Bleeding complications after cardiac treatment
| ISRCTN | ISRCTN16732094 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16732094 |
- Submission date
- 01/01/2024
- Registration date
- 05/01/2024
- Last edited
- 05/01/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
The project assumes broadening of knowledge among patients hospitalized in non-cardiac departments who receive treatment that increases the risk of bleeding, determining the factors affecting this risk and optimizing the diagnostic and therapeutic process among these patients.
There are currently no extensive analyzes of bleeding complications in non-cardiology departments, the publications that will be created on the basis of the collected database will supplement the missing knowledge in the field of planning anticoagulant and/or antiplatelet treatment and management of complications of the above therapy. The endpoints can also be used to create guidelines and various expert positions.
Who can participate?
Patients receiving anticoagulant and/or antiplatelet therapy hospitalized in non-cardiac departments with a complication of treatment in the form of bleeding.
What does the study involve?
Our study is a prospective, multicenter, registry study. We plan to invite several centers to the register, including several departments with different profiles - including surgical and non-surgical ones (neurology, urology, gastroenterology, surgery, otolaryngology, gynecology etc.) We are focusing on patients who are receiving antiplatelet and/or anticoagulant therapy with bleeding complications. The study population will be characterized according to the type of received treatment and also the type of bleeding. We plan to collect data for about 2 years with 1 month and 1 year follow-up after hospitalization.
What are the possible benefits and risks of participating?
None
Where is the study run from?
MezzoCardio (Poland)
When is the study starting and how long is it expected to run for?
September 2021 to December 2025
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Maciej Kocjan, maciej.kocjan@sum.edu.pl
Prof Damian Kawecki, damian.kawecki@sum.edu.pl
Contact information
Public, Scientific, Principal Investigator
Sklodowskiej-Curie 10
Zabrze
41-800
Poland
 ORCID ID |
0000-0003-4445-9721 |
|---|---|
| Phone | +48 720813983 |
| damian.kawecki@sum.edu.pl |
Study information
| Study design | Multicenter registry study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Home, Hospital, Laboratory, Medical and other records, Telephone |
| Study type | Diagnostic, Prevention, Quality of life, Screening, Treatment, Safety, Efficacy |
| Participant information sheet | To follow |
| Scientific title | BLEEDing complications After Cardiac Treatment - BLEED-ACT Registry |
| Study acronym | BLEED-ACT |
| Study objectives | The project assumes broadening of knowledge among patients hospitalized in non-cardiac departments who receive treatment that increases the risk of bleeding, determining the factors affecting this risk and optimizing the diagnostic and therapeutic process among these patients. |
| Ethics approval(s) | Ethics approval not required |
| Ethics approval additional information | Our trial is a study of patient data, not an experiment so it does not require an ethics approval. We have received an opinion of the bioethical committee on this matter - no. PCN/CBN/0022/KB/239/21 |
| Health condition(s) or problem(s) studied | Patients who are receiving antiplatelet and/or anticoagulant therapy with bleeding complications. |
| Intervention | Our study is a prospective, multicenter, registry study. We plan to invite several centers to the register, including several departments with different profiles - including surgical and non-surgical ones. We will collect data on risk factors, etiology, diagnostics, management and prognosis in patients with bleeding complications. Data will be collected for 24 months with one year of prospective observation. Patients over 18 years of age will be eligible for the study. Exclusion criterion - lack of consent to participate in the register. |
| Intervention type | Other |
| Primary outcome measure | Basic clinical data on risk factors collected upon admission to hospital, upon discharge and one month after hospitalization: 1. Cardiovascular risk 2. Risk of bleeding 3. Thrombosis 4. Multi-morbidity 5. Indications and method of cardiac treatment (antiplatelet/anticoagulation) 6. Management of a patient undergoing cardiological treatment under planned conditions in the surgical ward 7. Leading symptoms of bleeding, location and degree of bleeding assessed based on the international BARC scale 8. In-hospital diagnostics 9. Management of bleeding 10. Length of hospitalization 11. Possible change of cardiac treatment after bleeding and prognosis in patients with bleeding complications |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/09/2021 |
| Completion date | 31/12/2025 |
Eligibility
| Participant type(s) | Patient, Population |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1000 |
| Key inclusion criteria | 1. Age over 18 years 2. Gender – women and men 3. Patients receiving anticoagulant and/or antiplatelet therapy hospitalized in non-cardiac departments with a complication of treatment in the form of bleeding. |
| Key exclusion criteria | 1. Age under 18 years of age 2. Lack of consent to participate in the register |
| Date of first enrolment | 01/01/2024 |
| Date of final enrolment | 30/11/2025 |
Locations
Countries of recruitment
- Poland
Study participating centre
Zabrze
41-800
Poland
Sponsor information
Other
Stefana Okrzei 1B
Tarnowskie Góry
42-600
Poland
| Phone | +48 720813983 |
|---|---|
| rejestracja@mezzocardio.pl |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 31/12/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication |
Editorial Notes
05/01/2024: Trial's existence confirmed by Polish Cardiological Society
