Reversal Agent Use in Patients Treated With Direct Oral Anticoagulants (RADOA)

This study is not yet open for participant recruitment.
Verified May 2013 by Johann Wolfgang Goethe University Hospitals
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. E. Lindhoff-Last, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT01722786
First received: November 5, 2012
Last updated: May 8, 2013
Last verified: May 2013
  Purpose

Patients treated with Vitamin K antagonists (VKA) or direct oral anticoagulants as Rivaroxaban, Apixaban, Edoxaban or Dabigatran, who experience severe bleeding and/or need urgent interventions/operations that cannot wait are included in this registry, when they receive intervention with a reversal agent (e.g. PCC, aPCC; rVIIa and/or hemodialysis (for removal of dabigatran)).


Condition
Severe Bleeding
Urgent Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Observational, Non-interventional Open-label Multicenter Registry Regarding the Management of Severe Bleeding and/or Urgent Interventions During Treatment With Direct Oral Anticoagulants

Resource links provided by NLM:


Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • Primary Outcome [ Time Frame: open ] [ Designated as safety issue: Yes ]
    1. Stop of bleeding
    2. Fatality rate caused by non-stop bleeding
    3. In case of urgent operation satisfaction of surgeon during and after surgery concerning bleeding using a standardized questionnaire


Secondary Outcome Measures:
  • Secondary Outcome [ Time Frame: open ] [ Designated as safety issue: Yes ]
    1. use versus no use of reversal agents - difference in outcome?
    2. definition of supportive measures being effective in stopping bleeding
    3. effectiveness of dialysis vs. no dialysis in case of dabigatran accumulation associated with bleeding


Biospecimen Retention:   Samples Without DNA

If possible, left-over from plasma samples ("retention sample") should be used to perform further analyses as drug concentrations. Retention samples of very low volume would suffice for HPLC (information on collection method needed) to assess plasma concentrations of anticoagulants in these patients.


Estimated Enrollment: 130
Study Start Date: August 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
DOA
Group 1: 130 patients treated with DOA
VKA
Group 2: 130 treated with VKA

Detailed Description:

The Registry will offer the opportunity to evaluate the effects of reversal agents as PCC, aPCC, rVIIa in e.g. severe bleeding patients treated with oral anticoagulants.

By collecting case reports from several university hospitals and clinics, different treatment strategies in clinical practice will be observed and evaluated, and may serve as a comprehensive information resource for the safe management with DOA, but also with the long-term anticoagulation based on coumarin derivatives in the near future.

Study Registry Design Prospective, Observational, Non-interventional Open-label Multicenter and International

  1. Non-interventional: TBC as specific analyses are planned on retention blood samples which are taken anyhow during patient management
  2. Prospective: inclusion into the registry will be done when the acute emergency situation has passed
  3. Observational: Treatment decision will be at the discretion of the treating physician based on individual patients situation The decision to enter the patient into the registry will occur after all treatment decisions have been taken.

The Main Registry Objective of this Registry is to:

  1. Document the clinical course, incidence and outcome of various clinical bleeding events associated with DOA in patients with severe bleeding making intervention necessary or who need urgent intervention/surgery that cannot wait AND
  2. Evaluate the effectiveness of their responses to its intervention treatment including: a. reversal agent; b. haemodialysis; c. waiting;
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

N= 130 patients treated with DOA N= 130 treated with VKA

Criteria

Patient Eligibility

  1. a) Bleeding patients:

    Anticoagulated patients with DOA or VKA with clinically overt major bleeding according to a specified ISTH definition for non-surgical patients:

    • Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome
    • Bleeding causing a fall in hemoglobin level of 20 g L-1 (1.24 mmol L-1 ) or more leading to transfusion of two or more units of whole blood or red cells.

    OR b) Acute surgical need Patients treated with DOA or VKA and who need urgent operation which cannot wait (< 24 h after last intake of drug)

    AND

  2. with or without reversal agent use (e.g. PCC, aPCC, rVIIa) (and/or haemodialysis for dabigatran)

    AND

  3. provides informed consent after the acute event
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01722786

Contacts
Contact: Edelgard Lindhoff-Last, MD +49-6963015096 lindhoff-last@em.uni-frankfurt.de

Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
  More Information

No publications provided

Responsible Party: Prof. Dr. E. Lindhoff-Last, Division of Angiology, Department of Internal Medicine, Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier: NCT01722786     History of Changes
Other Study ID Numbers: RADOA-Registry
Study First Received: November 5, 2012
Last Updated: May 8, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Johann Wolfgang Goethe University Hospitals:
severe bleeding
dabigatran
rivaroxaban
apixaban
edoxaban
PCC
aPCC
rVIIa
hemodialysis

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014