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The Genetics and Functional Basis of Inherited Platelet, White Blood Cell, Red Blood Cell, and Blood Clotting Disorders.

StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Amendment history

  1. Minor

    Study Status

    Re-verified, no change to tracked fields

    v33

  2. Notable

    Primary and study completion dates: Jun 2024 to Jun 2030

    Study Statusv32

  3. Notable

    Primary and study completion dates: Jun 2023 to Jun 2024

    Study Statusv31

  4. Notable

    Primary and study completion dates: Jun 2022 to Jun 2023

    Study Statusv30

  5. Notable

    Primary and study completion dates: Jun 2021 to Jun 2022

    Study Statusv29

Show 27 earlier versions

  1. Minor

    Site contact updated

    Study Status, Contacts/Locationsv28

  2. Minor

    Eligibility criteria shortened, about 6 words

    Show what changed: Eligibility criteria
    Inclusion Criteria: A. Normal Healthy Volunteers (A): Normal healthy volunteers 18 years of age or older Either sex Any ethnic background. B. Patients with Glanzmann thrombasthenia or their relatives, inherited qualitative and/or quantitative platelet disorders, inherited disorders of white blood cells, inherited disorders of coagulation (including von Willebrand disease): Adults and children Either sex Any ethnic background Exclusion Criteria: A. Normal Healthy Volunteers (A): For studies of platelets that may be affected by anti-plat [...] donation would result in more than 2 donations in one week. [...]

    Study Status, Eligibilityv27

  3. Minor

    Eligibility criteria expanded, about 26 words

    Show what changed: Eligibility criteria
    Inclusion Criteria Normal Healthy Volunteers Inclusion criteria(A): Normal, healthy volunteers 18 years of age or older of either Either sex and any Any ethnic background. Exclusion criteriaCriteria Normal Healthy Volunteers (A): 1. For studies of platelets that may be affected by antiplateletanti-platelet therapy, ingestion of aspirin or similar medication in the past week. 2. Having given blood in the last 8 weeks such that the current [...] ation would exceed a total of 250 ml for the 8 week period. 3. Having given blood in the past week such that this donation would result in more than 2 donation [...] [...]

    Study Status, Eligibilityv26

  4. Minor

    Eligibility criteria shortened, about 31 words

    Show what changed: Eligibility criteria
    [...] B. Patients with Glanzmann thrombasthenia or their relatives, end stage renal disease, sickle cell disease or related disorders, inherited qualitative and/or quantitative platelet disorde [...] disorders of coagulation (including von Willebrand disease), and patients with diseases associated with increased intravascular shear forces (e.g., obstructive coronary disease, aortic stenosis, and coarctation of the aorta). Inclusion criteria: Adults and children of either sex and [...]

    Study Status, Arms and Interventions, Eligibilityv25

  5. Notable

    Trial status: Active, Not Recruiting to Recruiting

    Site details revised

    Study Status, Contacts/Locationsv24

  6. Minor

    Trial status: Recruiting to Active, Not Recruiting

    Site details revised

    Study Status, Contacts/Locationsv23

  7. Notable

    Primary and study completion dates: Jun 2020 to Jun 2021

    Study Statusv22

  8. Notable

    Primary and study completion dates: Jun 2019 to Jun 2020

    Study Statusv21

  9. Minor

    Study Status, Outcome Measures, References

    v20

  10. Minor

    Study Status

    Re-verified, no change to tracked fields

    v19

  11. Notable

    Primary and study completion dates: Jun 2016 to Jun 2019

    Study Statusv18

  12. Minor

    Primary and study completion dates: Dec 2015 to Jun 2016

    Study Statusv17

  13. Minor

    Collaborators expanded, about 7 words

    Show what changed: Collaborators
    National Heart, Lung, and Blood Institute (NHLBI)

    Study Identification, Study Status, Sponsor/Collaborators, Outcome Measuresv16

  14. Notable

    Primary and study completion dates: Dec 2013 to Dec 2015

    Study Identification, Study Status, Study Designv15

  15. Minor

    3 amendments

    3 re-verifications since 2012-08-08, no change to tracked fields

    v12-v14

  16. Notable

    Primary and study completion dates: Dec 2012 to Dec 2013

    Study Status, Sponsor/Collaboratorsv11

  17. Notable

    Primary and study completion dates: Dec 2009 to Dec 2012

    Study Identification, Study Statusv10

  18. Minor

    3 amendments

    3 re-verifications since 2009-11-11, no change to tracked fields

    v7-v9

  19. Minor

    Enrollment target: 60

    Primary and study completion dates: Dec 2009; Eligibility criteria expanded, about 260 words; Study title shortened, about 2 words

    Show what changed: Eligibility criteria
    Normal Volunteers Inclusion Criteriacriteria: Person withNormal, establishedhealthy volunteers 18 years of age or provisional diagnosisolder of platelet,either erythrocyte,sex leukocyte,and orany coagulationethnic disorderbackground. Exclusion Criteriacriteria: 1. HealthyFor peoplestudies of platelets that may be affected by antiplatelet therapy, ingestion of aspirin or similar medication in the past week. 2. Having given blood in the last 8 weeks such that the current donation would exceed a total of 250 ml for the 8 week period. 3. Having given blood in the past week such t [...]
    Show what changed: Study title
    Studies of theThe Genetics and Functional Basis of Inherited Platelet, White Blood Cell, Red Blood Cell, and Blood Clotting Disorders.

    Study Identification, Study Status, Sponsor/Collaborators, Oversight, Study Design, Arms and Interventions, Eligibilityv6

  20. Minor

    Study Status

    Re-verified, no change to tracked fields

    v5

  21. Minor

    Eligibility criteria shortened, about 1 word

    Study description expanded, about 52 words

    Show what changed: Eligibility criteria
    [...] platelet, erythrocyte, leukocyte, or coagulation disorder. - Exclusion Criteria: Healthy people
    Show what changed: Study description
    IndividualsAfter volunteers and family members agree to participate, they are evaluatedseen within the Outpatient Research Center by the Principal Investigator or another physician. A detailed history is obtained, a medical history, physical examination is performed, and laboratoryblood testingis obtained for further tests. Occasionally patients and family members are requested to establishreturn for additional tests. If an abnormality is identified with tests conducted in our research laboratory, we advise the volunteer to have the studies repeated in a diagnosis. Sampleslaboratory of DNA and [...] [...]

    Study Status, Study Description, Conditions, Eligibilityv4

  22. Minor

    2 amendments

    2 re-verifications since 2006-04-25, no change to tracked fields

    v2-v3

  1. Minor

    Study First Submitted

  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Blood contains red blood cells, white blood cells, and platelets, as well as a fluid portion termed plasma. We primarily study blood platelets, but sometimes we also analyze the blood of patients with red blood cell disorders (such as sickle cell disease), white blood cell disorders, and disorders of the blood clotting factors found in plasma. Blood platelets are small cell fragments that help people stop bleeding after blood vessels are damaged. Some individuals have abnormalities in their blood platelets that result in them not functioning properly. One such disorder is Glanzmann thrombasthenia. Most such patients have a bleeding disorder characterized by nosebleeds, gum bleeding, easy bruising (black and blue marks), heavy menstrual periods in women, and excessive bleeding after surgery or trauma. Our laboratory performs advanced tests of platelet function and platelet biochemistry. If we find evidence that a genetic disorder may be responsible, we analyze the genetic material (DNA and RNA) from the volunteer, and when possible, close family members to identify the precise defect.
Trial Details
NCT Number NCT00230165
Lead Sponsor Rockefeller University
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions Glanzmann Thrombasthenia
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov