Extracorporeal Membrane Oxygenation ComplicationNCT03754868
Evaluation of Coagulation Factors and Point-of-care Devices During Veno-venous ECMO Therapy
An observational study of Extracorporeal Membrane Oxygenation Complication and Coagulation Factor Deficiency, run by University Hospital Goettingen at 1 site in Germany.
Trial summary
Hemorrhagic and thromboembolic complications are common in Veno-venous ECMO therapy. The aim of this study is to provide a detailed analysis of the activity of different coagulation factors and changes in functional coagulation measurements as in rotational thrombelastometry and multiple electrode aggregometry in the… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Extracorporeal Membrane Oxygenation Complication, Coagulation Factor Deficiency
- What is being tested?
- Detailed coagulation monitoring
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2014to Jun 2015
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with the need for Veno-venous ECMO therapy treated in a tertiary intensive care unit.
Who may be able to join
- Need for a Veno-venous extracorporeal membrane oxygenation therapy
Who cannot join
- Known coagulation disorders
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of the Activity of Different Coagulation Factors and Monitoring of Coagulation Using Point-of-care Devices During a Veno-venous ECMO Therapy
Hemorrhagic and thromboembolic complications are common in Veno-venous ECMO therapy. The aim of this study is to provide a detailed analysis of the activity of different coagulation factors and changes in functional coagulation measurements as in rotational thrombelastometry and multiple electrode aggregometry in the course of ECMO therapy.
- Being tested
- Detailed coagulation monitoring
- Keywords
- ECMO, Coagulation monitoring, point-of-care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detailed coagulation monitoringDiagnostic test
Monitoring of coagulation using activity of coagulation factors, rotational thrombelastometry and multiple electrode aggregometry
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the activity of coagulation factor II [%] during Veno-venous ECMO therapy
Repeated assessment of the activity of coagulation factor II in % through standard coagulometric methods.
Measured: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Changes in the activity of coagulation factor V [%] during Veno-venous ECMO
Repeated assessment of the activity of coagulation factor V in % through standard coagulometric methods.
Measured: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Changes in the activity of coagulation factor VII [%] during Veno-venous ECMO
Repeated assessment of the activity of coagulation factor VII in % through standard coagulometric methods.
Measured: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Changes in the activity of coagulation factor VIII [%] during Veno-venous ECMO
Repeated assessment of the activity of coagulation factor VIII in % through standard coagulometric methods.
Measured: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Changes in the activity of coagulation factor IX [%] during Veno-venous ECMO
Repeated assessment of the activity of coagulation factor IX in % through standard coagulometric methods.
Measured: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Changes in the activity of coagulation factor X [%] during Veno-venous ECMO
Repeated assessment of the activity of coagulation factor X in % through standard coagulometric methods.
Measured: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Changes in the activity of coagulation factor XII [%] during Veno-venous ECMO
Repeated assessment of the activity of coagulation factor XII in % through standard coagulometric methods.
Measured: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Changes in the activity of coagulation factor XIII [%] during Veno-venous ECMO
Repeated assessment of the activity of coagulation factor XIII in % through standard coagulometric methods.
Measured: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Secondary outcomes (35)
vWF-Antigen
Measurement of the vWF-Antigen
Measured: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Changes in the vWF:Ristocetin-Cofaktor-Activity in % during Veno-venous ECMO therapy
Repeated assessments of the vWF:Ristocetin-Cofaktor-Activity [%]
Measured: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Changes in CT-EXTEM
Changes in clotting time (CT) in the extrinsically activated assay (EXTEM) of rotational thrombelastometry (ROTEM), results were noted in seconds.
Measured: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in CT-INTEM
Changes in clotting time (CT) in the intrinsically activated assay (INTEM) of rotational thrombelastometry (ROTEM), results were noted in seconds.
Measured: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in CT-FIBTEM
Changes in clotting time (CT) in the extrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of Cytochalasin D to inhibit platelet aggregation (FIBTEM), results were noted in seconds.
Measured: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in CT-HEPTEM
Changes in clotting time (CT) in the intrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of heparin to eliminate heparin effects (HEPTEM), results were noted in seconds.
Measured: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in CFT-EXTEM
Changes in clot formation time (CFT) in the extrinsically activated assay (EXTEM) of rotational thrombelastometry (ROTEM), results were noted in seconds.
Measured: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in CFT-INTEM
Changes in clot formation time (CFT) in the intrinsically activated assay (INTEM) of rotational thrombelastometry (ROTEM), results were noted in seconds.
Measured: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in CFT-FIBTEM
Changes in clot formation time (CFT) in the extrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of Cytochalasin D to inhibit platelet aggregation (FIBTEM), results were noted in seconds.
Measured: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in CFT-HEPTEM
Changes in clot formation time (CFT) in the intrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of heparin to eliminate heparin effects (HEPTEM), results were noted in seconds.
