Thromboplastin Calibration and Oral Anticoagulant Control

265 Pages·1984·12.962 MB·English

by  A. M. H. P. van den Besselaar PhD, H. R. Gralnick MD, S. M. Lewis MD (auth.)

THROMBOPLASTIN CALI BRA nON AND ORAL ANTICOAGULANT
CONTROL
Compliments of
American Dade Educations
DEVELOPMENTS IN HEMATOLOGY AND IMMUNOLOGY
Other titles in this series:
Lijnen, H.R., Collen, D. and Verstraete, M., eds: Synthetic Substrates in Clinical Blood
Coagulation Assays. 1980. ISBN 90-247-2409-0
Smit Sibinga, C.Th., Das, P.e. and Forfar, 1.0., eds: Paediatrics and Blood Transfusion.
1982. ISBN 90-247-2619-0
Fabris, N., ed: Immunology and Ageing. 1982. ISBN 90-247-2640-9
Homstra, G.: Dietary Fats, Prostanoids and Arterial Thrombosis. 1982.
ISBN 90-247-2667-0
Smit Sibinga, C.Th., Das, P.e. and Loghem, van 1.1., eds: Blood Transfusion and Prob
lems of Bleeding. 1982. ISBN 90-247-3058-9
Dormandy, 1., ed: Red Cell Deformability and Filterability. 1983. ISBN 0-89838-578-4
Smit Sibinga, e.Th., Das, P .C. and Taswell, H.F., eds: Quality Assurance in Blood Bank
ing and Its Clinical Impact. 1984. ISBN 0-89838-618-7
Thromboplastin Calibration and Oral
Anticoagulant Control'
edited by
A.M.H.P. van den BESSELAAR, PhD
Reference Laboratory for Anticoagulant Control, Leiden University Hospital,
Leiden, The Netherlands
H.R. GRALNICK, MD
Hematology Service, Clinical Center, National Institutes of Health,
Bethesda, Maryland, USA
S.M. LEWIS, MD
Department of Hematology, Royal Postgraduate Medical School,
Hammersmith Hospital, London, UK
1984 MARTINUS NIJHOFF PUBLISHERS
a member of the KLUWER ACADEMIC PUBLISHERS GROUP
BOSTON / THE HAGUE / DORDRECHT / LANCASTER
This publication is based upon a Boerhaave course, organized by the Faculty of
Medicine, University of Leiden.
Distributors
for the United States and Canada: Kluwer Academic Publishers, 190 Old Derby
Street, Hingham, MA 02043, USA
for the UK and Ireland: Kluwer Academic Publishers, MTP Press Limited,
Falcon House, Queen Square, Lancaster LAl 1R N, UK
for all other countries: Kluwer Academic Publishers Group, Distribution Center,
P.O. Box 322, 3300 AH Dordrecht, The Netherlands
Library of Congress Card Number: 84-1559
lSBN-13: 978-94-010-9005-6 e-lSBN-13: 978-94-009-5676-6
DOl: 10.1007/978-94-009-5676-6
Copyright
© 1984 by Martinus Nijhoff Publishers, Dordrecht.
Softcover reprint of the hardcover 1 st edition 1984
All rights reserved. No part of this publication may be reproduced, stored in a
retrieval system, or transmitted in any form or by any means, mechanical,
photocopying, recording, or otherwise, without the prior written permission of
the publishers,
Martinus Nijhoff Publishers, P.O. Box 163, 3300 AD Dordrecht,
The Netherlands.
v
PREFACE
This volume contains all relevant information discussed in a
Workshop on thromboplastin calibration held in Leiden, The
Netherlands on July 1, 1983. The Workshop was an initiative of
the Dutch foundation for a Reference Laboratory for Anticoagulant
Control (RELAC) and it was organized by the Boerhaave Committee
for postgraduate teaching of the Faculty of Medicine of the
University of Leiden. The Workshop was held under the auspices of
five organizations i.e. the European Community Bureau of Refer
ence (BCR) , the European Committee for Clinical Laboratory
Standards (ECCLS), the International Association of Biological
Standardization (lABS), the International Committee for Standar
dization in Haematology (ICSH), ·and the International Committee
on Thrombosis and Haemostasis (ICTH). The aim of the Workshop was
to discuss and develop a method for calibration of reagents, i.e.
thromboplastins and/or plasmas used for the prothrombin time.
