PreeclampsiaNCT01967355
Prolongation of Pregnancy in Preeclampsia by Therapeutic Lipid Apheresis
A study testing lipid apheresis in people with Preeclampsia and Dyslipidemia, run by Karl Winkler at 1 site in Germany.
Trial summary
Preeclampsia is a disease which occurs in about 6-8% of all pregnancies and is the main cause of maternal and fetal morbidity and mortality. The cause of preeclampsia is still not clear and the only therapy is preterm caesarean section. In severe preeclampsia an accumulation of triglyceride-rich lipoproteins occurs. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preeclampsia, Dyslipidemia, Proteinuria
- What is being tested?
- lipid apheresis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2013to 8 May 2014
- Phase
- Interventional
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- pregnant women
- early preeclampsia (< 32 week of pregnancy)
- arterial hypertension during pregnancy
- proteinuria (=> 1 + dipstick or 0> 300 mg/24h)
- and/or intrauterine growth retardation (IUGR)
- informed consent
Who cannot join
- every acute indication for immediate delivery
- no informed consent
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute of Clinical Chemistry and Laboratory Medicine, University Hospital Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79104
About this study
Preeclampsia is a disease which occurs in about 6-8% of all pregnancies and is the main cause of maternal and fetal morbidity and mortality. The cause of preeclampsia is still not clear and the only therapy is preterm caesarean section. In severe preeclampsia an accumulation of triglyceride-rich lipoproteins occurs. Therefore, lipid apheresis is performed as lipid-removing therapy for treatment of preeclampsia in order to prolong pregnancy and provide the fetus more time for maturation. In this individual treatment patients with early preeclampsia (<= 32 weeks of gestation) will be offered a H.E.L.P.-apheresis to postpone caesarean section and therefore prolong pregnancy.
- Conditions
- Preeclampsia, Dyslipidemia, Proteinuria, Hypertension
- Being tested
- lipid apheresis
- Keywords
- preeclampsia, lipid apheresis, apheresis
- Medical subject headings
- Pre-Eclampsia, Dyslipidemias, Proteinuria, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lipid apheresisOther
Also called H.E.L.P.-Apheresis
| Study group | Role | What they receive |
|---|---|---|
| Lipid apheresis | Experimental | Lipid apheresis: lipid removing therapy,frequency and duration depending on the symptoms of mother and fetus. Receives: Other: lipid apheresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolongation of pregnancy
A deteriorating clinical condition of the mother and the fetus necessitates a caesarean section (c.s.). However, if c.s. takes place too early lung maturation of the fetus may not be completed. Apheresis is initiated and will be continued until lung maturity is achieved and the clinical condition of the mother and the fetus improves.
Measured: Mother will be followed up for the duration of hospital stay, that is from first lipid apheresis until the discharge of the mother in the days following birth (an expected average of 3-4 weeks).
Secondary outcomes (1)
Reduction of lipoprotein levels
Measured: Mother will be followed up for the duration of hospital stay, that is from first lipid apheresis until the discharge of the mother in the days following birth (an expected average of 3-4 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2013 (estimated)
- Study startApr 2013
- Primary completion8 May 2014
- Study completion8 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karl Winkler
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Karl Winkler, University Hospital Freiburg
- Investigators
- Karl Winkler, Prof.Dr.med., Principal investigator, Institute of Clinical Chemestry and Laboratory Medicine, University Hospital Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01967355
- Sponsor's protocol ID
- 2013-15
- Status last verified
- Aug 2018
- First submitted
- 26 Jul 2013
- Last updated
- 9 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Winkler K, Lorey C, Contini C, Augustinski V, Putz G, Rothele E, Benner A, Fuchs H, Pecks U, Markfeld-Erol F, Kunze M. Comparison of double-filtration plasmapheresis (DFPP) versus heparin-mediated extracorporeal LDL-precipitation (HELP)-apheresis in early-onset preeclampsia. Pregnancy Hypertens. 2024 Jun;36:101128. doi: 10.1016/j.preghy.2024.101128. Epub 2024 May 9.
PubMed 38728925Contini C, Jansen M, Konig B, Markfeld-Erol F, Kunze M, Zschiedrich S, Massing U, Merfort I, Prompeler H, Pecks U, Winkler K, Putz G. Lipoprotein turnover and possible remnant accumulation in preeclampsia: insights from the Freiburg Preeclampsia H.E.L.P.-apheresis study. Lipids Health Dis. 2018 Mar 14;17(1):49. doi: 10.1186/s12944-018-0698-4.