Measured: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in MCF-EXTEM
Changes in maximum clot firmness (MCF) in the extrinsically activated assay (EXTEM) of rotational thrombelastometry (ROTEM), results were noted in millimeters.
Measured: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in MCF-INTEM
Changes in maximum clot firmness (MCF) in the intrinsically activated assay (INTEM) of rotational thrombelastometry (ROTEM), results were noted in millimeters.
Measured: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in MCF-FIBTEM
Changes in maximum clot firmness (MCF) in the extrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of Cytochalasin D to inhibit platelet aggregation (FIBTEM), results were noted in millimeters.
Measured: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in MCF-HEPTEM
Changes in maximum clot firmness (MCF) in the intrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of heparin to eliminate heparin effects (HEPTEM), results were noted in millimeters.
Measured: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in Alpha angle-EXTEM
Changes in Alpha angle in the extrinsically activated assay (EXTEM) of rotational thrombelastometry (ROTEM), results were noted in degree.
Measured: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in Alpha angle-INTEM
Changes in Alpha angle in the intrinsically activated assay (INTEM) of rotational thrombelastometry (ROTEM), results were noted in degree.
Measured: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in Alpha angle-FIBTEM
Changes in Alpha angle in the extrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of Cytochalasin D to inhibit platelet aggregation (FIBTEM), results were noted in degree.
Measured: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in Alpha angle-HEPTEM
Changes in Alpha angle in the intrinsically activated assay of rotational thrombelastometry (ROTEM) with the addition of heparin to eliminate heparin effects (HEPTEM), results were noted in degree.
Measured: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in arachidonic acid induced platelet aggregation assessed by multiple elcetrode aggregometry (MEA)(ASPItest)
Platelet aggregation after stimulation with arachidonic acid was recorded in aggregational units (AU).
Measured: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in adenosine diphosphate (ADP) induced platelet aggregation assessed by multiple elcetrode aggregometry (MEA)(ADPtest)
Platelet aggregation after stimulation with ADP was recorded in aggregational units (AU).
Measured: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in thrombin-receptor activating peptide (TRAP) induced platelet aggregation assessed by multiple elcetrode aggregometry (MEA)(TRAPtest)
Platelet aggregation after stimulation with TRAP was recorded in aggregational units (AU).
Measured: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Light transmission aggregometry
Measurement of platelet function
Measured: 6 hours and 7 days after canulation
Quick
Measurement of Quick in %
Measured: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
activated partial thromboplastin time (aPTT)
Measurement of aPTT in seconds
Measured: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
Fibrinogen
Measurement of fibrinogen concentration in mg/dl
Measured: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
Platelet count
Measurement of platelet count/µl
Measured: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
activated clotting time (ACT)
Measurement of ACT in seconds
Measured: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
Antithrombin III (ATIII)
Measurement of ATIII in %
Measured: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
Measurement of Anti-Xa-Activity in %
Measurement of Anti-Xa-Activity by chromogenic assay to determine heparin effect
Measured: Pre-canulation, 6 hours, 1 day, 2 days, 3 days, 4 days, 5, days, 6 days, 7 days, 10, days, 11 days 14 days, 17 days, 19 days and 21 days after canulation
D-Dimers
Measurement of D-Dimers
Measured: Pre-canulation, 6 hours, 1 day, 2 days, 3 days, 4 days, 5, days, 6 days, 7 days, 10, days, 11 days 14 days, 17 days, 19 days and 21 days after canulation
hemoglobin
hemoglobin concentration in g/dl
Measured: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
leucocyte count
leucocyte count/µl
Measured: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
Hemorrhagic complications
Structured documentation of hemorrhagic complications
Measured: Daily from day 1-21
Thrombotic complications
Structured documentation of thrombotic complications
Measured: Daily from day 1-21
Oxygenator State
Structured documentation of the state of the oxygenator including search for thrombotic material
Measured: Daily from day 1-21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2018
- Study startJul 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Extracorporeal Membrane Oxygenation ComplicationStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Goettingen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saskia Wand, University Hospital Goettingen
- Investigators
- Onnen Moerer, Prof., Principal investigator, Department of Anesthesiology, University Medical Center Goettingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03754868
- Sponsor's protocol ID
- 19/5/13
- Status last verified
- Nov 2018
- First submitted
- 7 Nov 2018
- Last updated
- 27 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Activity of Different Coagulation Factors and Monitoring of Coagulation Using Point-of-care Devices During a Veno-venous ECMO Therapy
- ClinicalTrials.gov ID
- NCT03754868
- Acronym / sponsor ID
- 19/5/13
- Keywords
- ECMO, Coagulation monitoring, point-of-care
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital GoettingenUniversity, hospital or other
- Study start
- Jul 2014 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 27 Nov 2018 (actual)
- 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.
