Anticoagulant-induced BleedingAAIHINNNNCT06168838
Anticoagulant-associated Intracranial Hemorrhage
An observational study of Anticoagulant-induced Bleeding and Intracranial Hemorrhages, run by El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez at 1 site in Mexico.
Trial summary
Oral anticoagulant therapy, including factors Xa and 2a inhibitors has become more popular in recent years due to its efficacy and convenience in preventing thrombotic events and reducing the risk for stroke in patients with rosk factors (e.g. atrial fibrillation, deep venous thrombosis, pulmonary embolism). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anticoagulant-induced Bleeding, Intracranial Hemorrhages
- What is being tested?
- Anticoagulant
- Type of treatment
- Pill or oral medicine
- How many people
- 1,200 participants
- Where
- 1 siteMexico
- Study dates
- 9 Aug 2023to 31 Jan 2024
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All outpatients and/or hospitalized patients and patients from the emergency room of the National Institute of Neurology and Neurosurgery Manuel Velasco Suárez with intracranial hemorrhage diagnosis under anticoagulant therapy such as Vitamin K antangonists, Factor Xa inhibitors or direct thrombin inhibitors.
Who may be able to join
- Age >18 years
- Intracranial hemorrhage diagnosis and concomitant oral anticoagulant therapy
- Available clinical record from January 2015 to July 2023
Who cannot join
- Non available clinical record
- Patients that did not complete follow up on days 30 and 90 after an intracranial bleeding.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Instituto Nacional de Neurología y Neurocirugía
Mexico City, 14269
Claudia Vanessa Cano Nigenda, MD, +525556063822 ext. 14269, clinica-evc@innn.edu.mx
About this study
Official title: Anticoagulant-associated Intracranial Hemorrhage: Patient Characteristics and Outcomes From National Institute of Neurology and Neurosurgery Manuel Velasco: Single-Center Observational Study
Oral anticoagulant therapy, including factors Xa and 2a inhibitors has become more popular in recent years due to its efficacy and convenience in preventing thrombotic events and reducing the risk for stroke in patients with rosk factors (e.g. atrial fibrillation, deep venous thrombosis, pulmonary embolism). These drugs have replaced traditional therapies such as warfarin, which requires frequent dose adjustments and control blood samples. Warfarin also has a higher risk of bleeding events.
Many patients with atrial fibrillation, particularly old patients and those with comorbidities may have trouble achieving the dose and control requirements for warfarin therapy. On the other hand, Direct Oral Anticoagulant therapies do not require a close monitorization and have a lower risk of bleeding events, which makes them a more attractive option for many patients.
Read more
There is solid evidence behind the efficacy and safety of Direct Oral Anticoagulant therapies. Multiple clinical trials have demonstrated that Factor Xa inhibitors like rivaroxaban and apixaban are as effective as warfarin in preventing blood clots and reducing stroke risk in patients living with atrial fibrillation.
These challenges remark the need for new research that can improve our comprehension about the risk of bleeding associated to anticoagulant therapies and develop novel and more effective strategies for minimizing this risk.
Hence, an observational analysis about anticoagulant-associated intracranial hemorrhage may help identifying its incidence and prevalence, as well as treatment patterns and identifying any patient with risk factors linked to these events.
This information can be used to improve patient outcomes and guide future research.
Work Hypothesis: The majority of intracranial hemorrhage events are associated with heparin, low molecular weight heparin and warfarin instead of Factor Xa inhibitors or direct thrombin inhibitors. Nevertheless, the growing use in recent years of factor Xa inhibitors can increase the number of this therapy related bleeding events.
Read the detailed description
Study observational. The total number of subjects for this study will be determined by the number of patients with intracranial bleeding associated with anticoagulant therapy on the clinical records.
Primary objective: To identify the incidence and prevalence of intracranial bleeding events associated to oral anticoagulant therapy including vitamin k antagonists, factor Xa inhibitors and factor 2a inhibitors.
