Registry Study of COAGADEX® Patients With Moderate or Severe Hereditary Factor X Deficiency Undergoing Major Surgery

A Multicenter, Post-Marketing Registry Study of COAGADEX® in the Peri-operative Management of Patients With Moderate or Severe Hereditary Factor X Deficiency Undergoing Major Surgery

This is a non-interventional, multicenter, post-marketing registry study in three patients with moderate or severe hereditary FX deficiency, to assess Coagadex administered peri-operatively for hemostatic cover in major surgery during routine post-marketing use.

Study Overview

• Status: Completed
• Conditions: Factor 10 Deficiency
• Intervention / Treatment: Drug: Coagadex

Detailed Description

The primary objective is to collect additional surgical data on the clinical effectiveness of Coagadex, in a post-marketing environment, for peri-operative hemostatic cover during major surgery in patients with moderate or severe hereditary factor X (FX) deficiency.

The secondary objective is to review safety data on Coagadex through the collection of any Adverse Drug Reactions (ADRs) from the first dose of Coagadex in the hospital prior to the surgical procedure until the first follow-up after discharge (i.e., follow-up completed) and Serious ADRs up until the post-operative care follow-up has been completed. Data on any deaths and pregnancies reported within this time period will be collected.

• Study Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida Health
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Tulane University Hospitals and Clinics
  • Michigan
    • Kalamazoo, Michigan, United States, 49007
      • West Michigan Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with moderate or severe hereditary Factor X deficiency undergoing major surgery.

Description

Inclusion Criteria:

• Patients >12 years of age with severe or moderate hereditary FX deficiency. Severe is defined as <1 IU/dL and moderate as 1 to 5 IU/dL (3)
• Patients who have given written informed consent (for sites in the USA this will include the Health Insurance Portability and Accountability Act (HIPAA) authorization statement), OR, in the case of 12-18 year olds, written informed consent from the parents/ guardians and where appropriate assent from the child

• Patients requiring major surgery. Major surgery is defined as procedures typically requiring:

  • full anesthesia or regional anesthesia, e.g. epidural or spinal and
  • involving the opening of major cavities such as thoracic, abdominal surgery; orthopedic surgery, and Caesarean section (C-section) and
  • requiring at least one overnight stay in hospital (16)

Exclusion Criteria:

• Patients known to be pregnant, unless the surgery is C-section.
• Patients who participated in a clinical study trial in the last 30 days prior to study enrolment, except if they have been involved in another study involving Coagadex.
• Patients with a known history of inhibitor development to FX.
• Patients who are required or expected to take other factor X-containing medications during or after surgery.
• Patients with existing known thrombocytopenia (platelets < 50 x 109/L).
• Patients with existing known clinically significant renal disease (creatinine >200 µmol/L).
• Patients with existing known clinically significant liver disease (ALT levels greater than three times the upper limit of normal).
• Patients with existing known other coagulopathy or thrombophilia.
• Patients with a known intolerance or allergy to Coagadex or its excipients.
• Patients known to have abused chemicals or drugs within the past 12 months.
• Patients with a history of unreliability or non-cooperation.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Moderate to Severe Factor X Deficiency	Drug: Coagadex; Plasma-driven blood coagulation factor X concentration; Other Names: Factor X

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retrospective surgical data collection	Blood loss (mL)	12 months

Collaborators and Investigators

• Sponsor: Bio Products Laboratory

Study record dates

Study Major Dates

• Study Start (Actual): February 27, 2018
• Primary Completion (Actual): October 13, 2021
• Study Completion (Actual): October 13, 2021

Study Registration Dates

• First Submitted: May 18, 2017
• First Submitted That Met QC Criteria: May 18, 2017
• First Posted (Actual): May 22, 2017

Study Record Updates

• Last Update Posted (Actual): November 12, 2021
• Last Update Submitted That Met QC Criteria: November 11, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Blood Coagulation Disorders; Factor X Deficiency
• Other Study ID Numbers: Ten06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No