Massive Hemorrhage Clinical Trial
Official title:
Recombinant Activated Factor VII (rFVIIa/ NovoSeven®) in the Management of Massive Bleeding in Hospital Universiti Sains Malaysia
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)
Effective hemostasis can be life-saving. However, there is still lack of an ideal hemostatic
drug which is safe and effective.
Recombinant activated factor VII (rFVIIa; Novo Nordisk, Bagsvaerd, Denmark) is a hemostatic
agent originally developed for the management of bleeding in haemophilia A and B patients
with inhibitors to factor VIII or IX respectively.
Recombinant FVIIa involves in extrinsic clotting pathway where it forms a complex with tissue
factor which in the presence of calcium and phospholipids activates coagulation factor X
which then initiates the conversion of prothrombin into thrombin at the site of injury
(Figure 1). Formation of thrombin and clot stabilises platelet plug and form a tight fibrin
structure which is resistant to lysis. Due to the efficient haemostatic property but the
unknown safety profile, it is only being used as one of the last resorts during massive
intractable bleeding episode among the non-haemophilia patients.
Efficacy and safety profile is the most important concern of a haemostatic drug like rFVIIa.
However, there is ongoing controversial evidence regarding thromboembolic complications and
survival benefit of the off-label use of rFVIIa in massive bleeding (Patel et al2012).
This a study to learn about the previous usage, outcome and complications of rFVIIa use in
massive intractable bleeding management in a single centre (Hospital University Sains
Malaysia / HUSM) in Malaysia.
The data of patients who had undergone massive bleeding will be available from pharmacy
department and recruited from medical record department of HUSM.
These include:
1. Underlying condition, BMI of patient.
2. Indication for blood transfusion.
3. Dose of rFVIIa.
4. Other medication (vitamin K, tranexamic acid, anticoagulant, antiplatelet) given to
patient.
5. Blood pressure, haemoglobin level, coagulation profile, and blood product requirements
24 hours before and after administration of rFVIIa.
6. Survival at 24-hour and day-30 post administration of rFVIIa were also recorded.
7. Thromboembolism complication post administration of rFVIIa.
8. Duration of stay.
Patients' identities will be anonymized without disclosure of personal identifiable
information to third-party organizations.
Statistical calculations will be done using SPSS (Statistical Package for the Social Science)
software.
Quantitative data will be expressed as mean ± standard deviation (SD) and median
(interquartile range,IQR). For comparison before and after of administration of rFVIIa, data
will be analyzed using paired t- test if the data is normally distributed. For skewed data,
Wilcoxon Signed-Rank test will be used for analysis. The differences willl be considered
significant at a p < 0.05.
For the outcome of survival and thromboembolic complication, data will be analyzed
descriptively with frequency and percentage.
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