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Thrombus Formation Under Different Flow-conditions

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Maastricht University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Netherlands Heart Foundation
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01114074
First received: April 12, 2010
Last updated: August 25, 2011
Last verified: August 2011
  Purpose

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.


Condition
Thrombosis

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: The Influence of the Proteins of the Contact Activation System on Thrombus Formation Under Different Flow-conditions in Blood

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Thrombus formation, stability and break down [ Time Frame: Up to 36 months ] [ Designated as safety issue: No ]
    Using perfusion-flow experiments the formation, stability and break down of clots formed from the blood of the study participants will be determined.


Biospecimen Retention:   Samples Without DNA
  • Whole blood
  • Platelet poor plasma

Estimated Enrollment: 46
Study Start Date: May 2011
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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

Criteria

Inclusion Criteria:

  • Patient group:
  • Age: ≥ 18 years
  • Deficiency in factor XII, factor XI, prekallikrein or high molecular weight kininogen
  • Control group:
  • Age: ≥ 18 years

Exclusion Criteria:

  • (Other) Coagulation defects
  • Symptoms of active disease
  • The use of antiplatelet drugs
  • The use of aspirin/ascal
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01114074

Contacts
Contact: Joke Konings, MSc +31-433881542 J.Konings@maastrichtuniversity.nl
Contact: José WP Govers-Riemslag, PhD +31-433884263 J.Govers@maastrichtuniversity.nl

Locations
Netherlands
Maastricht University Recruiting
Maastricht, Limburg, Netherlands, 6229 ER
Contact: Joke Konings, MSc    +31-433881542    J.Konings@BIOCH.unimaas.nl   
Contact: José WP Govers-Riemslag, PhD    +31-433884263    J.Govers@BIOCH.unimaas.nl   
Principal Investigator: Joke Konings, MSc         
Sponsors and Collaborators
Maastricht University Medical Center
Netherlands Heart Foundation
Investigators
Principal Investigator: Hugo Ten Cate, MD, PhD Maastricht University Medical Centre
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01114074     History of Changes
Other Study ID Numbers: 10-3-015, #2008B120
Study First Received: April 12, 2010
Last Updated: August 25, 2011
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Thrombosis
Blood coagulation
Perfusion flow experiments
Factor XII
Factor XI
Prekallikrein
High molecular weight kininogen

Additional relevant MeSH terms:
Thrombosis
Cardiovascular Diseases
Embolism and Thrombosis
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014