CoagulopathyNCT00998647
Modified Ultrafiltration in Cardiac Surgery
An observational study of Coagulopathy and Rethoracotomy, run by Goethe University at 1 site in Germany.
Trial summary
The purpose of this study is to find out, whether filtration of the blood in patients undergoing cardiac surgery, beneficially influences the coagulation system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coagulopathy, Rethoracotomy, Blood Loss
- What is being tested?
- modified ultrafiltration using Maquet haemoconcentrator, BC 20 plus
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2009to Apr 2010
- 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: electice cardiac surgery patients undergoing complex procedures: CABG and valve double-valve aortic surgery Re-Dos
Who may be able to join
- patients undergoing complex cardiac surgery procedures
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Germany1 site
Goethe University hospital, Clinic for Anaesthesioloy
Frankfurt am Main, 60590
About this study
Official title: Assessment of the Influence of Modified Ultrafiltration on Primary and Secondary Hemostasis in Cardiac Surgery Patients
The purpose of this study is to find out, whether filtration of the blood in patients undergoing cardiac surgery, beneficially influences the coagulation system.
Read the detailed description
The impact of modified ultrafiltration following extracorporeal circulation on primary and secondary hemostasis is controversial. In this study we intend to assess both, primary and secondary hemostasis prior to and after the usage of modified ultrafiltration. Primary hemostasis is assessed using Multiple Electrode Aggregometry (Multiplate) and secondary hemostasis is assessed performing thrombelastometry using the ROTEM device. Patients are preoperatively randomized to receive either modified ultrafiltration or no filtration.
- Conditions
- Coagulopathy, Rethoracotomy, Blood Loss, Transfusion Requirements
- Being tested
- modified ultrafiltration using Maquet haemoconcentrator, BC 20 plus
- Keywords
- modified ultrafiltration, cardiac surgery, ROTEM, Multiple Electrode Aggregometry
- Medical subject headings
- Hemostatic Disorders, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified ultrafiltration using Maquet haemoconcentrator, BC 20 plusDevice
Also called Maquet haemoconcentrator, BC 20 plus
usage of modified ultrafiltration following extracorporeal circulation; filtration about 1,5 liters and re-fill with colloids
| Study group | Role | What they receive |
|---|---|---|
| with modified ultrafiltration | elective cardiac surgery patients undergoing complex surgical intervention:
coronary artery bypass grafting AND valve surgery double valve surgery aortic surgery Re-Dos Receives: Device: modified ultrafiltration using Maquet haemoconcentrator, BC 20 plus | |
| without modified ultrafiltration | elective cardiac surgery patients undergoing complex surgical intervention:
coronary artery bypass grafting AND valve surgery double valve surgery aortic surgery Re-Dos Receives: Device: modified ultrafiltration using Maquet haemoconcentrator, BC 20 plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
ex vivo platelet aggregation (TRAPtest)
Measured: 20 min after filtration
Secondary outcomes (5)
secondary hemostasis assessed by ROTEM
Measured: 20 min before and after filtration
blood loss
Measured: 24 h after filtration
kind and number of transfused blood products
Measured: 24h after filtration
conventional coagulation analyses (INR, aPTT, platelet count, fibrinogen concentration)
Measured: 20 min before and after filtration
rate of rethoracotomy for bleeding
Measured: 24h after filtration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2009 (estimated)
- Study startJun 2009
- Primary completionApr 2010
- Study completionApr 2010
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 CoagulopathyStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Investigators
- Christian F Weber, Dr., Principal investigator, Goethe University Frankfurt, Clinic for Anaesthesiology, Theodor Stern Kai 7, 60590 Frankfurt am Main, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00998647
- Sponsor's protocol ID
- 370/08 MUF
- Status last verified
- Oct 2009
- First submitted
- 19 Oct 2009
- Last updated
- 23 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Boodhwani M, Williams K, Babaev A, Gill G, Saleem N, Rubens FD. Ultrafiltration reduces blood transfusions following cardiac surgery: A meta-analysis. Eur J Cardiothorac Surg. 2006 Dec;30(6):892-7. doi: 10.1016/j.ejcts.2006.09.014. Epub 2006 Oct 13.