During the Workshop three recent thromboplastin calibration
studies were discussed, the results of which are presented in
chapters 4, 7 and 9. These studies were carried out on the basis
of a new calibration model developed by experts working with BCR
and WHO. The usefulness of this model and the standardization
system based on it is the leading thread running through this
volume. Statisticians and clinicians discuss the results from a
scientific point of view. Thromboplastin manufacturers, for whom
especially the use of the model and the system is intended,
discuss the matter also from an economic and legal point of view.
Before the Workshop, one of the commercial manufacturers
requested to present data of an additional study in which a newly
developed reagent was compared with Manchester Comparative
VI
Reagent. This request was granted (chapter 11) but an editorial
comment has been added. Furthermore, Dr. Duxbury, a user of
British comparative Thromboplastin, requested to give his views
on thromboplastin nomenclature (chapter 10).
Shortly after the Workshop, in September 1983, the proposed
International Reference Thromboplastin human, plain (BCT/253) was
accepted by the Expert Committee on Biological Standardization of
WHO to replace the original International Reference Preparation,
human, combined (code no. 67/40). Thus, the British system of
oral anticoagulant control has been intertwined with the WHO
system as decribed in chapter 9.
At the conclusion of the Workshop, a draft policy statement
for reporting the prothrombin time in oral ~nticoagulant control
was discussed. This policy statement was slightly modified by the
ICTH subcommittee for standardization of the prothrombin time at
its meeting on July 3, in Stockholm, and was agreed on in prin
ciple by both the ICTH and the ICSH. The text given in chapter 14
is the final draft which has been submitted for approval to the
members of ICSH and ICTH.
This volume contains a wealth of numerical data and protocols
of the calibration studies. This information will be useful to
anybody involved in thromboplastin calibration. This includes not
only thromboplastin manufacturers, but also anybody concerned
with the control of oral anticoagulant treatment.
We thank everybody who contributed to the success of the
Workshop, especially Dr. E.A. Loeliger who has been the driving
force. We also thank Hellen de Roan, Suzan Leenheer and Emmy
Vletter for typing the manuscripts.
November 1983 A.M.H.P. van den Besselaar
H.R. Gralnick
S.M. Lewis
VII
CONTENTS pp.
Preface v
Contributors ix
Acknowledgements xi
1. Introduction 1
E.A. Loeliger and A.M.H.P. van den Besselaar
2. General Aspects of Thromboplastin Calibration 11
T.B.L. Kirkwood
3. Orthogonal Regression Equation 25
E.A. van der Velde
4. The European Community Bureau of Reference Calibration
Study 41
J. Hermans
87
5. A Statistician's Independent Evaluation
J.A. Tomenson
6. Critical Remarks from a Clinician's Point of View 109
E.A. Loeliger
Discussion: L. Poller, E.A. Loeliger, J.A. Tomenson, E.
Colinet, N.K. Shinton, T.B.L. Kirkwood, R.
Spaethe, F. Dornbrose, E.A. van der Velde 117
7. The Manufacturers' Calibration Study 127
A.M.H.P. van den Besselaar and E.A. van der Velde
8. INR Ranges and Targets for Oral Anticoagulation to be
Effective and Safe 151
E.A. Loeliger
Discussion: R. Spaethe, A.M.H.P. van den Besselaar, E.A.
Loeliger, K.W.E. Denson, R.M. Bertina,
T.B.L. Kirkwood, E.A. van der Velde, J.A.
Koepke, H.R. Gralnick, J.A. Tomenson, T.
