Coagulopathy During Cardiac SurgeryMultiPOCNCT01826123
Point-of-Care Testing in Coagulopathic Patients Undergoing Cardiac Surgery - a Multicenter Study
A study testing Conventional laboratory testing (Central laboratory) and POC testing in people with Coagulopathy During Cardiac Surgery, run by Goethe University at 4 sites in 2 countries.
Trial summary
Recently, the investigators study group showed in a mono center study that Point of Care (POC) based hemotherapy may reduce transfusion rates of allogenic blood products in perioperative care of coagulopathic cardiac surgery patients. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Coagulopathy During Cardiac Surgery
- What is being tested?
- Conventional laboratory testing (Central laboratory) and POC testing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jul 2013to May 2019
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Step 1:
- Patients scheduled for elective, complex cardiothoracic surgery (combined coronary artery bypass graft and valve surgery, double or triple valve procedures, aortic surgery or redo surgery) with cardiopulmonary bypass (CPB)
- Step 2:
- diffuse bleeding after heparin reversal following extracorporeal circulation or
- intra- or postoperative blood loss exceeding 250 ml/h or 50 ml/10 min
Who cannot join
- Pregnancy
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Germany3 sites
Goethe - University
Frankfurt am Main, Hesse, 60590
University of Heidelberg
Heidelberg, Baden-Wurttemberg, 69120
University of Rostock
Rostock, Mecklenburg-Vorpommern, 18051
About this study
Official title: Point-of-Care Testing - A Prospective, Randomized, Controlled Multicenter Study of Efficacy in Coagulopathic Cardiac Surgery Patients
Recently, the investigators study group showed in a mono center study that Point of Care (POC) based hemotherapy may reduce transfusion rates of allogenic blood products in perioperative care of coagulopathic cardiac surgery patients. The investigators aim to verify the obtained results by conducting this multicenter study.
- Conditions
- Coagulopathy During Cardiac Surgery
- Being tested
- Conventional laboratory testing (Central laboratory), POC testing
- Keywords
- Coagulopathy, Hemorrhage, Cardiac surgery, Point-of-Care testing, POC, ROTEM, multiplate, Multiple electrode aggregometry (MEA)
- 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.
Conventional laboratory testing (Central laboratory)Device
aPTT, INR, fibrinogen concentration, platelet count
POC testingDevice
Also called viscoleastic measures using the ROTEM(R) device and, aggregometric measures using the Multiplate(R) device
ROTEM: Clotting time (CT) in the EXTEM- and INTEM-test, Maximal clot firmness in the FIBTEM-test, Clot Lysis Index (CLI) multiplate: Area under the aggregation curve following stimulation with arachidonic acid (ASA) and Adenosine diphosphate (ADP)
| Study group | Role | What they receive |
|---|---|---|
| Conventional laboratory testing | Active comparator | After being randomized to the group "conventional coagulating testing", hemostatic therapy will be based exclusively on conventional standard coagulation analyses like International normalized ratio (INR), activated prothrombin time (aPTT), fibrinogen and platelet concentration or Activated clotting time (ACT. Analyses will be performed at i) fixed time points (preoperative and at admission to ICU) and ii) variable timepoints depending on the decision of the attending physician. Hemostatic therapy will be based on a specific hemostatic therapy algorithm. Intraoperatively, analyses of ACT (activated clotting time) and INR will be performed following institutional standards using specific POC tests. Receives: Device: Conventional laboratory testing (Central laboratory) |
| POC testing (ROTEM and Multiplate) | Active comparator | After being randomized to the group "POC testing", hemostatic therapy will be based exclusively on POC measures obtained by i) viscoelastic tests (ROTEM(R), TEM international, Munich, Germany) and aggregometric tests (multiplate, ROCHE AG, Grenzach, Germany). Analyses will be performed at variable timepoints depending on the decision of the attending physician. Hemostatic therapy will be based on a specific hemostatic therapy algorithm. Intraoperatively, analyses of ACT (activated clotting time) and INR will be performed following institutional standards using specific POC tests. Receives: Device: POC testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
packed red blood cell concentrate (PRBC) transfusion rate
Number of transfused units of PRBC during the period between inclusion into the study and 24 hours (h) after admission to ICU.
