TTP and aHUS in Complicated Pregnancies

• Conditions: Thrombocytopenia; Pre-Eclampsia; Thrombotic Microangiopathies; Thrombotic Thrombocytopenic Purpura; Atypical Hemolytic Uremic Syndrome; HELLP Syndrome; IUGR; Stillbirth

• Registration Number: NCT03605511
• Lead Sponsor: University College, London

Brief Summary

A single site observational study aiming to:

(i) Identify cases of previously undiagnosed thrombotic thrombocytopenic purpura (TTP) and atypical haemolytic syndrome (aHUS) in a cohort of women with complicated pregnancies (ii) Characterise the clinical features of these cases and (ii) Identify clinical features or biomarkers which may help distinguish TTP/aHUS from other complications of pregnancy such as preeclampsia

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-07
• Study First Submitted: 2018-07-02
• Study First Submitted QC: 2018-07-20
• Study First Posted: 2018-07-30
• Study Start: 2018-09-21
• Last Update Submitted: 2018-09-21
• Last Update Posted: 2018-09-25
• Primary Completion: 2020-03-14
• Study Completion: 2020-03-14

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• Women, either currently pregnant or recently postpartum, and affected by one or more of the following complications in the index pregnancy: (i) Preeclampsia with evidence of end organ damage (renal/ liver/ haematological/ neurological) or uteroplacental dysfunction (FGR/IUFD) (ii) HELLP syndrome (iii) Fetal growth restriction (FGR) (growth <10th centile) that is unexplained (ie not due to infection, fetal structural anomaly, fetal chromosomal or pre-existing maternal medical problem) (iv) Intrauterine fetal demise (IUFD) after 20 weeks' gestation that is unexplained (v) Unexplained new onset renal impairment (defined by serum creatinine >85umol/L 1st trimester, or >80umol/L 2nd trimester, or >90 umol/L 3rd trimester[32]; OR an increase in serum creatinine by (i) at least 1.5 times the baseline or (ii) of equal or greater than 26.5umol/L (as per KDIGO criteria) (vi) Unexplained new onset thrombocytopenia (platelets <75x10^9/L)

Exclusion Criteria

• Previous diagnosis of TTP or aHUS
• Known disorder of complement dysregulation
• Patients not wishing to participate
• Patients aged less than 16
• Patients lacking capacity to provide informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Frequency of TTP and aHUS in the cohort	At study completion, approximately 18 months after recruitment of first patient	Number of new cases identified as a percentage of sample size

Trial Locations

Locations (1)

University College London Hospital; 🇬🇧 London, United Kingdom