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In vitro evaluation of residual procoagulants in human intravenous immunoglobulins from 11 Chinese blood fractionation companies.
Thromb Res. 2013 Sep; 132(3):381-5.TR

Abstract

INTRODUCTION

Residual procoagulants has been suggested to play an important role in the occurrence of thromboembolic events with intravenous immunoglobulin.

OBJECTIVE

This study investigated the predominant plasma proteases in 81 intravenous immunoglobulin lots from 11 Chinese manufacturers to examine the procoagulants of these human therapeutic intravenous immunoglobulin products.

METHODS

In one-stage clotting assays, the procoagulant activities of factors II, VII, IX, X, XI, and XII were quantified. Non-activated partial thromboplastin time and a modified thrombin generation test served as global and activated coagulation factor XI specific clotting assays, respectively.

RESULTS

The coagulation factor clotting activities of the 78 intravenous immunoglobulin lots were below the detection limit of the assays. The time to peak of thrombin generation using a thrombin generation test was longer than 35min. The relevant amount of activated coagulation factor XI was below 0.37 nM. Non-activated partial thromboplastin time was greater than 203s, except for the three pilot samples of manufacturer B in which we observed 0.48 to 0.09IU/mL factor XI lever, 20 to 26min for the time to peak of thrombin generation, 0.54 to 37.99 nM activated coagulation factor XI, and 155 to 182s for non-activated partial thromboplastin time.

CONCLUSIONS

The three intravenous immunoglobulin lots from manufacturer B showed significant procoagulant potential. Further study is required to determine whether a program for activated coagulation factor XI determination in intravenous immunoglobulin products should be launched in China.

Authors+Show Affiliations

Institute of Blood Transfusion, Chinese Academy of Medical Sciences, Chengdu, Sichuan, China.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23953595

Citation

Ma, Li, et al. "In Vitro Evaluation of Residual Procoagulants in Human Intravenous Immunoglobulins From 11 Chinese Blood Fractionation Companies." Thrombosis Research, vol. 132, no. 3, 2013, pp. 381-5.
Ma L, Sun P, Lin F, et al. In vitro evaluation of residual procoagulants in human intravenous immunoglobulins from 11 Chinese blood fractionation companies. Thromb Res. 2013;132(3):381-5.
Ma, L., Sun, P., Lin, F., Diao, G., & Li, C. (2013). In vitro evaluation of residual procoagulants in human intravenous immunoglobulins from 11 Chinese blood fractionation companies. Thrombosis Research, 132(3), 381-5. https://doi.org/10.1016/j.thromres.2013.07.020
Ma L, et al. In Vitro Evaluation of Residual Procoagulants in Human Intravenous Immunoglobulins From 11 Chinese Blood Fractionation Companies. Thromb Res. 2013;132(3):381-5. PubMed PMID: 23953595.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - In vitro evaluation of residual procoagulants in human intravenous immunoglobulins from 11 Chinese blood fractionation companies. AU - Ma,Li, AU - Sun,Pan, AU - Lin,Fangzhao, AU - Diao,Ge, AU - Li,Changqing, Y1 - 2013/07/31/ PY - 2013/05/07/received PY - 2013/07/04/revised PY - 2013/07/25/accepted PY - 2013/8/20/entrez PY - 2013/8/21/pubmed PY - 2014/6/15/medline KW - Activated coagulation factor XI KW - FII KW - FIX KW - FVII KW - FX KW - FXI KW - FXII KW - FXIa KW - IVIG KW - Intravenous immunoglobulin KW - NAPTT KW - Procoagulant KW - TEEs KW - TGT KW - TTP KW - Thromboembolic events KW - activated coagulation factor XI KW - factor II KW - factor IX KW - factor VII KW - factor X KW - factor XI KW - factor XII KW - intravenous immunoglobulin KW - non-activated partial thromboplastin time KW - the time to peak of thrombin generation KW - thrombin generation test SP - 381 EP - 5 JF - Thrombosis research JO - Thromb Res VL - 132 IS - 3 N2 - INTRODUCTION: Residual procoagulants has been suggested to play an important role in the occurrence of thromboembolic events with intravenous immunoglobulin. OBJECTIVE: This study investigated the predominant plasma proteases in 81 intravenous immunoglobulin lots from 11 Chinese manufacturers to examine the procoagulants of these human therapeutic intravenous immunoglobulin products. METHODS: In one-stage clotting assays, the procoagulant activities of factors II, VII, IX, X, XI, and XII were quantified. Non-activated partial thromboplastin time and a modified thrombin generation test served as global and activated coagulation factor XI specific clotting assays, respectively. RESULTS: The coagulation factor clotting activities of the 78 intravenous immunoglobulin lots were below the detection limit of the assays. The time to peak of thrombin generation using a thrombin generation test was longer than 35min. The relevant amount of activated coagulation factor XI was below 0.37 nM. Non-activated partial thromboplastin time was greater than 203s, except for the three pilot samples of manufacturer B in which we observed 0.48 to 0.09IU/mL factor XI lever, 20 to 26min for the time to peak of thrombin generation, 0.54 to 37.99 nM activated coagulation factor XI, and 155 to 182s for non-activated partial thromboplastin time. CONCLUSIONS: The three intravenous immunoglobulin lots from manufacturer B showed significant procoagulant potential. Further study is required to determine whether a program for activated coagulation factor XI determination in intravenous immunoglobulin products should be launched in China. SN - 1879-2472 UR - https://www.unboundmedicine.com/medline/citation/23953595/In_vitro_evaluation_of_residual_procoagulants_in_human_intravenous_immunoglobulins_from_11_Chinese_blood_fractionation_companies_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0049-3848(13)00319-8 DB - PRIME DP - Unbound Medicine ER -