Severe BleedingRADOANCT01722786
Reversal Agent Use in Patients Treated With Direct Oral Anticoagulants or Vitamin K Antagonists
An observational study of Severe Bleeding and Urgent Surgery, run by Cardioangiologisches Centrum Bethanien at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Severe Bleeding, Urgent Surgery
- Type of treatment
- Pill or oral medicine
- How many people
- 272 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2014to 9 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
- 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
- with or without reversal agent use (e.g. PCC, aPCC, rVIIa) (and/or haemodialysis for dabigatran) AND
- provides informed consent after the acute event
Trial locations and contacts
1 site in 1 country.
About this study
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 or Vitamin K Antagonists
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.
Read the detailed description
The Registry will offer the opportunity to evaluate the effects of reversal agents as PCC, aPCC, rVIIa, specific antidots 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.
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
- 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).
- Conditions
- Severe Bleeding, Urgent Surgery
- Keywords
- severe bleeding, dabigatran, rivaroxaban, apixaban, edoxaban, PCC, aPCC, rVIIa, hemodialysis, antidots, idarucizumab
- Medical subject headings
- Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
- Stop of bleeding defined according to the treating physicians
- Fatality rate caused by unstoppable bleeding
- Use versus no use of reversal agents - difference in outcome?
- Definition of supportive measures being effective in stopping bleeding
- Effectiveness of specific antidots
- Effectiveness of dialysis vs. no dialysis in case of dabigatran accumulation associated with bleeding
- Causality assessment: Relation of SAE to anticoagulant medication
Measured: open
Secondary outcomes (1)
Secondary Outcome
Secondary observation points (group of patients with acute surgery under oral anticoagulation)
- Blood loss, number of transfusions necessary
- Satisfaction of surgeon during and after surgery concerning bleeding
- Use versus no use of reversal agents - difference in blood loss and number of transfusions?
- Use versus no use of reversal agents - difference in satisfaction of surgeon using a standardized questionnaire
- Causality assessment: Relation of SAE to anticoagulant medication
- Delay in performance of surgery due to anticoagulation
Measured: open
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2012 (estimated)
- Study startApr 2014
- Primary completion30 Jun 2018
- Study completion9 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Severe BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardioangiologisches Centrum Bethanien
- Sponsor type
- University, hospital or other
- Collaborators
- Johannes Gutenberg University Mainz, University Hospital Greifswald, University Hospital Dresden, University Hospital, Aachen, Goethe University, University Hospital Schleswig-Holstein, Vivantes Netzwerk für Gesundheit GmbH, Ruhr University of Bochum, Technische Universität Dresden, Städtisches Klinikum Dresden-Friedrichstadt
- Responsible party
- Principal investigator, Prof. Dr. med. E. Lindhoff-Last, Cardioangiologisches Centrum Bethanien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01722786
- Sponsor's protocol ID
- RADOA-Registry
- Acronym
- RADOA
- Status last verified
- Jul 2020
- First submitted
- 5 Nov 2012
- Last updated
- 16 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 32605708Pfeilschifter 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.
PubMed 35491419
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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 or Vitamin K Antagonists
- ClinicalTrials.gov ID
- NCT01722786
- Acronym / sponsor ID
- RADOA / RADOA-Registry
- Conditions
- Severe Bleeding, Urgent Surgery
- Keywords
- severe bleeding, dabigatran, rivaroxaban, apixaban, edoxaban, PCC, aPCC, rVIIa
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Cardioangiologisches Centrum BethanienUniversity, hospital or other
- Collaborators
- Johannes Gutenberg University Mainz, University Hospital Greifswald, University Hospital Dresden, University Hospital, Aachen, Goethe University, University Hospital Schleswig-Holstein, Vivantes Netzwerk für Gesundheit GmbH, Ruhr University of Bochum, Technische Universität Dresden, Städtisches Klinikum Dresden-Friedrichstadt
- Study start
- Apr 2014
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 9 Jul 2019 (actual)
- First posted
- 7 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The Registry will offer the opportunity to evaluate the effects of reversal agents as PCC, aPCC, rVIIa, specific antidots 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.
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
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary Outcome
Time frame: open
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
1 secondary outcome
Secondary Outcome
Time frame: open
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
- Background: PubMed 32605708Lindhoff-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.
- Derived from this study: PubMed 35491419Pfeilschifter 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.
- Individual participant dataSharing planned: No
Related trials for Severe Bleeding
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
Active, not recruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Factor IX Gene Therapy With PF-06838435 in Adult Males With Moderately Severe to Severe Hemophilia B
Hemophilia B
Active, not recruitingObservational study
Resumption of Anticoagulation After Major Gastrointestinal Bleeding in Patients With Atrial Fibrillation
Atrial Fibrillation (AF), Major Gastrointestinal Bleeding (MGIB)
RecruitingObservational study
Role of Viscoelastometric Testing in the Development and Validation of a Clinical-biological Score for Predicting Bleeding in Patients With Malignant Haematological Disorders and Severe Thrombocytopenia
Thrombocytopenia, Platelet Transfusion
Not yet recruitingObservational study
Post Approval Phase 4 Study to Learn More About How Safe Octocog Alfa is, and How Well it Works in Patients With Severe Hemophilia A in India
Severe Hemophilia A
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Bleeding and Urgent Surgery, run by Cardioangiologisches Centrum Bethanien at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome (time frame: open). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01722786, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2020.