Measured: During the period between inclusion into the study and 24 h after postoperative admission to ICU
Secondary outcomes (15)
Transfusion rate of Fresh Frozen Plasma
Number of transfused units of Fresh Frozen Plasma (FFP)
Measured: During the period between inclusion into the study and 24 h after postoperative admission to ICU
Postoperative Blood loss
Blood loss 6h, 12h and 24h after postoperative admission to ICU
Measured: for up to 24 h after postoperative admission to ICU
Duration of mechanical ventilation
Duration of postoperative mechanical ventilation
Measured: after postoperative admission to ICU, an expected average of 30 hours
Horovitz - indices
PaO2/FiO2 - indices at admission to ICU, as well as 2h, 4h, 12h and 24 h after admission to ICU
Measured: for up to 24 h after postoperative admission to ICU
Incidence of acute renal failure
Incidence of acute renal failure
Measured: during treatment at the intensive care unit, for an average of 3 weeks
Duration of hospitalisation
duration of ICU treatment duration of IMC (Intermediate Care) treatment duration of hospitalisation
Measured: From admission to ICU and up to discharge from the hospital, an expected average of 10 days
rethoracotomies
number of patients with rethoracotomies. Cause for rethoracotomies (surgical or coagulopathic bleeding, pericardium tamponade)
Measured: During the period between inclusion into the study and 24 h after postoperative admission to ICU
Thromboembolic or allergic adverse events
Number of patients with thromboembolic or allergic adverse events.
Measured: for up to 24 h after postoperative admission to ICU
Ventilator - associated pneumonia
Number of patients with ventilator - associated pneumonia
Measured: after postoperative admission to ICU up to discharge from ICU, an expected average of 5 days
Postoperative Sepsis
Number of patients with postoperative Sepsis
Measured: after postoperative admission to ICU up to discharge from ICU, an expected average of 5 days
Transfusion rate of platelet concentrates
Number of transfused platelet concentrates
Measured: During the period between inclusion into the study and 24 h after postoperative admission to ICU
Age of each platelet concentrate
age (days) of each platelet concentrates
Measured: During the period between inclusion into the study and 24 h after postoperative admission to ICU
Amount of infused PCC
Amount of infused prothrombin complex concentrates (PCC)
Measured: During the period between inclusion into the study and 24 h after postoperative admission to ICU
Amount of infused rVIIa
Amount of infused activated coagulation factor VII (rVIIa)
Measured: During the period between inclusion into the study and 24 h after postoperative admission to ICU
Amount of infused fibrinogen concentrate
Amount of infused fibrinogen concentrate
Measured: During the period between inclusion into the study and 24 h after postoperative admission to ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2013 (estimated)
- Study startJul 2013
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (estimated)
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 Coagulopathy During 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian F. Weber, MD, Goethe University
- Investigators
- Christian F Weber, MD, Study director, Goethe UniversityKai Zacharowski, PhD, MD, Principal investigator, Goethe UniversityAlexander Schellhaaß, MD, Study chair, Heidelberg UniversityStefan Hofer, PhD, MD, Study chair, Heidelberg UniversityRoland Freynschlag, MD, Study chair, University of LinzHans Gombotz, PhD, MD, Study chair, University of LinzJan Roesner, MD, Study chair, University of Rostock
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01826123
- Sponsor's protocol ID
- 343/12
- Acronym
- MultiPOC
- Status last verified
- May 2017
- First submitted
- 19 Mar 2013
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Weber CF, Gorlinger K, Meininger D, Herrmann E, Bingold T, Moritz A, Cohn LH, Zacharowski K. Point-of-care testing: a prospective, randomized clinical trial of efficacy in coagulopathic cardiac surgery patients. Anesthesiology. 2012 Sep;117(3):531-47. doi: 10.1097/ALN.0b013e318264c644.
PubMed 22914710Weber CF, Zacharowski K. Perioperative point of care coagulation testing. Dtsch Arztebl Int. 2012 May;109(20):369-75. doi: 10.3238/arztebl.2012.0369. Epub 2012 May 18.
PubMed 22685493
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-of-Care Testing - A Prospective, Randomized, Controlled Multicenter Study of Efficacy in Coagulopathic Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT01826123
- Acronym / sponsor ID
- MultiPOC / 343/12
- Conditions
- Coagulopathy During Cardiac Surgery
- Keywords
- Coagulopathy, Hemorrhage, Cardiac surgery, Point-of-Care testing, POC, ROTEM, multiplate, Multiple electrode aggregometry (MEA)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 8 Apr 2013 (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.