Secondary objective:
- To identify mortality related to intracranial bleeding associated with oral anticoagulant therapy, including vitamin K antagonists, factor Xa inhibitors and factor 2a inhibitors.
- To identify patients´ characteristics correlated with intracranial hemorrhage associated with oral anticoagulants.
- To identify treatment patterns: anticoagulant-associated intracranial bleeding management, including clinical, pharmacological, surgical, and interventional treatments, as well as procoagulant therapies.
Sample size Justification / Statistical Analysis: Non probabilistic, incidental reasoned selection.
The sample size will be determined by the number of patients with intracranial hemorrhage associated with anticoagulation in the clinical records. All electronic medical records that meet the inclusion criteria will be included in the analysis.
Descriptive analysis:
Descriptive statistics will be used for demographic and clinical characteristics of the study sample. This will include measures of central tendency (mean, median) and measures of dispersion (standard deviation, range).
Analytic (Inferential) analysis:
A univariate analysis will take place in order to examine the relationship between demographic and clinical variables with anticoagulation-associated intracranial hemorrhage This will include chi-squared tests for categorical data and T-tests or Mann-Whitney U Tests for continuous data.
A multivariable logistic regression analysis will be done to identify independent predictors of intracranial bleeding associated with anticoagulant therapy. The variables to include in the model will be determined by de univariate analysis results.
The investigators will consider a p-value under 0.05 for statistical significance.
- Being tested
- Anticoagulant
- Keywords
- Anticoagulants, Intracranial hemorrhage
- Medical subject headings
- Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnticoagulantDrug
Also called intracranial hemorrhage
Know the casuistry of spontaneous intracranial hemorrhages and secondary to the use of both oral and parenteral anticoagulants
What is being measured
The primary outcome is the main question the study is designed to answer.
Know incidence and prevalence of intracranial bleeding events
To identify the incidence and prevalence of intracranial bleeding events associated to oral anticoagulant therapy including vitamin k antagonists, factor Xa inhibitors and factor 2a inhibitors.
Measured: From January 2015 to November 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2023
- Study start9 Aug 2023
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Anticoagulant-induced 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Principal investigator, Vanessa Cano, El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez
- Investigators
- Claudia Vanessa Cano Nigenda, MD, Study director, Instituto Nacional de Neurología y Neurocirugía. Manuel Velasco Suárez
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06168838
- Sponsor's protocol ID
- INNN-DI-CI-271-2023
- Acronym
- AAIHINNN
- Status last verified
- Dec 2023
- First submitted
- 1 Sep 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Adachi T, Hoshino H, Takagi M, Fujioka S; Saiseikai Stroke Research Group. Volume and Characteristics of Intracerebral Hemorrhage with Direct Oral Anticoagulants in Comparison with Warfarin . Cerebrovasc Dis Extra. 2017;7(1):62-71. doi: 10.1159/000462985. Epub 2017 Apr 3.
PubMed 28376486Ballestri S, Romagnoli E, Arioli D, Coluccio V, Marrazzo A, Athanasiou A, Di Girolamo M, Cappi C, Marietta M, Capitelli M. Risk and Management of Bleeding Complications with Direct Oral Anticoagulants in Patients with Atrial Fibrillation and Venous Thromboembolism: a Narrative Review. Adv Ther. 2023 Jan;40(1):41-66. doi: 10.1007/s12325-022-02333-9. Epub 2022 Oct 16.
PubMed 36244055Barrios V, Cinza-Sanjurjo S, Gavin O, Egocheaga I, Burgos-Pol R, Soto J, Polanco C, Suarez J, Casado MA. Cost and burden of poor anticoagulation control with vitamin K antagonists in patients with nonvalvular atrial fibrillation in Spain. Rev Esp Cardiol (Engl Ed). 2021 Sep;74(9):773-780. doi: 10.1016/j.rec.2020.06.033. Epub 2020 Sep 24. English, Spanish.
