Usefulness of a Diagnostic Algorithm to Diagnose Thrombotic Microangiopathies in Pregnancy

NCT03580941 | Unknown

• 1 other identifier: LS30885-2
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemolytic-Uremic Syndrome

Keywords

Pregnancy; Hemolytic-Uremic Syndrome

Outcome Measures

Primary Outcomes (1)

• Incidence of TMAs

  Incidence of TMAs (PTT and aHUS) in a cohort of obstetric critical care patients

  The incidence will be evaluated for a period of 6 years, between January 2006 and December 2011.

Secondary Outcomes (3)

• Need for additional interventions

  The Need for additional interventions will be evaluated for a period of 6 years, between January 2006 and December 2011.

• Death

  The Death will be evaluated for a period of 6 years, between January 2006 and December 2011.

• Length of stay in the ICU

  The Length of stay in the ICU will be evaluated for a period of 6 years, between January 2006 and December 2011.

Eligibility Criteria

• Age: 14 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Non-pregnant women.

Sponsors & Collaborators

• Fundación Grupo de Investigación en Cuidados Intensivos y Obstetricia: lead
• Alexion Pharmaceuticals, Inc.: collaborator

Study Sites (1)

Gestion Salud

Cartagena, Departamento de Bolívar, 130015, Colombia

Location

Related Publications (6)

• Alkema L, Chou D, Hogan D, Zhang S, Moller AB, Gemmill A, Fat DM, Boerma T, Temmerman M, Mathers C, Say L; United Nations Maternal Mortality Estimation Inter-Agency Group collaborators and technical advisory group. Global, regional, and national levels and trends in maternal mortality between 1990 and 2015, with scenario-based projections to 2030: a systematic analysis by the UN Maternal Mortality Estimation Inter-Agency Group. Lancet. 2016 Jan 30;387(10017):462-74. doi: 10.1016/S0140-6736(15)00838-7. Epub 2015 Nov 13.

  PMID: 26584737 BACKGROUND

• Campistol JM, Arias M, Ariceta G, Blasco M, Espinosa M, Grinyo JM, Praga M, Torra R, Vilalta R, Rodriguez de Cordoba S. An update for atypical haemolytic uraemic syndrome: diagnosis and treatment. A consensus document. Nefrologia. 2013 Jan 18;33(1):27-45. doi: 10.3265/Nefrologia.pre2012.Nov.11781. English, Spanish.

  PMID: 23364625 BACKGROUND

• 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

  BACKGROUND

• Campistol JM, Arias M, Ariceta G, Blasco M, Espinosa L, Espinosa M, Grinyo JM, Macia M, Mendizabal S, Praga M, Roman E, Torra R, Valdes F, Vilalta R, Rodriguez de Cordoba S. An update for atypical haemolytic uraemic syndrome: diagnosis and treatment. A consensus document. Nefrologia. 2015;35(5):421-47. doi: 10.1016/j.nefro.2015.07.005. Epub 2015 Oct 9. English, Spanish.

  PMID: 26456110 BACKGROUND

• Sibai BM. Imitators of severe pre-eclampsia. Semin Perinatol. 2009 Jun;33(3):196-205. doi: 10.1053/j.semperi.2009.02.004.

  PMID: 19464511 BACKGROUND

• Landis JR, Koch GG. The measurement of observer agreement for categorical data. Biometrics. 1977 Mar;33(1):159-74.

  PMID: 843571 BACKGROUND

MeSH Terms

Conditions

Hemolytic-Uremic Syndrome

Condition Hierarchy (Ancestors)

Uremia; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia

Study Officials

• Jose Rojas, MD. Msc

  Gestion Salud

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2018
• First Posted: July 10, 2018
• Study Start: April 15, 2018
• Primary Completion: August 30, 2020
• Study Completion: November 30, 2020
• Last Updated: June 2, 2020

Record last verified: 2020-05

Locations

CO (1)