Clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in patients undergoing high VTE-risk surgery - Scientific guideline

This document provides guidance for the evaluation of new medicinal products in the primary prophylaxis of high intra- and post-operative venous thrombo-embolic risk.

Keywords: CHMP, venous thromboembolic risk

Current effective version

Guideline on clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in patients undergoing high VTE-risk surgery - Revision 2

Adopted Reference Number: EMA/CHMP/325170/2012 Legal effective date: 30/05/2013 Summary:

This guideline is a revision of the CHMP Guideline on clinical investigation of medicinal products for Prophylaxis of Intra- and Post-operative Venous Thromboembolic Risk (CPMP/EWP/707/98 Rev.1 corr). Revision 1 was intended to provide guidance for the evaluation of new medicinal products in the primary prophylaxis of high intra- and post-operative venous thrombo-embolic risk.

Document history - Revision 2 (current)

Guideline on clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in patients undergoing high VTE-risk surgery - Revision 2

Adopted Reference Number: EMA/CHMP/325170/2012 Legal effective date: 30/05/2013 Summary:

This guideline is a revision of the CHMP Guideline on clinical investigation of medicinal products for Prophylaxis of Intra- and Post-operative Venous Thromboembolic Risk (CPMP/EWP/707/98 Rev.1 corr). Revision 1 was intended to provide guidance for the evaluation of new medicinal products in the primary prophylaxis of high intra- and post-operative venous thrombo-embolic risk.

Overview of comments received on 'Guideline on clinical investigation of medicinal products for prophylaxis of high intra- and post-operative venous thromboembolic risk'

Reference Number: EMA/CHMP/47495/2013

Draft guideline on clinical investigation of medicinal products for prevention of venous thromboembolism (VTE) in patients undergoing high VTE-risk surgery - Revision 2

Draft: consultation closed Consultation dates: 30/05/2012 to 30/11/2012 Reference Number: EMA/CHMP/325170/2012 Summary:

This guideline is a revision of the Committee for Medicinal Products for Human Use guideline on clinical investigation of medicinal products for prophylaxis of intra- and post-operative venous thromboembolic risk (CPMP/EWP/707/98 Rev.1 corr). Revision 1 was intended to provide guidance for the evaluation of new medicinal products in the primary prophylaxis of high intra- and post-operative venous thromboembolic risk.

Concept paper on the need for revision of the guideline on clinical investigation of medicinal products for prophylaxis of high intra- and post-operative venous thromboembolic risk

Draft: consultation closed Consultation dates: 23/06/2011 to 30/09/2011 Reference Number: EMA/CHMP/114599/2011 Summary:

A key element in the benefit risk assessment of drugs used for prophylaxis of venous thromboembolism (VTE) is balancing their antithrombotic effect versus the risk of bleeding. The high variability in the assessment and reporting of bleedings, perioperative blood loss and transfusions in orthopaedic VTE prevention trials has the potential to impact the interpretation of results of individual randomized controlled trials and, ultimately, makes difficult the benefit-risk assessment of new antithrombotics.

Document history - Revision 1

Guideline on clinical investigation of medicinal products for prophylaxis of high intra- and post-operative venous thromboembolic risk - Revision 1

Adopted Reference Number: CPMP/EWP/707/98 Rev.1 corr Legal effective date: 31/05/2008

Overview of comments received on draft guideline on clinical investigation of medicinal products for prophylaxis of high intra- and post-operative venous thromboembolic risk - Revision 1

Reference Number: EMEA/519459/2007

Draft guideline on clinical investigation of medicinal products for prophylaxis of high intra- and post-operative venous thromboembolic risk - Revision 1

Draft: consultation closed Reference Number: CPMP/EWP/707/98 Rev. 1

Recommendations on the need for revision of the guideline on clinical investigation of medicinal products for prophylaxis of intra- and post- operative venous thromboembolic risk (CPMP/EWP/707/98)

Adopted Reference Number: EMEA/CHMP/340660/2005

Document history - First version

Points to consider on clinical investigation of medicinal products for prophylaxis of high intra- and post-operative venous thromboembolic risk

Reference Number: CPMP/EWP/707/98