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Original Article

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Blood Res 2014; 49(4):

Published online December 31, 2014

https://doi.org/10.5045/br.2014.49.4.265

© The Korean Society of Hematology

Progress of in vitro factor VIII coagulant activity from 0 to 8 hours after reconstitution

Ye Jee Shim1, Kun Soo Lee2, Uk Hyun Kim3, Jin Kyung Suh4, Sae Yun Baik5, and Shin Young Hyun6*

Author Info. +

1Department of Pediatrics, Keimyung University Dongsan Medical Center, Keimyung University School of Medicine, Daegu, Korea.

2Department of Pediatrics, Kyungpook National University Hospital, Kyungpook National University School of Medicine, Daegu, Korea.

3Department of Pediatrics, Incheon Medical Center Beakryung Hospital, Incheon, Korea.

4Division of Pediatric Hematology/Oncology, Asan Medical Center Children's Hospital, Department of Pediatrics, University of Ulsan College of Medicine, Seoul, Korea.

5Green Cross Laboratories, Yongin, Korea.

6Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea.

Correspondence to : Correspondence to Shin Young Hyun, M.D. Department of Internal Medicine, Yonsei University Wonju College of Medicine, 20, Ilsan-ro, Wonju 220-701, Korea. Tel: +82-33-741-1204, Fax: +82-33-743-3308, drhyun@yonsei.ac.kr

Received: July 24, 2014; Revised: August 26, 2014; Accepted: November 12, 2014

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

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Background

Continuous infusion of factor VIII (FVIII) is a more cost-effective method for treating hemophilia A than intermittent bolus injection. However, there is currently no specific data in Korea about the progress of in vitro FVIII coagulant activity (FVIII:C) after reconstitution from its lyophilized form.

Methods

Three commercial FVIII concentrate products (two recombinant FVIII and one plasma-derived) were used. In vitro FVIII:C was measured at 0, 2, 4, 6, and 8 hours following reconstitution in both the indoor light-exposed and light-shielded groups.

Results

For the three drugs, in vitro FVIII:C decreased over the 8 hours following reconstitution (P<0.001). The decline of FVIII:C was linear (P<0.001). In vitro FVIII:C for the indoor light-exposed groups was 95.3±1.9% and 90.6±2.5% after 4 and 8 hours following reconstitution, respectively, compared to baseline activity. In the light-shielded group, FVIII:C was 95.4±1.1% and 90.9±1.7% of the baseline activity after 4 and 8 hours, respectively. There was no statistical difference between FVIII:C in the indoor light-exposed and light-shielded groups (P=0.849).

Conclusion

In vitro FVIII:C decreased after reconstitution, but activity was maintained at over 90% of the baseline value during 8 hours. Exposure to indoor light did not accelerate the loss of FVIII:C over the experimental time. This result indicates that CI with FVIII is available in 8-hour intervals, with no indoor light-exposure precautions needed.

Keywords Hemophilia A, Continuous infusion, Factor VIII

Article

Original Article

Blood Res 2014; 49(4): 265-269

Published online December 31, 2014 https://doi.org/10.5045/br.2014.49.4.265

Copyright © The Korean Society of Hematology.

Progress of in vitro factor VIII coagulant activity from 0 to 8 hours after reconstitution

Ye Jee Shim1, Kun Soo Lee2, Uk Hyun Kim3, Jin Kyung Suh4, Sae Yun Baik5, and Shin Young Hyun6*

1Department of Pediatrics, Keimyung University Dongsan Medical Center, Keimyung University School of Medicine, Daegu, Korea.

2Department of Pediatrics, Kyungpook National University Hospital, Kyungpook National University School of Medicine, Daegu, Korea.

3Department of Pediatrics, Incheon Medical Center Beakryung Hospital, Incheon, Korea.

4Division of Pediatric Hematology/Oncology, Asan Medical Center Children's Hospital, Department of Pediatrics, University of Ulsan College of Medicine, Seoul, Korea.

5Green Cross Laboratories, Yongin, Korea.

6Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Korea.

Correspondence to: Correspondence to Shin Young Hyun, M.D. Department of Internal Medicine, Yonsei University Wonju College of Medicine, 20, Ilsan-ro, Wonju 220-701, Korea. Tel: +82-33-741-1204, Fax: +82-33-743-3308, drhyun@yonsei.ac.kr

Received: July 24, 2014; Revised: August 26, 2014; Accepted: November 12, 2014

This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/3.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

Background

Continuous infusion of factor VIII (FVIII) is a more cost-effective method for treating hemophilia A than intermittent bolus injection. However, there is currently no specific data in Korea about the progress of in vitro FVIII coagulant activity (FVIII:C) after reconstitution from its lyophilized form.

Methods

Three commercial FVIII concentrate products (two recombinant FVIII and one plasma-derived) were used. In vitro FVIII:C was measured at 0, 2, 4, 6, and 8 hours following reconstitution in both the indoor light-exposed and light-shielded groups.

Results

For the three drugs, in vitro FVIII:C decreased over the 8 hours following reconstitution (P<0.001). The decline of FVIII:C was linear (P<0.001). In vitro FVIII:C for the indoor light-exposed groups was 95.3±1.9% and 90.6±2.5% after 4 and 8 hours following reconstitution, respectively, compared to baseline activity. In the light-shielded group, FVIII:C was 95.4±1.1% and 90.9±1.7% of the baseline activity after 4 and 8 hours, respectively. There was no statistical difference between FVIII:C in the indoor light-exposed and light-shielded groups (P=0.849).

Conclusion

In vitro FVIII:C decreased after reconstitution, but activity was maintained at over 90% of the baseline value during 8 hours. Exposure to indoor light did not accelerate the loss of FVIII:C over the experimental time. This result indicates that CI with FVIII is available in 8-hour intervals, with no indoor light-exposure precautions needed.

Keywords: Hemophilia A, Continuous infusion, Factor VIII

Fig 1.

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Figure 1.

The general outline of the experimental procedure is shown. Estimation of in vitro FVIII:Ca) was performed using three commercial products, divided into indoor light-exposed and light-shielded experimental groups. a)Factor VIII coagulant activity.

Blood Research 2014; 49: 265-269https://doi.org/10.5045/br.2014.49.4.265

Fig 2.

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Figure 2.

Comparison of in vitro FVIII:Ca) for each drug between the indoor light-exposed and light-shielded groups, during a period of 8 hours. The filled circles represent the FVIII:C in indoor light-exposed groups, while the empty rectangles represent the FVIII:C in light-shielded group. The values of P<0.0125 were considered as statistically significant on using the Bonferroni method. a)Factor VIII coagulant activity.

Blood Research 2014; 49: 265-269https://doi.org/10.5045/br.2014.49.4.265

Table 1 . In vitro FVIII:Ca) (%) after reconstitution according to the time..

a)Factor VIII coagulant activity..

b)P value by ANOVA between in vitro FVIII:C at 0, 2, 4, 6, and 8 hours in respective experimental conditions..
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