Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients

The definition of major bleeding varies between studies on surgical patients, particularly regarding the criteria for surgical wound‐related bleeding. This diversity contributes to the difficulties in comparing data between trials. The Scientific and Standardization Committee (SSC), through its subc...

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Vydáno v:	Journal of thrombosis and haemostasis Ročník 8; číslo 1; s. 202 - 204
Hlavní autoři:	SCHULMAN, S., ANGERÅS, U., BERGQVIST, D., ERIKSSON, B., LASSEN, M. R., FISHER, W.
Médium:	Journal Article
Jazyk:	angličtina
Vydáno:	Oxford, UK Blackwell Publishing Ltd 01.01.2010
Témata:	Anticoagulants - adverse effects Anticoagulation Blood Loss, Surgical - mortality Blood Transfusion Double-Blind Method Fibrinolytic Agents - adverse effects Hemoglobins - metabolism Hemorrhage Humans Kirurgi MEDICIN MEDICINE Platelet inhibition Postoperative Hemorrhage - blood Postoperative Hemorrhage - etiology Postoperative Hemorrhage - mortality Postoperative Hemorrhage - surgery Randomized Controlled Trials as Topic - standards Reoperation Severity of Illness Index Societies, Medical Surgery Terminology as Topic Time Factors
ISSN:	1538-7933, 1538-7836, 1538-7836
On-line přístup:	Získat plný text
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Abstract	The definition of major bleeding varies between studies on surgical patients, particularly regarding the criteria for surgical wound‐related bleeding. This diversity contributes to the difficulties in comparing data between trials. The Scientific and Standardization Committee (SSC), through its subcommittee on Control of Anticoagulation, of the International Society on Thrombosis and Haemostasis has previously published a recommendation for a harmonized definition of major bleeding in non‐surgical studies. That definition has been adopted by the European Medicines Agency and is currently used in several non‐surgical trials. A preliminary proposal for a parallel definition for surgical studies was presented at the 54th Annual Meeting of the SSC in Vienna, July 2008. Based on those discussions and further consultations with European and North American surgeons with experience from clinical trials a definition has been developed that should be applicable to all agents that interfere with hemostasis. The definition and the text that follows have been reviewed and approved by relevant co‐chairs of the subcommittee and by the Executive Committee of the SSC. The intention is to seek approval of this definition from the regulatory authorities to enhance its incorporation into future clinical trial protocols.
AbstractList	The definition of major bleeding varies between studies on surgical patients, particularly regarding the criteria for surgical wound-related bleeding. This diversity contributes to the difficulties in comparing data between trials. The Scientific and Standardization Committee (SSC), through its subcommittee on Control of Anticoagulation, of the International Society on Thrombosis and Haemostasis has previously published a recommendation for a harmonized definition of major bleeding in non-surgical studies. That definition has been adopted by the European Medicines Agency and is currently used in several non-surgical trials. A preliminary proposal for a parallel definition for surgical studies was presented at the 54th Annual Meeting of the SSC in Vienna, July 2008. Based on those discussions and further consultations with European and North American surgeons with experience from clinical trials a definition has been developed that should be applicable to all agents that interfere with hemostasis. The definition and the text that follows have been reviewed and approved by relevant co-chairs of the subcommittee and by the Executive Committee of the SSC. The intention is to seek approval of this definition from the regulatory authorities to enhance its incorporation into future clinical trial protocols. The definition of major bleeding varies between studies on surgical patients, particularly regarding the criteria for surgical wound-related bleeding. This diversity contributes to the difficulties in comparing data between trials. The Scientific and Standardization Committee (SSC), through its subcommittee on Control of Anticoagulation, of the International Society on Thrombosis and Haemostasis has previously published a recommendation for a harmonized definition of major bleeding in non-surgical studies. That definition has been adopted by the European Medicines Agency and is currently used in several non-surgical trials. A preliminary proposal for a parallel definition for surgical studies was presented at the 54(th) Annual Meeting of the SSC in Vienna, July 2008. Based on those discussions and further consultations with European and North