PubMed 32980294Flaherty ML. Anticoagulant-associated intracerebral hemorrhage. Semin Neurol. 2010 Nov;30(5):565-72. doi: 10.1055/s-0030-1268866. Epub 2011 Jan 4.
PubMed 21207349Grysiewicz R, Gorelick PB. Incidence, mortality, and risk factors for oral anticoagulant-associated intracranial hemorrhage in patients with atrial fibrillation. J Stroke Cerebrovasc Dis. 2014 Nov-Dec;23(10):2479-2488. doi: 10.1016/j.jstrokecerebrovasdis.2014.06.031. Epub 2014 Oct 29.
PubMed 25440361Rozjabek HM, Coleman CI, Ashton V, Laliberte F, Oyefesobi P, Lejeune D, Germain G, Schein JR, Yuan Z, Lefebvre P, Peterson ED. Healthcare costs of stroke and major bleeding in patients with atrial fibrillation treated with non-vitamin K antagonist oral anticoagulants. J Med Econ. 2019 Aug;22(8):751-759. doi: 10.1080/13696998.2019.1603156. Epub 2019 Apr 25.
PubMed 30939954Hellenbart EL, Faulkenberg KD, Finks SW. Evaluation of bleeding in patients receiving direct oral anticoagulants. Vasc Health Risk Manag. 2017 Aug 23;13:325-342. doi: 10.2147/VHRM.S121661. eCollection 2017.
PubMed 28860793Izumi C, Miyake M, Amano M, Kitai T, Obayashi Y, Takegami M, Kimura T, Sugio K, Matsumoto T, Nishimura K, Furukawa Y. Registry of antithrombotic therapy in atrial fibrillation patients with bioprosthetic valves: A retrospective observational study. J Cardiol. 2020 Jul;76(1):44-50. doi: 10.1016/j.jjcc.2020.02.006. Epub 2020 Mar 7.
PubMed 32156512Lip GYH, Banerjee A, Boriani G, Chiang CE, Fargo R, Freedman B, Lane DA, Ruff CT, Turakhia M, Werring D, Patel S, Moores L. Antithrombotic Therapy for Atrial Fibrillation: CHEST Guideline and Expert Panel Report. Chest. 2018 Nov;154(5):1121-1201. doi: 10.1016/j.chest.2018.07.040. Epub 2018 Aug 22.
PubMed 30144419Milling TJ Jr, Frontera J. Exploring indications for the Use of direct oral anticoagulants and the associated risks of major bleeding. Am J Manag Care. 2017 Apr;23(4 Suppl):S67-S80.
PubMed 28581331Miyamoto S, Ikeda T, Ogawa S, Kitazono T, Nakagawara J, Minematsu K, Murakawa Y, Iwashiro S, Takeichi M, Kidani Y, Okayama Y, Sunaya T, Sato S, Yamanaka S. Clinical Risk Factors of Thromboembolic and Major Bleeding Events for Patients with Atrial Fibrillation Treated with Rivaroxaban in Japan. J Stroke Cerebrovasc Dis. 2020 Apr;29(4):104584. doi: 10.1016/j.jstrokecerebrovasdis.2019.104584. Epub 2020 Jan 23.
PubMed 31983518Qureshi AI, Mendelow AD, Hanley DF. Intracerebral haemorrhage. Lancet. 2009 May 9;373(9675):1632-44. doi: 10.1016/S0140-6736(09)60371-8.
PubMed 19427958Rohla M, Weiss TW, Pecen L, Patti G, Siller-Matula JM, Schnabel RB, Schilling R, Kotecha D, Lucerna M, Huber K, De Caterina R, Kirchhof P. Risk factors for thromboembolic and bleeding events in anticoagulated patients with atrial fibrillation: the prospective, multicentre observational PREvention oF thromboembolic events - European Registry in Atrial Fibrillation (PREFER in AF). BMJ Open. 2019 Mar 30;9(3):e022478. doi: 10.1136/bmjopen-2018-022478.