Recently, the investigators study group showed in a mono center study that Point of Care (POC) based hemotherapy may reduce transfusion rates of allogenic blood products in perioperative care of coagulopathic cardiac surgery patients. The investigators aim to verify the obtained results by conducting this multicenter study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional laboratory testing | Active comparator | Device: Conventional laboratory testing (Central laboratory)After being randomized to the group "conventional coagulating testing", hemostatic therapy will be based exclusively on conventional standard coagulation analyses like International normalized ratio (INR), activated prothrombin time (aPTT), fibrinogen and platelet concentration or Activated clotting time (ACT. Analyses will be performed at i) fixed time points (preoperative and at admission to ICU) and ii) variable timepoints depending on the decision of the attending physician. Hemostatic therapy will be based on a specific hemostatic therapy algorithm. Intraoperatively, analyses of ACT (activated clotting time) and INR will be performed following institutional standards using specific POC tests. |
| POC testing (ROTEM and Multiplate) | Active comparator | Device: POC testingAfter being randomized to the group "POC testing", hemostatic therapy will be based exclusively on POC measures obtained by i) viscoelastic tests (ROTEM(R), TEM international, Munich, Germany) and aggregometric tests (multiplate, ROCHE AG, Grenzach, Germany). Analyses will be performed at variable timepoints depending on the decision of the attending physician. Hemostatic therapy will be based on a specific hemostatic therapy algorithm. Intraoperatively, analyses of ACT (activated clotting time) and INR will be performed following institutional standards using specific POC tests. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients scheduled for elective, complex cardiothoracic surgery (combined coronary artery bypass graft and valve surgery, double or triple valve procedures, aortic surgery or redo surgery) with cardiopulmonary bypass (CPB)
- diffuse bleeding after heparin reversal following extracorporeal circulation or
- intra- or postoperative blood loss exceeding 250 ml/h or 50 ml/10 min
Key exclusion criteria (1 listed)
- Pregnancy
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 |
|---|---|---|
| Conventional laboratory testing (Central laboratory)aPTT, INR, fibrinogen concentration, platelet count | Device | Conventional laboratory testing |
| POC testingAlso: viscoleastic measures using the ROTEM(R) device and, aggregometric measures using the Multiplate(R) deviceROTEM: Clotting time (CT) in the EXTEM- and INTEM-test, Maximal clot firmness in the FIBTEM-test, Clot Lysis Index (CLI) multiplate: Area under the aggregation curve following stimulation with arachidonic acid (ASA) and Adenosine diphosphate (ADP) | Device | POC testing (ROTEM and Multiplate) |
Primary outcome
packed red blood cell concentrate (PRBC) transfusion rate
Time frame: During the period between inclusion into the study and 24 h after postoperative admission to ICU
Number of transfused units of PRBC during the period between inclusion into the study and 24 hours (h) after admission to ICU.
15 secondary outcomes
Transfusion rate of Fresh Frozen Plasma
Time frame: During the period between inclusion into the study and 24 h after postoperative admission to ICU
Postoperative Blood loss
Time frame: for up to 24 h after postoperative admission to ICU
Duration of mechanical ventilation
Time frame: after postoperative admission to ICU, an expected average of 30 hours
Horovitz - indices
Time frame: for up to 24 h after postoperative admission to ICU
Incidence of acute renal failure
Time frame: during treatment at the intensive care unit, for an average of 3 weeks
Duration of hospitalisation
Time frame: From admission to ICU and up to discharge from the hospital, an expected average of 10 days
rethoracotomies
Time frame: During the period between inclusion into the study and 24 h after postoperative admission to ICU
Thromboembolic or allergic adverse events
Time frame: for up to 24 h after postoperative admission to ICU
Ventilator - associated pneumonia
Time frame: after postoperative admission to ICU up to discharge from ICU, an expected average of 5 days
Postoperative Sepsis
Time frame: after postoperative admission to ICU up to discharge from ICU, an expected average of 5 days
Transfusion rate of platelet concentrates
Time frame: During the period between inclusion into the study and 24 h after postoperative admission to ICU
Age of each platelet concentrate
Time frame: During the period between inclusion into the study and 24 h after postoperative admission to ICU
Amount of infused PCC
Time frame: During the period between inclusion into the study and 24 h after postoperative admission to ICU
Amount of infused rVIIa
Time frame: During the period between inclusion into the study and 24 h after postoperative admission to ICU
Amount of infused fibrinogen concentrate
Time frame: During the period between inclusion into the study and 24 h after postoperative admission to ICU
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
- Background: PubMed 22914710Weber CF, Gorlinger K, Meininger D, Herrmann E, Bingold T, Moritz A, Cohn LH, Zacharowski K. Point-of-care testing: a prospective, randomized clinical trial of efficacy in coagulopathic cardiac surgery patients. Anesthesiology. 2012 Sep;117(3):531-47. doi: 10.1097/ALN.0b013e318264c644.
- Background: PubMed 22685493Weber CF, Zacharowski K. Perioperative point of care coagulation testing. Dtsch Arztebl Int. 2012 May;109(20):369-75. doi: 10.3238/arztebl.2012.0369. Epub 2012 May 18.
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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, MD study director
Goethe University
Kai Zacharowski, PhD, MD principal investigator
Goethe University
Alexander Schellhaaß, MD study chair
Heidelberg University
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional laboratory testing (Central laboratory) and POC testing in people with Coagulopathy During Cardiac Surgery, run by Goethe University at 4 sites in 2 countries.
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: status not confirmed, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Austria. 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?
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?
packed red blood cell concentrate (PRBC) transfusion rate (time frame: During the period between inclusion into the study and 24 h after postoperative admission to ICU). 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 NCT01826123, 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 4 May 2017.