American surgeons with experience from clinical trials a definition has been developed that should be applicable to all agents that interfere with hemostasis. The definition and the text that follows have been reviewed and approved by relevant co-chairs of the subcommittee and by the Executive Committee of the SSC. The intention is to seek approval of this definition from the regulatory authorities to enhance its incorporation into future clinical trial protocols.The definition of major bleeding varies between studies on surgical patients, particularly regarding the criteria for surgical wound-related bleeding. This diversity contributes to the difficulties in comparing data between trials. The Scientific and Standardization Committee (SSC), through its subcommittee on Control of Anticoagulation, of the International Society on Thrombosis and Haemostasis has previously published a recommendation for a harmonized definition of major bleeding in non-surgical studies. That definition has been adopted by the European Medicines Agency and is currently used in several non-surgical trials. A preliminary proposal for a parallel definition for surgical studies was presented at the 54(th) Annual Meeting of the SSC in Vienna, July 2008. Based on those discussions and further consultations with European and North American surgeons with experience from clinical trials a definition has been developed that should be applicable to all agents that interfere with hemostasis. The definition and the text that follows have been reviewed and approved by relevant co-chairs of the subcommittee and by the Executive Committee of the SSC. The intention is to seek approval of this definition from the regulatory authorities to enhance its incorporation into future clinical trial protocols. The definition of major bleeding varies between studies on surgical patients, particularly regarding the criteria for surgical wound-related bleeding. This diversity contributes to the difficulties in comparing data between trials. The Scientific and Standardization Committee (SSC), through its subcommittee on Control of Anticoagulation, of the International Society on Thrombosis and Haemostasis has previously published a recommendation for a harmonized definition of major bleeding in non-surgical studies. That definition has been adopted by the European Medicines Agency and is currently used in several non-surgical trials. A preliminary proposal for a parallel definition for surgical studies was presented at the 54(th) Annual Meeting of the SSC in Vienna, July 2008. Based on those discussions and further consultations with European and North American surgeons with experience from clinical trials a definition has been developed that should be applicable to all agents that interfere with hemostasis. The definition and the text that follows have been reviewed and approved by relevant co-chairs of the subcommittee and by the Executive Committee of the SSC. The intention is to seek approval of this definition from the regulatory authorities to enhance its incorporation into future clinical trial protocols.
Author	FISHER, W. BERGQVIST, D. LASSEN, M. R. ERIKSSON, B. SCHULMAN, S. ANGERÅS, U.
Author_xml	– sequence: 1 givenname: S. surname: SCHULMAN fullname: SCHULMAN, S. – sequence: 2 givenname: U. surname: ANGERÅS fullname: ANGERÅS, U. – sequence: 3 givenname: D. surname: BERGQVIST fullname: BERGQVIST, D. – sequence: 4 givenname: B. surname: ERIKSSON fullname: ERIKSSON, B. – sequence: 5 givenname: M. R. surname: LASSEN fullname: LASSEN, M. R. – sequence: 6 givenname: W. surname: FISHER fullname: FISHER, W.
BackLink	https://www.ncbi.nlm.nih.gov/pubmed/19878532$$D View this record in MEDLINE/PubMed https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-110102$$DView record from Swedish Publication Index (Uppsala universitet) https://gup.ub.gu.se/publication/108800$$DView record from Swedish Publication Index (Göteborgs universitet)
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Cites_doi	10.1177/1076029609338712 10.1016/j.ejvs.2008.06.030 10.1111/j.1538-7836.2005.01204.x
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SubjectTerms	Anticoagulants - adverse effects Anticoagulation Blood Loss, Surgical - mortality Blood Transfusion Double-Blind Method Fibrinolytic Agents - adverse effects Hemoglobins - metabolism Hemorrhage Humans Kirurgi MEDICIN MEDICINE Platelet inhibition Postoperative Hemorrhage - blood Postoperative Hemorrhage - etiology Postoperative Hemorrhage - mortality Postoperative Hemorrhage - surgery Randomized Controlled Trials as Topic - standards Reoperation Severity of Illness Index Societies, Medical Surgery Terminology as Topic Time Factors
Title	Definition of major bleeding in clinical investigations of antihemostatic medicinal products in surgical patients
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