PubMed 30928922Roskell NS, Samuel M, Noack H, Monz BU. Major bleeding in patients with atrial fibrillation receiving vitamin K antagonists: a systematic review of randomized and observational studies. Europace. 2013 Jun;15(6):787-97. doi: 10.1093/europace/eut001. Epub 2013 Feb 13.
PubMed 23407628Ruiz-Sandoval JL, Chiquete E, Garate-Carrillo A, Ochoa-Guzman A, Arauz A, Leon-Jimenez C, Carrillo-Loza K, Murillo-Bonilla LM, Villarreal-Careaga J, Barinagarrementeria F, Cantu-Brito C; RENAMEVASC investigators. Spontaneous intracerebral hemorrhage in Mexico: results from a Multicenter Nationwide Hospital-based Registry on Cerebrovascular Disease (RENAMEVASC). Rev Neurol. 2011 Dec 16;53(12):705-12. English, Spanish.
PubMed 22127656
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anticoagulant-associated Intracranial Hemorrhage: Patient Characteristics and Outcomes From National Institute of Neurology and Neurosurgery Manuel Velasco: Single-Center Observational Study
- ClinicalTrials.gov ID
- NCT06168838
- Acronym / sponsor ID
- AAIHINNN / INNN-DI-CI-271-2023
- Keywords
- Anticoagulants, Intracranial hemorrhage
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco SuarezUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 9 Aug 2023 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 13 Dec 2023 (actual)
- 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.
Oral anticoagulant therapy, including factors Xa and 2a inhibitors has become more popular in recent years due to its efficacy and convenience in preventing thrombotic events and reducing the risk for stroke in patients with rosk factors (e.g. atrial fibrillation, deep venous thrombosis, pulmonary embolism). These drugs have replaced traditional therapies such as warfarin, which requires frequent dose adjustments and control blood samples. Warfarin also has a higher risk of bleeding events.
Many patients with atrial fibrillation, particularly old patients and those with comorbidities may have trouble achieving the dose and control requirements for warfarin therapy. On the other hand, Direct Oral Anticoagulant therapies do not require a close monitorization and have a lower risk of bleeding events, which makes them a more attractive option for many patients.
There is solid evidence behind the efficacy and safety of Direct Oral Anticoagulant therapies. Multiple clinical trials have demonstrated that Factor Xa inhibitors like rivaroxaban and apixaban are as effective as warfarin in preventing blood clots and reducing stroke risk in patients living with atrial fibrillation.
These challenges remark the need for new research that can improve our comprehension about the risk of bleeding associated to anticoagulant therapies and develop novel and more effective strategies for minimizing this risk.
Hence, an observational analysis about anticoagulant-associated intracranial hemorrhage may help identifying its incidence and prevalence, as well as treatment patterns and identifying any patient with risk factors linked to these events.
This information can be used to improve patient outcomes and guide future research.
Work Hypothesis: The majority of intracranial hemorrhage events are associated with heparin, low molecular weight heparin and warfarin instead of Factor Xa inhibitors or direct thrombin inhibitors. Nevertheless, the growing use in recent years of factor Xa inhibitors can increase the number of this therapy related bleeding events.
Detailed description
Study observational. The total number of subjects for this study will be determined by the number of patients with intracranial bleeding associated with anticoagulant therapy on the clinical records.
Primary objective: To identify the incidence and prevalence of intracranial bleeding events associated to oral anticoagulant therapy including vitamin k antagonists, factor Xa inhibitors and factor 2a inhibitors.
Secondary objective:
- To identify mortality related to intracranial bleeding associated with oral anticoagulant therapy, including vitamin K antagonists, factor Xa inhibitors and factor 2a inhibitors.
- To identify patients´ characteristics correlated with intracranial hemorrhage associated with oral anticoagulants.
