NovoSeven In Critical Care - Evaluation

About NICE Registry

As all of us are aware, NovoSeven (rFVIIa), has been available for clinical use in India for over some time.

Though, it is primarily indicated for the treatment of bleeding episodes and for prevention of bleeding during surgery in patients with congenital haemophilia with inhibitors to factors VIII or IX; acquired haemophilia; congenital FVII deficiency and Glanzmann thrombasthenia not responding to platelet transfusions (approved indications for NovoSeven available in EU and other countries), recently a large number of reports, case-series and, anecdotal evidences and some randomized trials have now shown that NovoSeven could actually be a valuable haemostatic agent in other bleeding conditions. A growing body of evidence world over indicates that rFVIIa may have an important role as a valuable haemostatic in intra cranial haemorrhage, trauma, surgery, liver disease-associated bleeds, thrombocytopenia, and anticoagulant over-dosage or toxicity.

NovoSeven in Critical Care - Evaluation (NICE) Registry - Rationale

Based on the above data, even in India NovoSeven is being used by many healthcare specialists to treat bleeds of varied aetiology. It is important therefore that such data be pooled and analyzed to gain further knowledge and insights that will improve care of critical patients. In the absence of formal registry, much of this important safety and efficacy data are currently going undocumented. In light of this, NICE registry has been set up to track the use of this important product especially in non-hemophiliac indications.

Objectives

• To register as many patients as possible who have received NovoSeven as treatment for severe hemorrhages
• To analyze all available data and experiences with NovoSeven to obtain new insights and information on the optimal use of this drug (especially in non-hemophiliac patients)
• To motivate as many Indian clinicians as possible who have been involved in NovoSeven cases to submit their data and experiences with NovoSeven
• To offer updated information and potential guidelines about the clinical use of NovoSeven Registry in newer indications.

This project which has been conceived by the NovoSeven Advisory Board (NAB) will be maintained at Department of Haematology, Christian Medical College, Vellore. The proposed registry will be sponsored by an unrestricted educational grant from Novo Nordisk India Pvt. Ltd. The NAB currently consists of Dr.Alok Srivastava, CMC, Vellore, Dr.M.B.Agarwal, Bombay Hospital, Mumbai, Dr. Palepu Gopal,Hyderbad,Global Hospital and Dr. Rajesh Pande,Delhi, B.L.Kapoor Hospital. All patient data shall be maintained and reviewed by the NAB and the Department of Haematology, CMC, Vellore. NICE Registry will be used to capture information regarding the off label uses of rFVIIa (other than use in patients with haemophilia) in a variety of bleeding conditions. It will be our endeavour to see that every 6 to 12 months major findings and conclusions from this registry will be shared with all participants and disseminated through appropriate scientific forums. All those physicians providing the data will be duly acknowledged.

Dr.Alok Srivastava, MD, FRACP, FRCPA, FRCP
Professor and Head,
Department of Haematology,
Christian Medical College,
Vellore - 632 004,
TamilNadu.