PubMed 29540222
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolongation of Pregnancy in Preeclampsia by Therapeutic Lipid Apheresis
- ClinicalTrials.gov ID
- NCT01967355
- Acronym / sponsor ID
- 2013-15
- Conditions
- Preeclampsia, Dyslipidemia, Proteinuria, Hypertension
- Keywords
- preeclampsia, lipid apheresis, apheresis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Karl WinklerUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- 8 May 2014 (actual)
- Study completion
- 8 May 2014 (actual)
- First posted
- 22 Oct 2013 (estimated)
- 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.
Preeclampsia is a disease which occurs in about 6-8% of all pregnancies and is the main cause of maternal and fetal morbidity and mortality. The cause of preeclampsia is still not clear and the only therapy is preterm caesarean section. In severe preeclampsia an accumulation of triglyceride-rich lipoproteins occurs. Therefore, lipid apheresis is performed as lipid-removing therapy for treatment of preeclampsia in order to prolong pregnancy and provide the fetus more time for maturation. In this individual treatment patients with early preeclampsia (<= 32 weeks of gestation) will be offered a H.E.L.P.-apheresis to postpone caesarean section and therefore prolong pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lipid apheresis | Experimental | Other: lipid apheresisLipid apheresis: lipid removing therapy,frequency and duration depending on the symptoms of mother and fetus. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- pregnant women
- early preeclampsia (< 32 week of pregnancy)
- arterial hypertension during pregnancy
- proteinuria (=> 1 + dipstick or 0> 300 mg/24h)
- and/or intrauterine growth retardation (IUGR)
Key exclusion criteria (2 listed)
- every acute indication for immediate delivery
- no 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 |
|---|---|---|
| lipid apheresisAlso: H.E.L.P.-Apheresis | Other | Lipid apheresis |
Primary outcome
Prolongation of pregnancy
Time frame: Mother will be followed up for the duration of hospital stay, that is from first lipid apheresis until the discharge of the mother in the days following birth (an expected average of 3-4 weeks).
A deteriorating clinical condition of the mother and the fetus necessitates a caesarean section (c.s.). However, if c.s. takes place too early lung maturation of the fetus may not be completed. Apheresis is initiated and will be continued until lung maturity is achieved and the clinical condition of the mother and the fetus improves.
1 secondary outcome
Reduction of lipoprotein levels
Time frame: Mother will be followed up for the duration of hospital stay, that is from first lipid apheresis until the discharge of the mother in the days following birth (an expected average of 3-4 weeks).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2018.
- Derived from this study: PubMed 38728925Winkler K, Lorey C, Contini C, Augustinski V, Putz G, Rothele E, Benner A, Fuchs H, Pecks U, Markfeld-Erol F, Kunze M. Comparison of double-filtration plasmapheresis (DFPP) versus heparin-mediated extracorporeal LDL-precipitation (HELP)-apheresis in early-onset preeclampsia. Pregnancy Hypertens. 2024 Jun;36:101128. doi: 10.1016/j.preghy.2024.101128. Epub 2024 May 9.
- Derived from this study: PubMed 29540222Contini C, Jansen M, Konig B, Markfeld-Erol F, Kunze M, Zschiedrich S, Massing U, Merfort I, Prompeler H, Pecks U, Winkler K, Putz G. Lipoprotein turnover and possible remnant accumulation in preeclampsia: insights from the Freiburg Preeclampsia H.E.L.P.-apheresis study. Lipids Health Dis. 2018 Mar 14;17(1):49. doi: 10.1186/s12944-018-0698-4.
- Individual participant dataSharing planned: No
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Severe Preeclampsia
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.
Karl Winkler, Prof.Dr.med. principal investigator
Institute of Clinical Chemestry and Laboratory Medicine, University Hospital Freiburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lipid apheresis in people with Preeclampsia and Dyslipidemia, run by Karl Winkler at 1 site in Germany.
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 6 inclusion and 2 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: finished, as of the sponsor's last update on 9 Aug 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prolongation of pregnancy (time frame: Mother will be followed up for the duration of hospital stay, that is from first lipid apheresis until the discharge of the mother in the days following birth (an expected average of 3-4 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01967355, which also lists 2 linked publications.
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 9 Aug 2018.