Thrombotic Thrombocytopenic PurpuraNCT03605511
TTP and aHUS in Complicated Pregnancies
An observational study of Thrombotic Thrombocytopenic Purpura and Atypical Hemolytic Uremic Syndrome, run by University College, London at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Thrombotic Thrombocytopenic Purpura, Atypical Hemolytic Uremic Syndrome, Pre-Eclampsia
- What is being tested?
- ADAMTS 13, complement and angiogenic biomarkers
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Sep 2018to 14 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Child, Adult, Older adult
Study population: All women receiving obstetric care at University College Hospitals London NHS Trust over the study period
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University College London Hospital
London, NW1 2PG
Lucy Neave, MBBS, lucy.neave.17@ucl.ac.uk
About this study
Official title: A Observational Study to Determine the Prevalence of Pregnancy-related Thrombotic Thrombocytopenic Purpura and Atypical Haemolytic Uraemic Syndrome in Women Affected by Specific Obstetric Complications
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
- Conditions
- Thrombotic Thrombocytopenic Purpura, Atypical Hemolytic Uremic Syndrome, Pre-Eclampsia, HELLP Syndrome, Thrombocytopenia, IUGR
- Being tested
- ADAMTS 13, complement and angiogenic biomarkers
- Medical subject headings
- Purpura, Thrombotic Thrombocytopenic, Atypical Hemolytic Uremic Syndrome, Pre-Eclampsia, HELLP Syndrome, Thrombocytopenia, Stillbirth, Thrombotic Microangiopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADAMTS 13, complement and angiogenic biomarkersDiagnostic test
ADAMTS 13, complement and angiogenic biomarkers
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of TTP and aHUS in the cohort
Number of new cases identified as a percentage of sample size
Measured: At study completion, approximately 18 months after recruitment of first patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2018
- Study start21 Sep 2018
- Primary completion14 Mar 2020 (estimated)
- Study completion14 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombotic Thrombocytopenic PurpuraStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03605511
- Sponsor's protocol ID
- 18/0217
- Status last verified
- Jul 2018
- First submitted
- 2 Jul 2018
- Last updated
- 25 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Observational Study to Determine the Prevalence of Pregnancy-related Thrombotic Thrombocytopenic Purpura and Atypical Haemolytic Uraemic Syndrome in Women Affected by Specific Obstetric Complications
- ClinicalTrials.gov ID
- NCT03605511
- Acronym / sponsor ID
- 18/0217
- Conditions
- Thrombotic Thrombocytopenic Purpura, Atypical Hemolytic Uremic Syndrome, Pre-Eclampsia, HELLP Syndrome, Thrombocytopenia, IUGR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 21 Sep 2018 (actual)
- Primary completion
- 14 Mar 2020 (estimated)
- Study completion
- 14 Mar 2020 (estimated)
- First posted
- 30 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Age groups
- Child, Adult, Older adult
- Study population
- All women receiving obstetric care at University College Hospitals London NHS Trust over the study period
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADAMTS 13, complement and angiogenic biomarkersADAMTS 13, complement and angiogenic biomarkers | Diagnostic test | – |
Primary outcome
Frequency of TTP and aHUS in the cohort
Time frame: At study completion, approximately 18 months after recruitment of first patient
Number of new cases identified as a percentage of sample size
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2018.
Related trials for Thrombotic Thrombocytopenic Purpura
RecruitingObservational study
A Study to Learn More About the Treatment of People With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Who Received Recombinant ADAMTS13 (rADAMTS13) as Part of the Early Access Program
Thrombotic Thrombocytopenic Purpura (TTP)
RecruitingObservational study
A Survey of Recombinant ADAMTS13 in Participants With Congenital Thrombotic Thrombocytopenic Purpura
Thrombotic Thrombocytopenic Purpura (TTP)
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
Not yet recruitingPhase 1/2
TGD001 Treatment in Thrombotic Microangiopathies
Thrombotic Microangiopathies, ITP Immune-Mediated Thrombocytopenia
RecruitingPhase 2
A Pilot Study of Efgartigimod for Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP)
Immune-mediated Thrombotic Thrombocytopenic Purpura
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombotic Thrombocytopenic Purpura and Atypical Hemolytic Uremic Syndrome, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucy Neave, MBBS (+44 203 447 9884, lucy.neave.17@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of TTP and aHUS in the cohort (time frame: At study completion, approximately 18 months after recruitment of first patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2018; AzTrials last refreshed its copy on 27 Oct 2026.