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

Sponsor

Cardioangiologisches Centrum Bethanien (Other)

Overall Status

Withdrawn

CT.gov ID

NCT03537521

Collaborator

(none)

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Severe Bleeding Urgent Surgery	Procedure: Urgent surgery which can not be postponed to the next 24 hrs

Detailed Description

The Registry will offer the opportunity to evaluate the effects of reversal agents as PCC, aPCC, rVIIa, specific antidots in patients needing urgent interventions/operations or in 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.

The current objective of this registry is to:

Document the clinical course and outcome of various clinical bleeding events associated with DOA or VKA in patients with severe life-threatening bleeding making intervention necessary
Document the clinical course and outcome of urgent surgical interventions within 24 hours after admission in patients under DOA or VKA treatment.
Characterisation of therapeutic strategies in stopping acute life-threatening bleeding including following agents and methods:
blood transfusion,
platelet concentrates
reversal agents [e.g. vitamin K, prothrombin complex concentrate (PCC), activated PCC (aPCC), activated factor VII (aVII), fibrinogen concentrate, fresh frozen plasma (FFP)]
specific antidots, e.g. idarucizumab, Andexanet alpha
haemodialysis
desmopressin
tranexamic acid
no specific treatment in respect to the above mentioned treatments (e.g. stop of medication and waiting until anticoagulant effect of DOA is decreased).

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

0 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Prospective, Observational, Non-interventional Open-Label, International, Multicenter Registry Regarding the Management of Severe Bleeding and/or Urgent Interventions During Treatment With Direct Oral Anticoagulants or Vitamin K Antagonists

Anticipated Study Start Date :

Apr 1, 2020

Anticipated Primary Completion Date :

Apr 1, 2022

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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 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.
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 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.

Arm

Intervention/Treatment

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

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.

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

Outcome Measures

Primary Outcome Measures

In hospital mortality up to 30 days after admission [up to 30 days after hospital admission]
Death rate (number of deaths)

Secondary Outcome Measures

Stop of bleeding defined according to the treating physicians [up to 30 days after hospital admission]
Decission according to the treating physicians
Fatality rate caused by unstoppable bleeding [up to 30 days after hospital admission]
Death rate (number of deaths)
Use versus no use of reversal agents - difference in outcome? [up to 30 days after hospital admission]
documentation of use of reversal agents in eCRF
Definition of supportive measures being effective in stopping bleeding [up to 30 days after hospital admission]
documentation of supportive measures in eCRF
Effectiveness of dialysis vs. no dialysis in case of dabigatran accumulation associated with bleeding [up to 30 days after hospital admission]
time frame until stop of bleeding
Causality assessment: Relation of SAE to anticoagulant medication [up to 30 days after hospital admission]
Decission according to the treating physicians
Blood loss, number of transfusions necessary [up to 30 days after hospital admission]
documentation of supportive measures in eCRF
Satisfaction of surgeon during and after surgery concerning bleeding [up to 30 days after hospital admission]
Decission according to the treating physicians
Use versus no use of reversal agents - difference in blood loss and number of transfusions [up to 30 days after hospital admission]
documentation of supportive measures in eCRF
Delay in performance of surgery due to anticoagulation [up to 30 days after hospital admission]
time Frame documented in eCRF

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 99 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria for Group a and b:

Conscious patient by him-/ herself or his/ her available legal representative does not agree with inclusion in the registry
Age < 18 years
Concomitant participation in an interventional trial