Hemorrhagic and thromboembolic complications are common in Veno-venous ECMO therapy. The aim of this study is to provide a detailed analysis of the activity of different coagulation factors and changes in functional coagulation measurements as in rotational thrombelastometry and multiple electrode aggregometry in the course of ECMO therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with the need for Veno-venous ECMO therapy treated in a tertiary intensive care unit.
Key inclusion criteria (1 listed)
- Need for a Veno-venous extracorporeal membrane oxygenation therapy
Key exclusion criteria (2 listed)
- Known coagulation disorders
- Refusal to participate
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 |
|---|---|---|
| Detailed coagulation monitoringMonitoring of coagulation using activity of coagulation factors, rotational thrombelastometry and multiple electrode aggregometry | Diagnostic test | – |
Primary outcome
Changes in the activity of coagulation factor II [%] during Veno-venous ECMO therapy
Time frame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Repeated assessment of the activity of coagulation factor II in % through standard coagulometric methods.
Changes in the activity of coagulation factor V [%] during Veno-venous ECMO
Time frame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Repeated assessment of the activity of coagulation factor V in % through standard coagulometric methods.
Changes in the activity of coagulation factor VII [%] during Veno-venous ECMO
Time frame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Repeated assessment of the activity of coagulation factor VII in % through standard coagulometric methods.
Changes in the activity of coagulation factor VIII [%] during Veno-venous ECMO
Time frame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Repeated assessment of the activity of coagulation factor VIII in % through standard coagulometric methods.
Changes in the activity of coagulation factor IX [%] during Veno-venous ECMO
Time frame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Repeated assessment of the activity of coagulation factor IX in % through standard coagulometric methods.
Changes in the activity of coagulation factor X [%] during Veno-venous ECMO
Time frame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Repeated assessment of the activity of coagulation factor X in % through standard coagulometric methods.
Changes in the activity of coagulation factor XII [%] during Veno-venous ECMO
Time frame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Repeated assessment of the activity of coagulation factor XII in % through standard coagulometric methods.
Changes in the activity of coagulation factor XIII [%] during Veno-venous ECMO
Time frame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Repeated assessment of the activity of coagulation factor XIII in % through standard coagulometric methods.
35 secondary outcomes
vWF-Antigen
Time frame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Changes in the vWF:Ristocetin-Cofaktor-Activity in % during Veno-venous ECMO therapy
Time frame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation
Changes in CT-EXTEM
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in CT-INTEM
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in CT-FIBTEM
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in CT-HEPTEM
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in CFT-EXTEM
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in CFT-INTEM
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in CFT-FIBTEM
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in CFT-HEPTEM
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in MCF-EXTEM
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in MCF-INTEM
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in MCF-FIBTEM
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in MCF-HEPTEM
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in Alpha angle-EXTEM
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in Alpha angle-INTEM
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in Alpha angle-FIBTEM
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in Alpha angle-HEPTEM
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in arachidonic acid induced platelet aggregation assessed by multiple elcetrode aggregometry (MEA)(ASPItest)
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in adenosine diphosphate (ADP) induced platelet aggregation assessed by multiple elcetrode aggregometry (MEA)(ADPtest)
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Changes in thrombin-receptor activating peptide (TRAP) induced platelet aggregation assessed by multiple elcetrode aggregometry (MEA)(TRAPtest)
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 4 days, 7 days and 11 days after canulation
Light transmission aggregometry
Time frame: 6 hours and 7 days after canulation
Quick
Time frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
activated partial thromboplastin time (aPTT)
Time frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
Fibrinogen
Time frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
Platelet count
Time frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
activated clotting time (ACT)
Time frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
Antithrombin III (ATIII)
Time frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
Measurement of Anti-Xa-Activity in %
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 3 days, 4 days, 5, days, 6 days, 7 days, 10, days, 11 days 14 days, 17 days, 19 days and 21 days after canulation
D-Dimers
Time frame: Pre-canulation, 6 hours, 1 day, 2 days, 3 days, 4 days, 5, days, 6 days, 7 days, 10, days, 11 days 14 days, 17 days, 19 days and 21 days after canulation
hemoglobin
Time frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
leucocyte count
Time frame: Pre-canulation, 6 hours and daily from day 1- day 21after canulation
Hemorrhagic complications
Time frame: Daily from day 1-21
Thrombotic complications
Time frame: Daily from day 1-21
Oxygenator State
Time frame: Daily from day 1-21
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 27 Nov 2018.
- Individual participant dataSharing planned: Undecided
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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.
Onnen Moerer, Prof. principal investigator
Department of Anesthesiology, University Medical Center Goettingen
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 Extracorporeal Membrane Oxygenation Complication and Coagulation Factor Deficiency, run by University Hospital Goettingen 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 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 27 Nov 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?
Changes in the activity of coagulation factor II [%] during Veno-venous ECMO therapy (time frame: Pre-canulation and 6 hours, 1 day, 3 days, 7 days, 11 days, 15 days and 21 days after canulation). The study lists 8 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 27 Nov 2018.