Reversal Agent Use in Patients Treated With Direct Oral Anticoagulants or Vitamin K Antagonists (RADOA). Focus on New Antidots

NCT03537521 | Withdrawn DMC

• 1 other identifier: RADOA.DOT
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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; urgent surgery; andexanet alpha

Outcome Measures

Primary Outcomes (1)

• In hospital mortality up to 30 days after admission

  Death rate (number of deaths)

  up to 30 days after hospital admission

Secondary Outcomes (10)

• Stop of bleeding defined according to the treating physicians

  up to 30 days after hospital admission

• Fatality rate caused by unstoppable bleeding

  up to 30 days after hospital admission

• Use versus no use of reversal agents - difference in outcome?

  up to 30 days after hospital admission

• Definition of supportive measures being effective in stopping bleeding

  up to 30 days after hospital admission

• Effectiveness of dialysis vs. no dialysis in case of dabigatran accumulation associated with bleeding

  up to 30 days after hospital admission

Study Arms (2)

DOA

N= 130 patients treated with direct oral anticoagulants (DOAC) with acute bleeding N= 65 patients treated with direct oral anticoagulants (DOAC) with urgent surgical intervention

Procedure: Urgent surgery which can not be postponed to the next 24 hrs

VKA

N= 130 patients treated with vitamin K antagonists (VKA) with acute bleeding N= 65 patients treated with vitamin K antagonists (VKA) with urgent surgical intervention

Procedure: Urgent surgery which can not be postponed to the next 24 hrs

Interventions

Urgent surgery which can not be postponed to the next 24 hrs PROCEDURE

The urgent surgical intervention is not part of the registry protocol. The intervention is the acute event that leads to enrollment in the registry. It might be e.g. the surgical treatment of a trauma, fall, acute abdomen, appendicitis or anything else.

DOA; VKA

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= 130 patients treated with direct oral anticoagulants (DOA) with acute bleeding N= 130 treated with vitamin K antagonists (VKA) with acute bleeding N= 65 patients treated with direct oral anticoagulants (DOA) with urgent surgical intervention N= 65 patients treated with vitamin K antagonists (VKA) with urgent surgical intervention

You may qualify if:

• Group 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.
• Group 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)
• with or without reversal agent use (e.g. PCC, aPCC, rVIIa) (and/or haemodialysis for dabigatran)
• provides informed consent after the acute event

You may not qualify if:

• Age \< 18 years
• Concomitant participation in an interventional trial

Sponsors & Collaborators

• Cardioangiologisches Centrum Bethanien: lead

Related Publications (1)

• 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

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 Officials

• Edelgard Lindhoff-Last, Prof.

  CCB Studienzentrum GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2018
• First Posted: May 25, 2018
• Study Start: April 1, 2020
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2023
• Last Updated: July 17, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share