LRWB)、血小板を含む酸素除去‐白血球除去全血(OR−LRWB+PLT)、酸素除去‐白血球除去濃厚赤血球(OR−LRpRBC)、血小板を含む酸素除去‐白血球除去濃厚赤血球(OR−LRpRBC+PLT)、酸素および二酸化炭素除去‐白血球除去全血(OCR−LRWB)、血小板を含む酸素および二酸化炭素除去‐白血球除去全血(OCR−LRWB+PLT)、酸素および二酸化炭素除去‐白血球除去濃厚赤血球(OCR−LRpRBC)、血小板を含む酸素および二酸化炭素除去‐白血球除去濃厚赤血球(OCR−LRpRBC+PLT)、血漿、血小板濃縮物、ならびにそれらの組み合わせからなる群から選択される、請求項61に記載の方法。
- 前記酸素除去血液製剤は、少なくとも1週間の保存後に、酸素除去‐白血球除去全血(OR−LRWB)、血小板を含む酸素除去‐白血球除去全血(OR−LRWB+PLT)、酸素および二酸化炭素除去‐白血球除去全血(OCR−LRWB)、または血小板を含む酸素および二酸化炭素除去‐白血球除去全血(OCR−LRWB+PLT)から、成分分離、血漿の除去、および添加液の添加によって得られた、酸素除去‐白血球除去濃厚赤血球(OR−LRpRBC)、血小板を含む酸素除去‐白血球除去濃厚赤血球(OR−LRpRBC+PLT)、酸素および二酸化炭素除去‐白血球除去濃厚赤血球(OCR−LRpRBC)、または血小板を含む酸素および二酸化炭素除去‐白血球除去濃厚赤血球(OCR−LRpRBC+PLT)を含む、回収された血液製剤である、請求項61または請求項62に記載の方法。
- 前記回収された血液製剤は、最長42日間、最長56日間、または最長64日間保存される、請求項61〜63のいずれか一項に記載の方法。
- 血液バンクを管理するための方法であって、
酸素除去全血および抗凝固剤、または酸素除去‐白血球除去全血および抗凝固剤を含む血液ユニットの在庫を維持することと、
患者の治療のために、前記在庫から前記血液ユニットのうちの1つ以上を提供することと、
前記在庫からの血液ユニットを再利用して、成分を分離した酸素除去血液ユニットを調製することと、を含む、方法。 - 前記成分を分離した酸素除去血液ユニットは、血小板を含む酸素除去‐白血球除去濃厚赤血球(OR−LRpRBC+PLT)、血小板を含む酸素および二酸化炭素除去‐白血球除去濃厚赤血球(OCR−LRpRBC+PLT)、酸素除去血漿、またはそれらの組み合わせを含む、請求項65に記載の方法。
- 前記成分を分離した酸素除去血液ユニットを再利用して大量輸血キットを調製する、請求項65または請求項66に記載の方法。
- 前記抗凝固剤は、クエン酸リン酸デキストロース(CPD)またはクエン酸リン酸デキストロースアデニン(CPDA−1)を含む、請求項65〜67のいずれか一項に記載の方法。
- 前記血液ユニットの再利用は、CPD含有血液ユニットの場合は保存の3週間前に、またはCPDA1含有血液ユニットの場合は保存の5週間前に行われる、請求項65〜68のいずれか一項に記載の方法。
- 前記血液ユニットの再利用は、2週間で行われる、請求項65〜69のいずれか一項に記載の方法。
- 前記血液ユニットの再利用は、嫌気性条件下で行われる、請求項65〜70のいずれか一項に記載の方法。
- 前記成分を分離した酸素除去血液ユニットは、添加液の添加後、最長6週間保存される、請求項65〜71のいずれか一項に記載の方法。
- ある体積の血漿およびある体積の血小板を含む白血球除去濃厚赤血球(LRpRBC+PLT)を含む大量輸血キットを調製することをさらに含む、請求項65〜72のいずれか一項に記載の方法。
- 血漿対LRpRBC+PLTの体積比は、1:1である、請求項73に記載の方法。
- 血漿対LRpRBC+PLTの体積比は、1:2である、請求項73または請求項74に記載の方法。
- 前記大量輸血キットは、ある体積の血小板をさらに含み、血漿、血小板、およびLRpRBC+PLTの体積比は、1:1:1である、請求項73に記載の方法。
- 前記大量輸血キットは、ある体積の血小板をさらに含み、血漿、血小板、およびLRpRBC+PLTの体積比は、1:1:2である、請求項73または請求項76に記載の方法。
- 輸血医療のために血液製剤の供給を行う方法であって、
全血から酸素もしくは酸素および二酸化炭素を枯渇させて酸素除去全血(または酸素および二酸化炭素除去全血)を調製すること、ならびに
