Blood CoagulationTEG-PKTNCT02385006
Thromboelastography and Pancreas-kidney Transplantation
A study testing Blood sample in people with Blood Coagulation, run by Hospices Civils de Lyon at 1 site in France.
Trial summary
Type of study:Prospective, single-center, non-therapeutic, of routine care No randomization, no modifications of the usual care, study results are not available for the physicians in charge of the patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Coagulation
- What is being tested?
- Blood sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2013to Nov 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men, women > 18 years old
- Kidney or pancreas-kidney recipients
- Not opposed to research
- With no legal protection
- Affiliated to social security system
Who cannot join
- -Enrollment in an other research protocol, incompatible with the trial according to the investigator
Trial locations and contacts
1 site in 1 country.
France1 site
Anesthesiology and Critical Care Medicine, Edouard Herriot Hospital, Hospices Civils de Lyon
Lyon, 69003
About this study
Official title: Thromboelastographic Profile During Simultaneous Pancreas-kidney Transplantation
Type of study:Prospective, single-center, non-therapeutic, of routine care No randomization, no modifications of the usual care, study results are not available for the physicians in charge of the patient.
Objectives:
Read more
- The main objective of this study is to evaluate the ability of the thromboelastogram (ROTEM®) to detect clotting disorders related to pancreas-kidney transplantation, comparing ROTEM ® profiles during the perioperative period of two different types of transplantation (kidney alone and simultaneous pancreas-kidney)
- The secondary objectives are:
- To assess the incidence and type of coagulation disorders during the perioperative period of these two types of transplantation
- To study correlation values between thrombolelastogram and standard coagulation parameters
Population study:
- Evaluated group: 40 pancreas-kidney recipients
- Control group: 80 kidney recipients
- Recruitment periods: 24 months
- Patient Monitoring: 48 hours
- Total duration of the study: 36 months.
- Ethics: Study of routine care. Oral and written information given to patients. Validation of the study protocol by the local ethics committee (CPP Sud Est II: Protocol No. HCL / P 2012.727)
- Conditions
- Blood Coagulation
- Being tested
- Blood sample
- Keywords
- Thromboelastography, simulatneous pancreas-kidney transplantation
- Medical subject headings
- Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sampleBiological
| Study group | Role | What they receive |
|---|---|---|
| Arm kidney transplanted | Other | Arm kidney transplanted: all patients who receive kidney transplantation Receives: Biological: Blood sample |
| Arm pancreas-kidney transplanted | Other | Arm pancreas-kidney transplanted: all patients who receive pancreas-kidney transplantation Receives: Biological: Blood sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring
Measured: preoperative period
Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring
Measured: 45 min after transplant unclamp
Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring
Measured: Intensice Care Unit admission
Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring
Measured: 24 hours
Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring
Measured: 48 hours
Secondary outcomes (5)
standard coagulation parameters
Measured: preoperative period
standard coagulation parameters
Measured: 45 min after transplant unclamp
standard coagulation parameters
Measured: Intensice Care Unit admission
standard coagulation parameters
Measured: 24 hours
standard coagulation parameters
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2015 (estimated)
- Study startFeb 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood CoagulationStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02385006
- Sponsor's protocol ID
- 2012.727
- Acronym
- TEG-PKT
- Status last verified
- Mar 2013
- First submitted
- 26 Feb 2015
- Last updated
- 11 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thromboelastographic Profile During Simultaneous Pancreas-kidney Transplantation
- ClinicalTrials.gov ID
- NCT02385006
- Acronym / sponsor ID
- TEG-PKT / 2012.727
- Conditions
- Blood Coagulation
- Keywords
- Thromboelastography, simulatneous pancreas-kidney transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 11 Mar 2015 (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.
Type of study:Prospective, single-center, non-therapeutic, of routine care No randomization, no modifications of the usual care, study results are not available for the physicians in charge of the patient.
Objectives:
- The main objective of this study is to evaluate the ability of the thromboelastogram (ROTEM®) to detect clotting disorders related to pancreas-kidney transplantation, comparing ROTEM ® profiles during the perioperative period of two different types of transplantation (kidney alone and simultaneous pancreas-kidney)
- The secondary objectives are:
- To assess the incidence and type of coagulation disorders during the perioperative period of these two types of transplantation
- To study correlation values between thrombolelastogram and standard coagulation parameters
Population study:
- Evaluated group: 40 pancreas-kidney recipients
- Control group: 80 kidney recipients
- Recruitment periods: 24 months
- Patient Monitoring: 48 hours
- Total duration of the study: 36 months.
- Ethics: Study of routine care. Oral and written information given to patients. Validation of the study protocol by the local ethics committee (CPP Sud Est II: Protocol No. HCL / P 2012.727)
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm kidney transplanted | Other | Biological: Blood sampleArm kidney transplanted: all patients who receive kidney transplantation |
| Arm pancreas-kidney transplanted | Other | Biological: Blood sampleArm pancreas-kidney transplanted: all patients who receive pancreas-kidney transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men, women > 18 years old
- Kidney or pancreas-kidney recipients
- Not opposed to research
- With no legal protection
- Affiliated to social security system
Key exclusion criteria (1 listed)
- -Enrollment in an other research protocol, incompatible with the trial according to the investigator
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 |
|---|---|---|
| Blood sample | Biological | Arm kidney transplanted, Arm pancreas-kidney transplanted |
Primary outcome
Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring
Time frame: preoperative period
Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring
Time frame: 45 min after transplant unclamp
Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring
Time frame: Intensice Care Unit admission
Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring
Time frame: 24 hours
Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring
Time frame: 48 hours
5 secondary outcomes
standard coagulation parameters
Time frame: preoperative period
standard coagulation parameters
Time frame: 45 min after transplant unclamp
standard coagulation parameters
Time frame: Intensice Care Unit admission
standard coagulation parameters
Time frame: 24 hours
standard coagulation parameters
Time frame: 48 hours
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 11 Mar 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sample in people with Blood Coagulation, run by Hospices Civils de Lyon at 1 site in France.
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 5 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 11 Mar 2015. 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 France. 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?
Thromboelastogram (ROTEM®) channels (APTEM, EXTEM, INTEM, FIBTEM) monitoring (time frame: preoperative period). The study lists 5 primary outcomes in all. 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 11 Mar 2015.