ThrombosisNCT01114074
Thrombus Formation Under Different Flow-conditions
An observational study of Thrombosis, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Rationale: Cardiovascular diseases are important causes of morbidity and mortality in the industrialized world. Clinical studies indicate an important role for the proteins of the contact activation system (coagulation factor XII (FXII), FXI, prekallikrein and high molecular weight kininogen (HMWK)) on the risk of… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Thrombosis
- How many people
- 46 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2011to Apr 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients: Patients with a congenital factor XII-deficiency Patients with a congenital factor XI-deficiency Patients with a congenital prekallikrein-deficiency Patients with a congenital high molecular weight kininogen-deficiency Controls: Healthy individuals without any coagulation defects
Who may be able to join
- Patient group:
- Age: ≥ 18 years
- Deficiency in factor XII, factor XI, prekallikrein or high molecular weight kininogen
- Control group:
- Age: ≥ 18 years
Who cannot join
- (Other) Coagulation defects
- Symptoms of active disease
- The use of antiplatelet drugs
- The use of aspirin/ascal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of the Proteins of the Contact Activation System on Thrombus Formation Under Different Flow-conditions in Blood
Rationale: Cardiovascular diseases are important causes of morbidity and mortality in the industrialized world. Clinical studies indicate an important role for the proteins of the contact activation system (coagulation factor XII (FXII), FXI, prekallikrein and high molecular weight kininogen (HMWK)) on the risk of cardiovascular disease. There is substantial evidence from mouse studies that FXII and FXI participate in the formation and stability of thrombi and in vitro studies showed that collagen is able to activate FXII and hereby stimulate thrombin formation and potentiate the formation of platelet-fibrin thrombi. The investigators want to determine the role of the proteins of the contact activation system in platelet mediated thrombus formation in human blood.
Objective: The investigators will study the effects of the proteins of the contact activation system on platelet mediated thrombus formation, embolization and degradation on collagen in a perfusion flow model.
Read more
Study design: Blood will be collected from human volunteers via a venipuncture in the forearm. Each volunteer will donate maximally four times 30 ml of blood over a period of two days. This blood is used in perfusion flow experiments: blood flows over a coverslip covered with collagen in a flow chamber. The investigators will vary several conditions such as the concentration of the proteins and the shear rate. For perfusion flow experiments, the investigators need fresh whole blood because platelets are viable for four hours. After this time, new blood is needed.
Study population: For this study the investigators need blood from human volunteers with a coagulation defect in one of the proteins of the contact activation system, e.g. FXII, FXI, prekallikrein or HMWK and controls without any coagulation defects.
Main study parameters/endpoints: The investigators main study endpoint is the ex vivo formation of platelet-mediated thrombi on collagen in a perfusion flow model. The investigators hypothesize that thrombi formed from blood of patients deficient in FXII or FXI are less stable than those formed from blood from controls.
- Conditions
- Thrombosis
- Keywords
- Thrombosis, Blood coagulation, Perfusion flow experiments, Factor XII, Factor XI, Prekallikrein, High molecular weight kininogen
- Medical subject headings
- Thrombosis
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 |
|---|---|---|
| Factor XII deficiency | Patients deficient in coagulation factor XII | |
| Factor XI Deficiency | Patients deficient in coagulation factor XI | |
| Prekallikrein deficiency | Patients deficient in prekallikrein | |
| HMWK deficiency | Patients deficient in high molecular weight kininogen (HMWK) | |
| Control group | Healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombus formation, stability and break down
Using perfusion-flow experiments the formation, stability and break down of clots formed from the blood of the study participants will be determined.