前記酸素もしくは酸素および二酸化炭素除去全血をある期間保存し、前記保存血液を、それを必要とする患者に提供すること、または
前記酸素もしくは酸素および二酸化炭素除去全血をある期間保存し、酸素もしくは酸素および二酸化炭素除去濃厚赤血球を調製すること、を含む、方法。 - 前記酸素または酸素および二酸化炭素除去濃厚赤血球は、第2の期間保存され、次いで、それを必要とする患者に提供される、請求項78に記載の方法。
- 前記第2の期間は、最長6週間である、請求項78または請求項79に記載の方法。
- 酸素除去濃厚赤血球および血小板を含み、1×105/L未満の白血球を有する、血液組成。
- 前記組成は、1×104/L未満の白血球を含む、請求項81に記載の血液組成。
- AS−1、AS−3(Nutricel(登録商標))、AS−5、SAGM、PAGG−SM、PAGG−GM、MAP、AS−7、ESOL−5、EAS61、OFAS1、OFAS3、およびそれらの組み合わせからなる群から選択される添加液をさらに含む、請求項81または請求項82に記載の血液組成。
- ある体積の血漿およびある体積のLRpRBC+PLTを含む、大量輸血キット。
- 血漿対LRpRBC+PLTの体積比は、1:1である、請求項84に記載の大量輸血キット。
- 血漿対LRpRBC+PLTの体積比は、1:2である、請求項84または請求項85に記載の大量輸血キット。
- ある体積の血小板をさらに含み、血漿、血小板、およびLRpRBC+PLTの体積比は、1:1:1である、請求項84に記載の大量輸血キット。
- ある体積の血小板をさらに含み、血漿、血小板、およびLRpRBC+PLTの体積比は、1:1:1である、請求項84または請求項87に記載の大量輸血キット。
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BR112017024091B1 (pt) | 2022-09-20 |
BR112017024091A2 (pt) | 2018-07-24 |
JP2022126634A (ja) | 2022-08-30 |
IL289099A (en) | 2022-02-01 |
US20210260126A1 (en) | 2021-08-26 |
EP3297641A4 (en) | 2019-02-06 |
MX2022008266A (es) | 2022-08-04 |
EP3297641A1 (en) | 2018-03-28 |
JP7487258B2 (ja) | 2024-05-20 |
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MX2017014812A (es) | 2018-05-11 |
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BR122021024410B1 (pt) | 2022-05-03 |
AU2016264327B2 (en) | 2021-12-23 |
MX2022008272A (es) | 2022-08-04 |
AU2021286427A1 (en) | 2022-01-20 |
US20180133255A1 (en) | 2018-05-17 |
US11013771B2 (en) | 2021-05-25 |
IL255691B (en) | 2022-01-01 |
JP7075215B2 (ja) | 2022-05-25 |
CN107735095A (zh) | 2018-02-23 |
CA2985799A1 (en) | 2016-11-24 |
AU2016264327A1 (en) | 2017-12-07 |
IL289099B1 (en) | 2023-12-01 |
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CO2017012866A2 (es) | 2018-03-28 |
IL289099B2 (en) | 2024-04-01 |
CN114748503A (zh) | 2022-07-15 |
US20230028174A1 (en) | 2023-01-26 |
IL255691A (en) | 2018-01-31 |
CN107735095B (zh) | 2022-06-14 |
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