- To identify treatment patterns: anticoagulant-associated intracranial bleeding management, including clinical, pharmacological, surgical, and interventional treatments, as well as procoagulant therapies.
Sample size Justification / Statistical Analysis: Non probabilistic, incidental reasoned selection.
The sample size will be determined by the number of patients with intracranial hemorrhage associated with anticoagulation in the clinical records. All electronic medical records that meet the inclusion criteria will be included in the analysis.
Descriptive analysis:
Descriptive statistics will be used for demographic and clinical characteristics of the study sample. This will include measures of central tendency (mean, median) and measures of dispersion (standard deviation, range).
Analytic (Inferential) analysis:
A univariate analysis will take place in order to examine the relationship between demographic and clinical variables with anticoagulation-associated intracranial hemorrhage This will include chi-squared tests for categorical data and T-tests or Mann-Whitney U Tests for continuous data.
A multivariable logistic regression analysis will be done to identify independent predictors of intracranial bleeding associated with anticoagulant therapy. The variables to include in the model will be determined by de univariate analysis results.
The investigators will consider a p-value under 0.05 for statistical significance.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All outpatients and/or hospitalized patients and patients from the emergency room of the National Institute of Neurology and Neurosurgery Manuel Velasco Suárez with intracranial hemorrhage diagnosis under anticoagulant therapy such as Vitamin K antangonists, Factor Xa inhibitors or direct thrombin inhibitors.
Key inclusion criteria (3 listed)
- Age >18 years
- Intracranial hemorrhage diagnosis and concomitant oral anticoagulant therapy
- Available clinical record from January 2015 to July 2023
Key exclusion criteria (2 listed)
- Non available clinical record
- Patients that did not complete follow up on days 30 and 90 after an intracranial bleeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AnticoagulantAlso: intracranial hemorrhageKnow the casuistry of spontaneous intracranial hemorrhages and secondary to the use of both oral and parenteral anticoagulants | Drug | – |
Primary outcome
Know incidence and prevalence of intracranial bleeding events
Time frame: From January 2015 to November 2023
To identify the incidence and prevalence of intracranial bleeding events associated to oral anticoagulant therapy including vitamin k antagonists, factor Xa inhibitors and factor 2a inhibitors.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
- Results publication: PubMed 28376486Adachi T, Hoshino H, Takagi M, Fujioka S; Saiseikai Stroke Research Group. Volume and Characteristics of Intracerebral Hemorrhage with Direct Oral Anticoagulants in Comparison with Warfarin . Cerebrovasc Dis Extra. 2017;7(1):62-71. doi: 10.1159/000462985. Epub 2017 Apr 3.
- Results publication: PubMed 36244055Ballestri S, Romagnoli E, Arioli D, Coluccio V, Marrazzo A, Athanasiou A, Di Girolamo M, Cappi C, Marietta M, Capitelli M. Risk and Management of Bleeding Complications with Direct Oral Anticoagulants in Patients with Atrial Fibrillation and Venous Thromboembolism: a Narrative Review. Adv Ther. 2023 Jan;40(1):41-66. doi: 10.1007/s12325-022-02333-9. Epub 2022 Oct 16.
- Results publication: PubMed 32980294Barrios V, Cinza-Sanjurjo S, Gavin O, Egocheaga I, Burgos-Pol R, Soto J, Polanco C, Suarez J, Casado MA. Cost and burden of poor anticoagulation control with vitamin K antagonists in patients with nonvalvular atrial fibrillation in Spain. Rev Esp Cardiol (Engl Ed). 2021 Sep;74(9):773-780. doi: 10.1016/j.rec.2020.06.033. Epub 2020 Sep 24. English, Spanish.
- Results publication: PubMed 21207349Flaherty ML. Anticoagulant-associated intracerebral hemorrhage. Semin Neurol. 2010 Nov;30(5):565-72. doi: 10.1055/s-0030-1268866. Epub 2011 Jan 4.