Measured: Up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2010 (estimated)
- Study startMay 2011
- Primary completionDec 2016 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies 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
- Time perspective
- Cross-sectional
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Netherlands Heart Foundation
- Responsible party
- Sponsor
- Investigators
- Hugo Ten Cate, MD, PhD, Principal investigator, Maastricht University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01114074
- Sponsor's protocol ID
- 10-3-015
- Other IDs
- #2008B120
- Status last verified
- Sep 2016
- First submitted
- 12 Apr 2010
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 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 Under Different Flow-conditions in Blood
- ClinicalTrials.gov ID
- NCT01114074
- Acronym / sponsor ID
- 10-3-015
- Conditions
- Thrombosis
- Keywords
- Thrombosis, Blood coagulation, Perfusion flow experiments, Factor XII, Factor XI, Prekallikrein, High molecular weight kininogen
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Netherlands Heart Foundation
- Study start
- May 2011
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 30 Apr 2010 (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.
Rationale: Cardiovascular diseases are important causes of morbidity and mortality in the industrialized world. Clinical studies indicate an important role for the proteins of the contact activation system (coagulation factor XII (FXII), FXI, prekallikrein and high molecular weight kininogen (HMWK)) on the risk of cardiovascular disease. There is substantial evidence from mouse studies that FXII and FXI participate in the formation and stability of thrombi and in vitro studies showed that collagen is able to activate FXII and hereby stimulate thrombin formation and potentiate the formation of platelet-fibrin thrombi. The investigators want to determine the role of the proteins of the contact activation system in platelet mediated thrombus formation in human blood.
Objective: The investigators will study the effects of the proteins of the contact activation system on platelet mediated thrombus formation, embolization and degradation on collagen in a perfusion flow model.
Study design: Blood will be collected from human volunteers via a venipuncture in the forearm. Each volunteer will donate maximally four times 30 ml of blood over a period of two days. This blood is used in perfusion flow experiments: blood flows over a coverslip covered with collagen in a flow chamber. The investigators will vary several conditions such as the concentration of the proteins and the shear rate. For perfusion flow experiments, the investigators need fresh whole blood because platelets are viable for four hours. After this time, new blood is needed.
Study population: For this study the investigators need blood from human volunteers with a coagulation defect in one of the proteins of the contact activation system, e.g. FXII, FXI, prekallikrein or HMWK and controls without any coagulation defects.
Main study parameters/endpoints: The investigators main study endpoint is the ex vivo formation of platelet-mediated thrombi on collagen in a perfusion flow model. The investigators hypothesize that thrombi formed from blood of patients deficient in FXII or FXI are less stable than those formed from blood from controls.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Factor XII deficiency | – | –Patients deficient in coagulation factor XII |
| Factor XI Deficiency | – | –Patients deficient in coagulation factor XI |
| Prekallikrein deficiency | – | –Patients deficient in prekallikrein |
| HMWK deficiency | – | –Patients deficient in high molecular weight kininogen (HMWK) |
| Control group | – | –Healthy controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients: Patients with a congenital factor XII-deficiency Patients with a congenital factor XI-deficiency Patients with a congenital prekallikrein-deficiency Patients with a congenital high molecular weight kininogen-deficiency Controls: Healthy individuals without any coagulation defects
Key inclusion criteria (5 listed)
- Patient group:
- Age: ≥ 18 years
- Deficiency in factor XII, factor XI, prekallikrein or high molecular weight kininogen
- Control group:
- Age: ≥ 18 years
Key exclusion criteria (4 listed)
- (Other) Coagulation defects
- Symptoms of active disease
- The use of antiplatelet drugs
- The use of aspirin/ascal
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
Thrombus formation, stability and break down
Time frame: Up to 36 months
Using perfusion-flow experiments the formation, stability and break down of clots formed from the blood of the study participants will be determined.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 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.
Hugo Ten Cate, MD, PhD principal investigator
Maastricht University Medical Centre
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 Thrombosis, run by Maastricht University Medical Center at 1 site in Netherlands.
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 4 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 Sep 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 Netherlands. 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?
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?
Thrombus formation, stability and break down (time frame: Up to 36 months). 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 13 Sep 2016.