Reversal Agent Use in Patients Treated With Direct Oral Anticoagulants or Vitamin K Antagonists

NCT01722786 | Completed DMC

• 1 other identifier: RADOA-Registry
• Study Type: observational
• Target: 272
• Locations: 1 country
• Sites: 1

Brief Summary

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, or during emergency operations.

Conditions

Severe Bleeding; Urgent Surgery

Keywords

severe bleeding; dabigatran; rivaroxaban; apixaban; edoxaban; PCC; aPCC; rVIIa; hemodialysis; antidots; idarucizumab

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  Primary observation points (for all patients): In hospital mortality up to 30 days after admission Secondary observation points (group of patients with life threatening bleeding under oral anticoagulation) 1. Stop of bleeding defined according to the treating physicians 2. Fatality rate caused by unstoppable bleeding 3. Use versus no use of reversal agents - difference in outcome? 4. Definition of supportive measures being effective in stopping bleeding 5. Effectiveness of specific antidots 6. Effectiveness of dialysis vs. no dialysis in case of dabigatran accumulation associated with bleeding 7. Causality assessment: Relation of SAE to anticoagulant medication

  open

Secondary Outcomes (1)

• Secondary Outcome

  open

Study Arms (2)

DOA

Expected number of patients estimated by study duration N= 90 patients treated with direct oral anticoagulants (DOA) with acute bleeding N= 40 patients treated with direct oral anticoagulants (DOA) with urgent surgical intervention

VKA

Expected number of patients estimated by study duration N= 90 treated with vitamin K antagonists (VKA) with acute bleeding N= 40 patients treated with vitamin K antagonists (VKA) with urgent surgical intervention

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Expected number of patients estimated by study duration N= 90 patients treated with direct oral anticoagulants (DOA) with acute bleeding N= 90 treated with vitamin K antagonists (VKA) with acute bleeding N= 40 patients treated with direct oral anticoagulants (DOA) with urgent surgical intervention N= 40 patients treated with vitamin K antagonists (VKA) with urgent surgical intervention

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 2 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cardioangiologisches Centrum Bethanien: lead
• Johannes Gutenberg University Mainz: collaborator
• University Hospital Greifswald: collaborator
• University Hospital Dresden: collaborator
• University Hospital, Aachen: collaborator
• Goethe University: collaborator
• University Hospital Schleswig-Holstein: collaborator
• Vivantes Netzwerk für Gesundheit GmbH: collaborator
• Ruhr University of Bochum: collaborator
• Technische Universität Dresden: collaborator
• Städtisches Klinikum Dresden-Friedrichstadt: collaborator

Study Sites (1)

Cardioangiology Center Bethanien (CCB)

Frankfurt am Main, 60389, Germany

Location

Related Publications (2)

• Lindhoff-Last E, Herrmann E, Lindau S, Konstantinides S, Grottke O, Nowak-Goettl U, Lucks J, Zydek B, Heymann CV, Birschmann I, Sumnig A, Beyer-Westendorf J, Schellong S, Meybohm P, Greinacher A. Severe Hemorrhage Associated With Oral Anticoagulants. Dtsch Arztebl Int. 2020 May 1;117(18):312-319. doi: 10.3238/arztebl.2020.0312.

  PMID: 32605708 BACKGROUND

• Pfeilschifter W, Lindhoff-Last E, Alhashim A, Zydek B, Lindau S, Konstantinides S, Grottke O, Nowak-Gottl U, von Heymann C, Birschmann I, Beyer-Westendorf J, Meybohm P, Greinacher A, Herrmann E; RADOA-Registry Investigators (Reversal Agent use in patients treated with Direct Oral Anticoagulants or vitamin K antagonists Registry). Intracranial bleeding under vitamin K antagonists or direct oral anticoagulants: results of the RADOA registry. Neurol Res Pract. 2022 May 2;4(1):16. doi: 10.1186/s42466-022-00183-y.

  PMID: 35491419 DERIVED

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.

MeSH Terms

Conditions

Hemorrhage

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: November 5, 2012
• First Posted: November 7, 2012
• Study Start: April 1, 2014
• Primary Completion: June 30, 2018
• Study Completion: July 9, 2019
• Last Updated: July 16, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)