- Results publication: PubMed 25440361Grysiewicz R, Gorelick PB. Incidence, mortality, and risk factors for oral anticoagulant-associated intracranial hemorrhage in patients with atrial fibrillation. J Stroke Cerebrovasc Dis. 2014 Nov-Dec;23(10):2479-2488. doi: 10.1016/j.jstrokecerebrovasdis.2014.06.031. Epub 2014 Oct 29.
- Results publication: PubMed 30939954Rozjabek HM, Coleman CI, Ashton V, Laliberte F, Oyefesobi P, Lejeune D, Germain G, Schein JR, Yuan Z, Lefebvre P, Peterson ED. Healthcare costs of stroke and major bleeding in patients with atrial fibrillation treated with non-vitamin K antagonist oral anticoagulants. J Med Econ. 2019 Aug;22(8):751-759. doi: 10.1080/13696998.2019.1603156. Epub 2019 Apr 25.
- Results publication: PubMed 28860793Hellenbart EL, Faulkenberg KD, Finks SW. Evaluation of bleeding in patients receiving direct oral anticoagulants. Vasc Health Risk Manag. 2017 Aug 23;13:325-342. doi: 10.2147/VHRM.S121661. eCollection 2017.
- Results publication: PubMed 32156512Izumi C, Miyake M, Amano M, Kitai T, Obayashi Y, Takegami M, Kimura T, Sugio K, Matsumoto T, Nishimura K, Furukawa Y. Registry of antithrombotic therapy in atrial fibrillation patients with bioprosthetic valves: A retrospective observational study. J Cardiol. 2020 Jul;76(1):44-50. doi: 10.1016/j.jjcc.2020.02.006. Epub 2020 Mar 7.
- Results publication: PubMed 30144419Lip GYH, Banerjee A, Boriani G, Chiang CE, Fargo R, Freedman B, Lane DA, Ruff CT, Turakhia M, Werring D, Patel S, Moores L. Antithrombotic Therapy for Atrial Fibrillation: CHEST Guideline and Expert Panel Report. Chest. 2018 Nov;154(5):1121-1201. doi: 10.1016/j.chest.2018.07.040. Epub 2018 Aug 22.
- Results publication: PubMed 28581331Milling TJ Jr, Frontera J. Exploring indications for the Use of direct oral anticoagulants and the associated risks of major bleeding. Am J Manag Care. 2017 Apr;23(4 Suppl):S67-S80.
- Results publication: PubMed 31983518Miyamoto S, Ikeda T, Ogawa S, Kitazono T, Nakagawara J, Minematsu K, Murakawa Y, Iwashiro S, Takeichi M, Kidani Y, Okayama Y, Sunaya T, Sato S, Yamanaka S. Clinical Risk Factors of Thromboembolic and Major Bleeding Events for Patients with Atrial Fibrillation Treated with Rivaroxaban in Japan. J Stroke Cerebrovasc Dis. 2020 Apr;29(4):104584. doi: 10.1016/j.jstrokecerebrovasdis.2019.104584. Epub 2020 Jan 23.
- Results publication: PubMed 19427958Qureshi AI, Mendelow AD, Hanley DF. Intracerebral haemorrhage. Lancet. 2009 May 9;373(9675):1632-44. doi: 10.1016/S0140-6736(09)60371-8.
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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.
Claudia Vanessa Cano Nigenda, MD study director
Instituto Nacional de Neurología y Neurocirugía. Manuel Velasco Suárez
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 Anticoagulant-induced Bleeding and Intracranial Hemorrhages, run by El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. 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: status not confirmed, as of the sponsor's last update on 13 Dec 2023. 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 Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrés Alberto Mercado Pompa, MD (+525556063822 ext. 4466, clinica-evc@innn.edu.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Know incidence and prevalence of intracranial bleeding events (time frame: From January 2015 to November 2023). 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 NCT06168838, which also lists 17 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 13 Dec 2023.