Geiger 159
9. The British System of Oral Anticoagulant Control and its
Relation with the W.H.O. System: Calibration of the
Proposed Second W.H.O. International Reference Thrombo-
plastin (BCT/253) 165
J.A. Tomenson, J.M. Thomson and L. Poller
10. Anomalies of Thromboplastin Nomenclature 195
B.McD. Duxbury
11. Comparison of a Highly Sensi tive Rabbit Brain Thrombo
plastin, Dade Thromboplastin FS, with a Human Brain
Thromboplastin, Manchester Comparative Thromboplastin 197
R. Spaethe and I. Shirley
VIII
pp.
Comment on Dr. Spaethe's contribution 207
A.M.H.P. van den Besselaar
12. Proficiency Testing and Standardization of Prothrombin
Time - Potential Use of Thromboplastin Calibration in
the United states 209
D.A. Triplett, B.L. Evatt and A.M.H.P. van den Besselaar
13. The Relationship between the International Normalized
Ratio and the Coumarin-Induced Coagulation Defect 223
R.M. Bertina
Discussion: E.A. Loeliger, M. Samama, R.M. Bertina, H.R.
Gralnick, J.A. Koepke, S.M. Lewis, L.
Poller, K.W.E. Denson, J.A. Tomenson, D.A.
Triplett, T. Geiger, J.G. Lenahan 235
14. Joint ICTH/ICSH Proposed Policy Statement with Respect
to Reporting the Prothrombin Time in Oral Anticoagulant
Control 241
Discussion: S.M. Lewis, J.C. Koedam, T.B.L. Kirkwood, L.
Poller, J.A. Tomenson, F. Dombrose, M.
Samama 249
15. A Manufacturer's View of Thromboplastin Calibration (I) 253
D.J. Baughman
16. A Manufacturer's View of Thromboplastin Calibration (II) 257
J.G. Lenahan
Index 259
IX
CONTRIBUTORS
D.J. Baughman
Or tho Diagnostics, Inc., Raritan, New Jersey, U.S.A.
R.M. Bertina
Hemostasis and Thrombosis Research Unit, University Hospital,
Leiden, The Netherlands
A.M.H.P. van den Besselaar
Reference Laboratory for Anticoagulant Control, University
Hospital, Leiden, The Netherlands
B.McD. Duxbury
Chase Farm Hospital, Enfield, United Kingdom
B.L. Evatt
Centers for Disease Control, Host Factors Division, Atlanta,
Georgia, U.S.A.
H.R. Gralnick
Haematology Service, Clinical Center, National Institutes of
Health, Bethesda, Maryland, U.S.A.
J. Hermans
Department of Medical Statistics, University of Leiden,
Leiden, The Netherlands
T.B.L. Kirkwood
National Institute for Medical Research, The Ridgeway, Mill
Hill, London, United Kingdom
J.G. Lenahan
General Diagnostics, Morris Plains, New Jersey, U.S.A.
x
S.M. Lewis
Department of Haematology, Royal Postgraduate Medical School,
Hammersmith Hospital, London, United Kingdom
E.A. Loeliger
Hemostasis and Thrombosis Research Unit, University Hospital,
Leiden, The Netherlands
L. Poller
National (UK) Reference Laboratory for Anticoagulant Reagents
and Control, Withington Hospital, Manchester, United Kingdom
I. Shirley
St. Vincent's Hospital, Dublin, Ireland
R. Spaethe
American Hospital Supply Deutschland GmbH, Department Merz +
Dade, Mlinchen, German Fedpral Republic
J.M. Thomson
National (UK) Reference Laboratory for Anticoagulant Reagents
and Control, Withington Hospital, Manchester, United Kingdom
J.A. Tomenson
National (UK) Reference Laboratory for Anticoagulant Reagents
and Control, Withington Hospital, Manchester, United Kingdom
D.A. Triplett
Ball Memorial Hospital, Department of Pathology, Muncie,
Indiana, U.S.A.
E.A. van der Velde
Department of Medical Statistics, University of Leiden,
Leiden, The Netherlands