Hemophilia AGHMHWNCT02061033
Global Hemostatic Methods in Hemophilia and Von Willebrand's Disease
An observational study of Hemophilia A and Hemophilia B, run by Karolinska University Hospital at 1 site in Sweden.
Trial summary
Patients with hemophilia who have the same level of deficient factor(s) may express different severity of clinical presentation and bleeding tendency. Therefore a test which could determine overall hemostasis rather than simple concentration of a single deficient factor may correlate better with clinical phenotype in… Read more about this study
- Who is it for?
- Ages 10 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hemophilia A, Hemophilia B, Von Willebrand's Disease
- How many people
- 180 participants
- Where
- 1 siteSweden
- Study dates
- Mar 2013to Dec 2018
- 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 10 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 100 patients with moderate and severe hA, 30 patients with moderate and severe hB and 50 patients with VWD (primarily severe type I and type III) from hemophilia centers Stockholm, Sweden and Belgrade, Serbia.
Who may be able to join
- patients with bleeding disorders
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: GLOBAL HEMOSTATIC METHODS IN HEMOPHILIA AND VON WILLEBRAND'S DISEASE CORRELATION WITH PATIENTS' CLINICAL STATUS AND USEFULNESS FOR TREATMENT MONITORING
Patients with hemophilia who have the same level of deficient factor(s) may express different severity of clinical presentation and bleeding tendency. Therefore a test which could determine overall hemostasis rather than simple concentration of a single deficient factor may correlate better with clinical phenotype in these patients.
The investigators will therefore study the usefulness of global hemostatic methods (endogenous thrombin potential (ETP), overall hemostatic potential (OHP), fibrin clot structure) and microparticles in the prediction of severity of bleeding and estimation of response to the treatment in patients with hemophilia.
Read more
Since hemophilia patients on prophylactic treatment virtually do not bleed, additional patients who are treated on demand only will be included enabling to study possible modulatory effects of different hemostatic factors (particularly prothrombotic and thrombin activatable fibrinolysis inhibitor (TAFI)) on clinical presentation. The investigators will correlate both those factors and clinical severity with global hemostatic methods.
The investigators expect to prove that individual tailoring of the treatment, which may enable lowering the prophylactic dose of factor concentrate without increasing the risk of bleeding, is justified in some hemophilia patients. This approach would reduce the amount of necessary factor concentrate in certain patients and decrease the cost (which represents extensive burden for health care systems) of treatment without potential risk for the patients.
- Conditions
- Hemophilia A, Hemophilia B, Von Willebrand's Disease
- Keywords
- Hemophilia A, Hemophilia B, Von Willebrand's Disease, Endogen thrombin potential, Overall hemostatic potential, Microparticles, Fibrin clot
- Medical subject headings
- Hemophilia A, Hemophilia B, von Willebrand Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of microparticles
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startMar 2013
- Primary completionDec 2017 (estimated)
- Study completionDec 2018 (estimated)
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 Hemophilia AStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Society of Medicine, Karolinska Institutet
- Responsible party
- Principal investigator, Jovan P. Antovic MD, PhD, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061033
- Sponsor's protocol ID
- GHMJA2014
- Acronym
- GHMHW
- Status last verified
- Aug 2016
- First submitted
- 7 Feb 2014
- Last updated
- 31 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Antovic JP, Mikovic D, Elezovic I, Holmstrom M, Wilkens M, Elfvinge P, Mahmoud Hourani Soutari N, Antovic A. Two global haemostatic assays as additional tools to monitor treatment in cases of haemophilia A. Thromb Haemost. 2012 Jul;108(1):21-31. doi: 10.1160/TH11-11-0811. Epub 2012 Apr 26.
PubMed 22534727Mobarrez F, Mikovic D, Antovic A, Antovic JP. Is a decrease of microparticles related to improvement of hemostasis after FVIII injection in hemophilia A patients treated on demand? J Thromb Haemost. 2013 Apr;11(4):697-703. doi: 10.1111/jth.12103.
PubMed 23231463
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GLOBAL HEMOSTATIC METHODS IN HEMOPHILIA AND VON WILLEBRAND'S DISEASE CORRELATION WITH PATIENTS' CLINICAL STATUS AND USEFULNESS FOR TREATMENT MONITORING
- ClinicalTrials.gov ID
- NCT02061033
- Acronym / sponsor ID
- GHMHW / GHMJA2014
- Conditions
- Hemophilia A, Hemophilia B, Von Willebrand's Disease
- Keywords
- Hemophilia A, Hemophilia B, Von Willebrand's Disease, Endogen thrombin potential, Overall hemostatic potential, Microparticles, Fibrin clot
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- The Swedish Society of Medicine, Karolinska Institutet
- Study start
- Mar 2013
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 12 Feb 2014 (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 with hemophilia who have the same level of deficient factor(s) may express different severity of clinical presentation and bleeding tendency. Therefore a test which could determine overall hemostasis rather than simple concentration of a single deficient factor may correlate better with clinical phenotype in these patients.
The investigators will therefore study the usefulness of global hemostatic methods (endogenous thrombin potential (ETP), overall hemostatic potential (OHP), fibrin clot structure) and microparticles in the prediction of severity of bleeding and estimation of response to the treatment in patients with hemophilia.
Since hemophilia patients on prophylactic treatment virtually do not bleed, additional patients who are treated on demand only will be included enabling to study possible modulatory effects of different hemostatic factors (particularly prothrombotic and thrombin activatable fibrinolysis inhibitor (TAFI)) on clinical presentation. The investigators will correlate both those factors and clinical severity with global hemostatic methods.
The investigators expect to prove that individual tailoring of the treatment, which may enable lowering the prophylactic dose of factor concentrate without increasing the risk of bleeding, is justified in some hemophilia patients. This approach would reduce the amount of necessary factor concentrate in certain patients and decrease the cost (which represents extensive burden for health care systems) of treatment without potential risk for the patients.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 100 patients with moderate and severe hA, 30 patients with moderate and severe hB and 50 patients with VWD (primarily severe type I and type III) from hemophilia centers Stockholm, Sweden and Belgrade, Serbia.
Key inclusion criteria (1 listed)
- patients with bleeding disorders
Key exclusion criteria (1 listed)
- none
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
Number of microparticles
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2016.
- Results publication: PubMed 22534727Antovic JP, Mikovic D, Elezovic I, Holmstrom M, Wilkens M, Elfvinge P, Mahmoud Hourani Soutari N, Antovic A. Two global haemostatic assays as additional tools to monitor treatment in cases of haemophilia A. Thromb Haemost. 2012 Jul;108(1):21-31. doi: 10.1160/TH11-11-0811. Epub 2012 Apr 26.
- Results publication: PubMed 23231463Mobarrez F, Mikovic D, Antovic A, Antovic JP. Is a decrease of microparticles related to improvement of hemostasis after FVIII injection in hemophilia A patients treated on demand? J Thromb Haemost. 2013 Apr;11(4):697-703. doi: 10.1111/jth.12103.
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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.
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 Hemophilia A and Hemophilia B, run by Karolinska University Hospital at 1 site in Sweden.
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 1 inclusion and 1 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 31 Aug 2016. 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 Sweden. 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 Jovan P Antovic, MD, PhD (+46 734 294447, Jovan.Antovic@ki.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of microparticles (time frame: 5 years). 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 NCT02061033, 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 31 Aug 2016.