Clotting Disorder Due to Plasma Exchange TherapyNCT02095821
Fibrinogen as a Surrogate for Global Haemostasis in Plasma Exchange
An observational study of Clotting Disorder Due to Plasma Exchange Therapy and Humoral Rejection After Kidney Transplantation, run by Hannover Medical School at 1 site in Germany.
Trial summary
Plasma exchange is a frequently used therapy in many antibody-mediated disorders, such as humoral rejection after kidney transplantation. Treatment frequency is adjusted to daily measured fibrinogen blood levels to prevent bleeding complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Clotting Disorder Due to Plasma Exchange Therapy, Humoral Rejection After Kidney Transplantation
- How many people
- 2 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2014to Oct 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Tertiary hospital patients after kidney transplantation, humoral rejection
Who may be able to join
- plasma exchange therapy due to humoral rejection after kidney transplantation
Who cannot join
- hereditary coagulopathy
- chronic liver disease (Child C)
- therapeutic anticoagulation
- malnutrition (BMI<17.5)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Study of Fibrinogen as a Surrogate for Global Haemostasis in Plasma Exchange Therapy
Plasma exchange is a frequently used therapy in many antibody-mediated disorders, such as humoral rejection after kidney transplantation. Treatment frequency is adjusted to daily measured fibrinogen blood levels to prevent bleeding complications. However, data about the correlation of fibrinogen blood levels and function of the coagulation system during plasma exchange therapy is scarce. In the present study we examine blood fibrinogen levels and coagulation factors as well as thrombin clotting time in patients under plasma exchange therapy.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Humoral rejection, TPE | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombin clotting time
Daily measurement after initiation of plasma exchange therapy until treatment course is finished
Measured: Baseline, daily measurement until hospital discharge (avarage hospital stay: 10 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startFeb 2014
- Primary completionOct 2019
- Study completionOct 2019
Why it stopped: Study was stopped due to recruitment failure
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clotting Disorder Due to Plasma Exchange TherapyStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Julius Schmidt, Hannover Medical School
- Investigators
- Sascha David, MD, Principal investigator, Medical School Hannover
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095821
- Sponsor's protocol ID
- FIB-2110-2014
- Status last verified
- Apr 2020
- First submitted
- 27 Feb 2014
- Last updated
- 20 Apr 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Fibrinogen as a Surrogate for Global Haemostasis in Plasma Exchange Therapy
- ClinicalTrials.gov ID
- NCT02095821
- Acronym / sponsor ID
- FIB-2110-2014
- Conditions
- Clotting Disorder Due to Plasma Exchange Therapy, Humoral Rejection After Kidney Transplantation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study was stopped due to recruitment failure
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 26 Mar 2014 (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.
Plasma exchange is a frequently used therapy in many antibody-mediated disorders, such as humoral rejection after kidney transplantation. Treatment frequency is adjusted to daily measured fibrinogen blood levels to prevent bleeding complications. However, data about the correlation of fibrinogen blood levels and function of the coagulation system during plasma exchange therapy is scarce. In the present study we examine blood fibrinogen levels and coagulation factors as well as thrombin clotting time in patients under plasma exchange therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Humoral rejection, TPE | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Tertiary hospital patients after kidney transplantation, humoral rejection
Key inclusion criteria (1 listed)
- plasma exchange therapy due to humoral rejection after kidney transplantation
Key exclusion criteria (4 listed)
- hereditary coagulopathy
- chronic liver disease (Child C)
- therapeutic anticoagulation
- malnutrition (BMI<17.5)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Thrombin clotting time
Time frame: Baseline, daily measurement until hospital discharge (avarage hospital stay: 10 days)
Daily measurement after initiation of plasma exchange therapy until treatment course is finished
Results and safety
The study was stopped early (reason given: Study was stopped due to recruitment failure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
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.
Sascha David, MD principal investigator
Medical School Hannover
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 Clotting Disorder Due to Plasma Exchange Therapy and Humoral Rejection After Kidney Transplantation, run by Hannover Medical School 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 1 inclusion and 4 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: stopped early, as of the sponsor's last update on 20 Apr 2020. 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 was stopped early (reason given: Study was stopped due to recruitment failure). Results are not available in the source record.
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?
Thrombin clotting time (time frame: Baseline, daily measurement until hospital discharge (avarage hospital stay: 10 days)). 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 20 Apr 2020.