Trial document





This trial has been registered retrospectively.
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  DRKS00011232

Trial Description

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Title

Interaction of coagulation FACtors, Thrombocytes and leukOcytes in patients with aRterial hypeRtension study

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Trial Acronym

FACTO-RR study

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URL of the Trial

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Brief Summary in Lay Language

Monocentric observational study on the interplay of coagulation factors, thrombocytes and leukocytes in patients with arterial hypertension

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Brief Summary in Scientific Language

We enrolled 71 all-comer patients with arterial hypertension admitted to either the outpatient clinic or the emergency room of the center for cardiology-cardiology I, University Medical Center Mainz into the “Interaction of coagulation FACtors, Thrombocytes and leukOcytes in patients with aRterial hypeRtension study” (FACTO-RR study). Inclusion criteria were age ≥18 years and history of essential arterial hypertension of at least 6 months. Exclusion criteria were age ≥90 years, anticoagulant therapy (unfractionated or low molecular weight heparin, vitamin K antagonist, FXa-inhibitors, thrombin inhibitors), acute coronary syndromes, exacerbated disease requiring critical care medicine (e.g. hypertensive crisis with pulmonary edema and respiratory failure) or immediate surgery (e.g., aortic dissection or rupture). The study protocol was approved by the local ethics committee of the state of Rhineland-Palatinate, Germany, reference number 837.354.12 (8455-F). Medical history was taken and body weight, height and heart rate were obtained. Office blood pressure was measured in each study participant in an upright sitting position (room temperature 22° centigrade) using the Omron 705CP-II (Omron) device and upper arm cuffs adapted to upper arm circumference (17-22 cm, 22-32 cm an 32-42 cm, respectively). Immediately after that, a maximum of 10ml of venous citrated blood was drawn from the cubital vein of the right arm to prepare platelet rich and platelet poor plasma, leukocyte preparations and to assess blood count.

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Organizational Data

  •   DRKS00011232
  •   2016/11/04
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  •   yes
  •   Approved
  •   837.354.12 (8455-F), Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
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Secondary IDs

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Health Condition or Problem studied

  •   I10 -  Essential (primary) hypertension
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Interventions/Observational Groups

  •   Controlled hypertension
    Directly after study enrolment, Medical history was taken and body weight, height and heart rate were obtained. Office blood pressure was measured in each study participant in an upright sitting position (room temperature 22° centigrade) using the Omron 705CP-II (Omron) device and upper arm cuffs adapted to upper arm circumference (17-22 cm, 22-32 cm an 32-42 cm, respectively). Immediately after that, a maximum of 10ml of venous citrated blood was drawn from the cubital vein of the right arm to prepare platelet rich and platelet poor plasma, leukocyte preparations and to assess blood count.
  •   Uncontrolled hypertension. Directly after study enrolment, Medical history was taken and body weight, height and heart rate were obtained. Office blood pressure was measured in each study participant in an upright sitting position (room temperature 22° centigrade) using the Omron 705CP-II (Omron) device and upper arm cuffs adapted to upper arm circumference (17-22 cm, 22-32 cm an 32-42 cm, respectively). Immediately after that, a maximum of 10ml of venous citrated blood was drawn from the cubital vein of the right arm to prepare platelet rich and platelet poor plasma, leukocyte preparations and to assess blood count.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Correlation of the severity of arterial hypertension with markers of activation of the coagulation system as well as thrombocyte and leukocyte (patho)physiology. Medical history was taken and body weight, height and heart rate were obtained. Office blood pressure was measured in each study participant in an upright sitting position (room temperature 22° centigrade) using the Omron 705CP-II (Omron) device and upper arm cuffs adapted to upper arm circumference (17-22 cm, 22-32 cm an 32-42 cm, respectively). Immediately after that, a maximum of 10ml of venous citrated blood was drawn from the cubital vein of the right arm to prepare platelet rich and platelet poor plasma, leukocyte preparations and to assess blood count.

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Secondary Outcome

N/A

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2014/08/20
  •   71
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   90   Years
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Additional Inclusion Criteria

essential arterial hypertension

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Exclusion Criteria

Age ≥90 years, anticoagulant therapy (unfractionated or low molecular weight heparin, vitamin K antagonist, FXa-inhibitors, thrombin inhibitors), acute coronary syndromes, exacerbated disease requiring critical care medicine (e.g. hypertensive crisis with pulmonary edema and respiratory failure) or immediate surgery (e.g., aortic dissection or rupture).

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Addresses

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    • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
    • Langenbeckstraße 1
    • 55131  Mainz
    • Germany
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    • Universitätsmedizin Mainz, Zentrum für Kardiologie - Kardiologie I
    • Mr.  Prof. Dr. med.  Philip  Wenzel 
    • Langenbeckstrasse 1
    • 55133  Mainz
    • Germany
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    • Universitätsmedizin Mainz, Zentrum für Kardiologie - Kardiologie I
    • Mr.  Prof. Dr. med.  Philip  Wenzel 
    • Langenbeckstrasse 1
    • 55133  Mainz
    • Germany
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Sources of Monetary or Material Support

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    • Bundesministerium für Bildung und Forschung Dienstsitz Berlin
    • Friedrichstraße 130 B
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.