Clinical trial NCT03251547: Recombinant Activated Factor VII in the Management of Massive Bleeding in Hospital Universiti Sains Malaysia
Official title: Recombinant Activated Factor VII (rFVIIa/ NovoSeven®) in the Management of Massive Bleeding in Hospital Universiti Sains Malaysia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Massive Hemorrhage
Massive Blood Loss
Massive Blood Transfusion; Thrombocytopenia
Keywords: rFVIIa
Massive Hemorrhage
non-hemophilia
Lead sponsor: Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2017-08-16
Enrollment: 76
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Non-haemophilic patients who had received rFVIIa during massive bleeding in Hospital Universiti Sains Malaysia (HUSM)

Brief summary: 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)

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in blood transfusion requirement
timeFrame: 24 hour before and after administration of rFVIIa
measure: Survival rate
timeFrame: 30 days
Secondary outcomes:
measure: Changes in coagulation profile
timeFrame: 24 hour before and after administration of rFVIIa
Other outcomes:
measure: Complication rate
timeFrame: 30 days
Locations:
city: Kota Bharu
country: Malaysia
facility: Hospital Universiti Sains Malaysia
state: Kelantan
Study officials:
affiliation: Universiti Sains Malaysia
name: Chong Soon Eu, MD, MMed
role: STUDY_CHAIR
affiliation: Universiti Sains Malaysia
name: Nurfatin Mohd Shah, BSc
role: PRINCIPAL_INVESTIGATOR
References:
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