Factor XI DeficiencyCONTACTNCT02785718
The Proteins of the Contact Activation System
A study testing Global Haemostasis assays in people with Factor XI Deficiency and Factor XII Deficiency, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Cardiovascular diseases are important causes of morbidity and mortality in the industrialized world. Abnormalities in the coagulation system, causing a hypercoagulable state, are a known risk factor for arterial and venous thrombosis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Factor XI Deficiency, Factor XII Deficiency
- What is being tested?
- Global Haemostasis assays
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2015to Sep 2016
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Deficiency in coagulation factor XII and factor XI (factor level<5%)
- Subjects of both gender
- Age ≥18 and ≤ 65
- Written informed consent from the subject
- Subject with a social security plan or beneficiary of such a plan.
Who cannot join
- Age below 18
- Age above 65
- Other known abnormalities of the coagulation system
- Thrombocytopenia
- Known platelet disorders
- Personal history of severe liver diseases
Show all 12Show fewer
- Symptoms of active disease (e.g. cancer)
- The use of antiplatelet drugs
- The use of drugs that interfere with coagulation
- Ongoing diagnosed pregnancy upper 3 months
- Adult patients protected by law
- Concomitant participation to a biomedical research
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Unité d'Hémostase Clinique Hôpital Louis Pradel
Bron, 69500
Yesim Dargaud, MD, PhD, (0)4 72 11 88 25 ext. +33, ydargaud@univ-lyon1.fr
Yesim Dargaud, MD, PhD
About this study
Official title: The Influence of the Proteins of the Contact Activation System on Thrombus Formation in Human Blood
Cardiovascular diseases are important causes of morbidity and mortality in the industrialized world. Abnormalities in the coagulation system, causing a hypercoagulable state, are a known risk factor for arterial and venous thrombosis. The contact activation system is part of the coagulation system and consists of four proteins: coagulation factor XII (FXII), FXI, prekallikrein and high molecular weight kininogen (HMWK). Clinical studies indicate an important role for the contact activation system on the risk of arterial thrombosis. Furthermore, there is substantial evidence from mouse studies that FXII and FXI participate in the formation and stability of thrombi. In vitro studies show that collagen, present in the vascular wall, is able to activate FXII and hereby stimulate thrombin formation and potentiate the formation of platelet-fibrin thrombi and FXIIa is able to change the structure of fibrin clots by binding to fibrin(ogen) and by generation of additional thrombin. However, the contact system also participates in the process of fibrinolysis, which degrades thrombi.
The investigators would like to investigate the contribution of the contact activation system to the formation of thrombi. The formation of a thrombus within the vascular bed is the main cause for occlusion of an artery or vein, which can lead to an infarct such as a heart attack. Due to the other functions of the contact system it is important to fully understand how the contact system contributes to thrombus formation, before it can be used as a target in the treatment of arterial thrombosis. The aim of this study is to determine the contribution of the proteins of the contact system, mainly FXII and FXI, in the platelet mediated formation and degradation of thrombi. This will be studied in flow models (perfusion-flow model and Chandler loop), in a static model (ROTEM®) and using thrombin generation assay.
- Conditions
- Factor XI Deficiency, Factor XII Deficiency
- Being tested
- Global Haemostasis assays
- Keywords
- Contact system, Factor XI deficiency, Factor XII deficiency, Global haemostasis assays
- Medical subject headings
- Factor XI Deficiency, Factor XII Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Global Haemostasis assaysOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with FXI or FXII deficiency | Experimental | 12 patients with FXI deficiency and 6 patients with FXII deficiency Receives: Other: Global Haemostasis assays |
What is being measured
The primary outcome is the main question the study is designed to answer.
