Massive Hemorrhage Clinical Trial
Official title:
Recombinant Activated Factor VII (rFVIIa/ NovoSeven®) in the Management of Massive Bleeding in Hospital Universiti Sains Malaysia
NCT number | NCT03251547 |
Other study ID # | SEChong |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | August 21, 2017 |
Est. completion date | November 15, 2017 |
Verified date | October 2018 |
Source | University of Science Malaysia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is a retrospective descriptive study, to study the treatment indications, changes in transfusion need, coagulation profiles changes and clinical outcome (survival, complication) of non-haemophiliac patients who received activated factor seven (rFVIIa / NovoSeven®) during massive bleeding in Hospital Universiti Sains Malaysia (HUSM)
Status | Completed |
Enrollment | 76 |
Est. completion date | November 15, 2017 |
Est. primary completion date | October 15, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - All patient with massive bleeding who had received rFVIIa from year 2006 to year 2016. - Massive bleeding criteria - Loss of one blood volume within a 24 hour - 50% blood volume loss within 3 h - Rate of loss of 150 ml/min Exclusion Criteria: - Haemophilia patient who received rFVIIa - Poor documentation / record unavailable in HUSM |
Country | Name | City | State |
---|---|---|---|
Malaysia | Hospital Universiti Sains Malaysia | Kota Bharu | Kelantan |
Lead Sponsor | Collaborator |
---|---|
University of Science Malaysia |
Malaysia,
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Faraoni D, Van Der Linden P. A systematic review of antifibrinolytics and massive injury. Minerva Anestesiol. 2014 Oct;80(10):1115-22. Epub 2013 Nov 28. Review. — View Citation
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Kobayashi T, Nakabayashi M, Yoshioka A, Maeda M, Ikenoue T. Recombinant activated factor VII (rFVIIa/NovoSeven®) in the management of severe postpartum haemorrhage: initial report of a multicentre case series in Japan. Int J Hematol. 2012 Jan;95(1):57-63. doi: 10.1007/s12185-011-0974-9. Epub 2011 Dec 9. — View Citation
Lin Y, Moltzan CJ, Anderson DR; National Advisory Committee on Blood and Blood Products. The evidence for the use of recombinant factor VIIa in massive bleeding: revision of the transfusion policy framework. Transfus Med. 2012 Dec;22(6):383-94. doi: 10.1111/j.1365-3148.2012.01164.x. Epub 2012 May 27. Review. — View Citation
Logan AC, Goodnough LT. Recombinant factor VIIa: an assessment of evidence regarding its efficacy and safety in the off-label setting. Hematology Am Soc Hematol Educ Program. 2010;2010:153-9. doi: 10.1182/asheducation-2010.1.153. Review. — View Citation
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Spahn DR, Bouillon B, Cerny V, Coats TJ, Duranteau J, Fernández-Mondéjar E, Filipescu D, Hunt BJ, Komadina R, Nardi G, Neugebauer E, Ozier Y, Riddez L, Schultz A, Vincent JL, Rossaint R. Management of bleeding and coagulopathy following major trauma: an updated European guideline. Crit Care. 2013 Apr 19;17(2):R76. doi: 10.1186/cc12685. Review. — View Citation
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* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Complication rate | To describe the outcome of complication of non-hemophiliac patient after receiving rFVIIa | 30 days | |
Primary | Changes in blood transfusion requirement | To study the changes in blood product requirement in 24 hours before and after administration of rFVIIa in massive bleeding patient in HUSM and to describe the factors affecting it. | 24 hour before and after administration of rFVIIa | |
Primary | Survival rate | To describe the outcome of survival at 24-hour and Day-30 after receiving rFVIIa | 30 days | |
Secondary | Changes in coagulation profile | To study the changes in coagulation profile in 24 hours before and after administration of rFVIIa in massive bleeding patient in HUSM and to describe the factors affecting it | 24 hour before and after administration of rFVIIa |
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