Recombinant Activated Factor VII in the Management of Massive Bleeding in Hospital Universiti Sains Malaysia

October 9, 2018 updated by: Soon Eu Chong, Universiti Sains Malaysia

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)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
    • Kelantan
      • Kota Bharu, Kelantan, Malaysia, 16150
        • Hospital Universiti Sains Malaysia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Non-haemophilic patients who had received rFVIIa during massive bleeding in Hospital Universiti Sains Malaysia (HUSM)

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
NovoSeven
Non-hemophiliac patients experienced massive haemorrhage who was treated with recombinant activated factor VII
Drug: NovoSeven
To survey retrospectively the treatment indications, clinical outcome, transfusion need and changes in coagulation profiles of non-haemophiliac patients who had received rFVIIa during massive bleeding
Other Names:
  • recombinant activated factor VII

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in blood transfusion requirement
Time Frame: 24 hour before and after administration of rFVIIa
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
Survival rate
Time Frame: 30 days
To describe the outcome of survival at 24-hour and Day-30 after receiving rFVIIa
30 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in coagulation profile
Time Frame: 24 hour before and after administration of rFVIIa
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complication rate
Time Frame: 30 days
To describe the outcome of complication of non-hemophiliac patient after receiving rFVIIa
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universiti Sains Malaysia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Chong Soon Eu, MD, MMed, Universiti Sains Malaysia
  • Principal Investigator: Nurfatin Mohd Shah, BSc, Universiti Sains Malaysia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 21, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 15, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 10, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 9, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SEChong

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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