PubMed 17046273Weber CF, Jambor C, Strasser C, Moritz A, Papadopoulos N, Zacharowski K, Meininger D. Normovolemic modified ultrafiltration is associated with better preserved platelet function and less postoperative blood loss in patients undergoing complex cardiac surgery: a randomized and controlled study. J Thorac Cardiovasc Surg. 2011 May;141(5):1298-304. doi: 10.1016/j.jtcvs.2010.09.057. Epub 2010 Dec 3.
PubMed 21130474
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Influence of Modified Ultrafiltration on Primary and Secondary Hemostasis in Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT00998647
- Acronym / sponsor ID
- 370/08 MUF
- Conditions
- Coagulopathy, Rethoracotomy, Blood Loss, Transfusion Requirements
- Keywords
- modified ultrafiltration, cardiac surgery, ROTEM, Multiple Electrode Aggregometry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 20 Oct 2009 (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 find out, whether filtration of the blood in patients undergoing cardiac surgery, beneficially influences the coagulation system.
Detailed description
The impact of modified ultrafiltration following extracorporeal circulation on primary and secondary hemostasis is controversial. In this study we intend to assess both, primary and secondary hemostasis prior to and after the usage of modified ultrafiltration. Primary hemostasis is assessed using Multiple Electrode Aggregometry (Multiplate) and secondary hemostasis is assessed performing thrombelastometry using the ROTEM device. Patients are preoperatively randomized to receive either modified ultrafiltration or no filtration.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with modified ultrafiltration | – | Device: modified ultrafiltration using Maquet haemoconcentrator, BC 20 pluselective cardiac surgery patients undergoing complex surgical intervention: coronary artery bypass grafting AND valve surgery double valve surgery aortic surgery Re-Dos |
| without modified ultrafiltration | – | Device: modified ultrafiltration using Maquet haemoconcentrator, BC 20 pluselective cardiac surgery patients undergoing complex surgical intervention: coronary artery bypass grafting AND valve surgery double valve surgery aortic surgery Re-Dos |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- electice cardiac surgery patients undergoing complex procedures: CABG and valve double-valve aortic surgery Re-Dos
Key inclusion criteria (1 listed)
- patients undergoing complex cardiac surgery procedures
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| modified ultrafiltration using Maquet haemoconcentrator, BC 20 plusAlso: Maquet haemoconcentrator, BC 20 plususage of modified ultrafiltration following extracorporeal circulation; filtration about 1,5 liters and re-fill with colloids | Device | with modified ultrafiltration, without modified ultrafiltration |
Primary outcome
ex vivo platelet aggregation (TRAPtest)
Time frame: 20 min after filtration
5 secondary outcomes
secondary hemostasis assessed by ROTEM
Time frame: 20 min before and after filtration
blood loss
Time frame: 24 h after filtration
kind and number of transfused blood products
Time frame: 24h after filtration
conventional coagulation analyses (INR, aPTT, platelet count, fibrinogen concentration)
Time frame: 20 min before and after filtration
rate of rethoracotomy for bleeding
Time frame: 24h after filtration
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 23 Apr 2010.
- Background: PubMed 17046273Boodhwani M, Williams K, Babaev A, Gill G, Saleem N, Rubens FD. Ultrafiltration reduces blood transfusions following cardiac surgery: A meta-analysis. Eur J Cardiothorac Surg. 2006 Dec;30(6):892-7. doi: 10.1016/j.ejcts.2006.09.014. Epub 2006 Oct 13.
- Derived from this study: PubMed 21130474Weber CF, Jambor C, Strasser C, Moritz A, Papadopoulos N, Zacharowski K, Meininger D. Normovolemic modified ultrafiltration is associated with better preserved platelet function and less postoperative blood loss in patients undergoing complex cardiac surgery: a randomized and controlled study. J Thorac Cardiovasc Surg. 2011 May;141(5):1298-304. doi: 10.1016/j.jtcvs.2010.09.057. Epub 2010 Dec 3.
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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.
Christian F Weber, Dr. principal investigator
Goethe University Frankfurt, Clinic for Anaesthesiology, Theodor Stern Kai 7, 60590 Frankfurt am Main, Germany
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 Coagulopathy and Rethoracotomy, run by Goethe University 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 1 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 23 Apr 2010. 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?
ex vivo platelet aggregation (TRAPtest) (time frame: 20 min after filtration). 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 NCT00998647, 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 23 Apr 2010.