fibrinolytic degradation rate of the formed clots by ROTEM analysis
Measured: 1 day (cross sectional)
Secondary outcomes (3)
the ex-vivo formation of platelet-mediated thrombi on collagen in a perfusion flow mode
Measured: 1 day (cross sectional)
biochemical composition of the thrombi formed in the Chandler loop
Measured: 1 day (cross sectional)
endogenous thrombin potential (ETP) of the platelet rich plasma of these patients
Measured: 1 day (cross sectional)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2016 (estimated)
- Study startJun 2015
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Factor XI DeficiencyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785718
- Sponsor's protocol ID
- 2012.785
- Acronym
- CONTACT
- Status last verified
- May 2016
- First submitted
- 25 May 2016
- Last updated
- 1 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of the Proteins of the Contact Activation System on Thrombus Formation in Human Blood
- ClinicalTrials.gov ID
- NCT02785718
- Acronym / sponsor ID
- CONTACT / 2012.785
- Conditions
- Factor XI Deficiency, Factor XII Deficiency
- Keywords
- Contact system, Factor XI deficiency, Factor XII deficiency, Global haemostasis assays
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 30 May 2016 (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.
Cardiovascular diseases are important causes of morbidity and mortality in the industrialized world. Abnormalities in the coagulation system, causing a hypercoagulable state, are a known risk factor for arterial and venous thrombosis. The contact activation system is part of the coagulation system and consists of four proteins: coagulation factor XII (FXII), FXI, prekallikrein and high molecular weight kininogen (HMWK). Clinical studies indicate an important role for the contact activation system on the risk of arterial thrombosis. Furthermore, there is substantial evidence from mouse studies that FXII and FXI participate in the formation and stability of thrombi. In vitro studies show that collagen, present in the vascular wall, is able to activate FXII and hereby stimulate thrombin formation and potentiate the formation of platelet-fibrin thrombi and FXIIa is able to change the structure of fibrin clots by binding to fibrin(ogen) and by generation of additional thrombin. However, the contact system also participates in the process of fibrinolysis, which degrades thrombi.
The investigators would like to investigate the contribution of the contact activation system to the formation of thrombi. The formation of a thrombus within the vascular bed is the main cause for occlusion of an artery or vein, which can lead to an infarct such as a heart attack. Due to the other functions of the contact system it is important to fully understand how the contact system contributes to thrombus formation, before it can be used as a target in the treatment of arterial thrombosis. The aim of this study is to determine the contribution of the proteins of the contact system, mainly FXII and FXI, in the platelet mediated formation and degradation of thrombi. This will be studied in flow models (perfusion-flow model and Chandler loop), in a static model (ROTEM®) and using thrombin generation assay.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with FXI or FXII deficiency | Experimental | Other: Global Haemostasis assays12 patients with FXI deficiency and 6 patients with FXII deficiency |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Deficiency in coagulation factor XII and factor XI (factor level<5%)
- Subjects of both gender
- Age ≥18 and ≤ 65
- Written informed consent from the subject
- Subject with a social security plan or beneficiary of such a plan.
Key exclusion criteria (12 listed)
- Age below 18
- Age above 65
- Other known abnormalities of the coagulation system
- Thrombocytopenia
- Known platelet disorders
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 |
|---|---|---|
| Global Haemostasis assays | Other | Patients with FXI or FXII deficiency |
Primary outcome
fibrinolytic degradation rate of the formed clots by ROTEM analysis
Time frame: 1 day (cross sectional)
3 secondary outcomes
the ex-vivo formation of platelet-mediated thrombi on collagen in a perfusion flow mode
Time frame: 1 day (cross sectional)
biochemical composition of the thrombi formed in the Chandler loop
Time frame: 1 day (cross sectional)
endogenous thrombin potential (ETP) of the platelet rich plasma of these patients
Time frame: 1 day (cross sectional)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2016.
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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?
A study testing Global Haemostasis assays in people with Factor XI Deficiency and Factor XII Deficiency, run by Hospices Civils de Lyon at 1 site in France.
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 5 inclusion and 12 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 1 Jun 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 France. 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 Yesim DARGAUD, MD PHD ((0)4 72 11 88 25 ext. +33, ydargaud@univ-lyon1.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fibrinolytic degradation rate of the formed clots by ROTEM analysis (time frame: 1 day (cross sectional)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2016.