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Usefulness of a Diagnostic Algorithm to Diagnose Thrombotic Microangiopathies in Pregnancy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03580941
Recruitment Status : Active, not recruiting
First Posted : July 10, 2018
Last Update Posted : July 10, 2018
Sponsor:
Collaborator:
Alexion Pharmaceuticals
Information provided by (Responsible Party):
Fundación Grupo de Investigación en Cuidados Intensivos y Obstetricia

Brief Summary:
Haemolytic uremic syndrome (HUS) is defined by the presence of the classic triad of non-immune microangiopathic hemolytic anemia (negative direct Coombs), thrombocytopenia and acute renal failure. Histological lesions of HUS are characterized by a systemic thrombotic microangiopathy (TMA), which mainly affects the renal vessels, with wall thickening, thrombosis and obstruction of the vascular lumen. Atypical HUS (aHUS) is a subtype of HUS in the TMA phenomena that results from the loss of regulation of the alternative complement pathway on cell surfaces and is generally considered to be from a genetic cause. Approximately 10% of HUS cases are classified as atypical HUS, which are associated with a more adverse prognosis, with a mortality rate up to 25% and progression to end stage renal disease in more than 50% of cases.

Condition or disease
Hemolytic-Uremic Syndrome

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Usefulness of a Diagnostic Algorithm to Diagnose Thrombotic Microangiopathies in Pregnancy
Actual Study Start Date : April 15, 2018
Estimated Primary Completion Date : September 15, 2018
Estimated Study Completion Date : December 15, 2018





Primary Outcome Measures :
  1. Incidence of TMAs [ Time Frame: The incidence will be evaluated for a period of 6 years, between January 2006 and December 2011. ]
    Incidence of TMAs (PTT and aHUS) in a cohort of obstetric critical care patients


Secondary Outcome Measures :
  1. Need for additional interventions [ Time Frame: The Need for additional interventions will be evaluated for a period of 6 years, between January 2006 and December 2011. ]
    Actions necessary to give proper management to patients. This is a categorical variable defined as: Hysterectomy, Vasoactive support, Mechanical ventilation, Renal Replacement

  2. Death [ Time Frame: The Death will be evaluated for a period of 6 years, between January 2006 and December 2011. ]
    Death (yes or no) of the woman during pregnancy or postpartum up to 42 days. This is a dichotomy measure

  3. Length of stay in the ICU [ Time Frame: The Length of stay in the ICU will be evaluated for a period of 6 years, between January 2006 and December 2011. ]
    Time in days of stay in an intensive care unit from admission to discharge or death of the patient. This is a continuos meeasure



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Ages Eligible for Study:   14 Years to 49 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All obstetric admissions registered between 2006 and 2011 in a medical-surgical ICU in a tertiary center (Gestion Salud clinic), in Cartagena, Colombia, with about 8000 deliveries per year, will be included in this study.
Criteria

Inclusion Criteria:

  • Patients will be included if admitted to the ICU with a diagnosis of hypertensive disorder associated with pregnancy and/or sepsis, and meet the following criteria for pregnancy related thrombotic microangiopathy.

Exclusion Criteria:

  • Non-pregnant women.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03580941


Locations
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Colombia
Gestion Salud
Cartagena, Bolivar, Colombia, 130015
Sponsors and Collaborators
Fundación Grupo de Investigación en Cuidados Intensivos y Obstetricia
Alexion Pharmaceuticals
Investigators
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Principal Investigator: Jose Rojas, MD. Msc Gestion Salud

Publications:
Juan P. Córdoba. Síndrome hemolítico urémico atípico, revisión de la literatura y documento de consenso. Enfoque diagnóstico y tratamiento. Revista Colombiana de Nefrologia 2(1): 19 -39, 2015

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Responsible Party: Fundación Grupo de Investigación en Cuidados Intensivos y Obstetricia
ClinicalTrials.gov Identifier: NCT03580941     History of Changes
Other Study ID Numbers: LS30885-2
First Posted: July 10, 2018    Key Record Dates
Last Update Posted: July 10, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Fundación Grupo de Investigación en Cuidados Intensivos y Obstetricia:
Pregnancy
Hemolytic-Uremic Syndrome

Additional relevant MeSH terms:
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Hemolysis
Hemolytic-Uremic Syndrome
Thrombotic Microangiopathies
Pathologic Processes
Uremia
Kidney Diseases
Urologic Diseases
Anemia, Hemolytic
Anemia
Hematologic Diseases
Thrombocytopenia
Blood Platelet Disorders