Cardiac SurgeryNCT01300117
Influence of Extracorporeal Circulation During Cardiac Surgery on the Development of Postoperative Thrombotic Thrombocytopenic Purpura (TTP)
An observational study of Cardiac Surgery, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether extracorporeal circulation during cardiac surgery has an influence on ADAMTS13-Activity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Surgery
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2010to not given
- 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: Patients undergoing cardiac surgery at the University Hospital
Who may be able to join
- cardiac surgery with or without (OPCAB) the use of extracorporeal circulation
- patient agrees
Who cannot join
- no agreement
- known TTP in medical history
Trial locations and contacts
1 site in 1 country.
Imke R Reinecke contact
Germany1 site, 1 recruiting
- Recruiting
Johann Wolfgang Goethe University Hospital
Frankfurt am Main, Hesse, 60590
Wolfgang Miesbach, Dr.med.
Imke R Reinecke
About this study
Official title: Influence of Extracorporeal Circulation During Cardiac Surgery on the Development of Postoperative TTP
The purpose of this study is to determine whether extracorporeal circulation during cardiac surgery has an influence on ADAMTS13-Activity.
- Conditions
- Cardiac Surgery
- Keywords
- cardiac surgery, adamts13, TTP, extracorporeal circulation, Heart-Lung Machine
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 |
|---|---|---|
| with extracorporeal circulation | Patients undergoing cardiac surgery with the use of an extracorporeal circulation | |
| without extracorporeal circulation | Patients undergoing cardiac surgery without the use of extracorporeal circulation (OPCAB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ADAMTS13-Activity over time
Measured: during surgery (at 1and 2 hours after beginning) and within the first 6 days after surgery
Secondary outcomes (5)
Change in ADAMTS13-Antibody over time
Measured: during surgery (at 1and 2 hours after beginning) and within the first 6 days after surgery
Change in Platelet count over time
Measured: during surgery (at 1and 2 hours after beginning) and within the first 6 days after surgery
time duration of extracorporeal circulation during surgery
Measured: during surgery
Amount of intraoperative given fluid replacement
Measured: during surgery
Amount of given blood products (red blood cells)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2011 (estimated)
- Study startOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac SurgeryStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01300117
- Sponsor's protocol ID
- TTP-KC
- Status last verified
- Dec 2011
- First submitted
- 18 Feb 2011
- Last updated
- 29 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Extracorporeal Circulation During Cardiac Surgery on the Development of Postoperative TTP
- ClinicalTrials.gov ID
- NCT01300117
- Acronym / sponsor ID
- TTP-KC
- Conditions
- Cardiac Surgery
- Keywords
- cardiac surgery, adamts13, TTP, extracorporeal circulation, Heart-Lung Machine
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Oct 2010
- First posted
- 21 Feb 2011 (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.
The purpose of this study is to determine whether extracorporeal circulation during cardiac surgery has an influence on ADAMTS13-Activity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with extracorporeal circulation | – | –Patients undergoing cardiac surgery with the use of an extracorporeal circulation |
| without extracorporeal circulation | – | –Patients undergoing cardiac surgery without the use of extracorporeal circulation (OPCAB) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cardiac surgery at the University Hospital
Key inclusion criteria (2 listed)
- cardiac surgery with or without (OPCAB) the use of extracorporeal circulation
- patient agrees
Key exclusion criteria (2 listed)
- no agreement
- known TTP in medical history
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
Change in ADAMTS13-Activity over time
Time frame: during surgery (at 1and 2 hours after beginning) and within the first 6 days after surgery
5 secondary outcomes
Change in ADAMTS13-Antibody over time
Time frame: during surgery (at 1and 2 hours after beginning) and within the first 6 days after surgery
Change in Platelet count over time
Time frame: during surgery (at 1and 2 hours after beginning) and within the first 6 days after surgery
time duration of extracorporeal circulation during surgery
Time frame: during surgery
Amount of intraoperative given fluid replacement
Time frame: during surgery
Amount of given blood products (red blood cells)
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2011.
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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.
Imke R Reinecke contact
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 Cardiac Surgery, run by Johann Wolfgang Goethe University Hospital 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 2 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: status not confirmed, as of the sponsor's last update on 29 Dec 2011. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wolfgang Miesbach (+49696301 ext. 5051, wolfgang.miesbach@kgu.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ADAMTS13-Activity over time (time frame: during surgery (at 1and 2 hours after beginning) and within the first 6 days after surgery). 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 29 Dec 2011.