Chest Tube OutputHEART-PoCNCT01402739
Algorithm-Guided Transfusions in Cardiac Surgery Patients for Reduction of Drainage Blood Losses
A study testing Point of Care Coagulation Monitoring Guided Transfusion Algorithm and standard coagulation monitoring guided transfusion algorithm in people with Chest Tube Output and Allogeneic Blood Transfusions, run by Michael Sander at 1 site in Germany.
Trial summary
Cardiac surgery patients have a risk to need allogeneic blood transfusions that depends on several risk factors, e.g. the type of surgery, concomitant medication with anticoagulants, and postoperative chest tube output. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chest Tube Output, Allogeneic Blood Transfusions
- What is being tested?
- Point of Care Coagulation Monitoring Guided Transfusion Algorithm and standard coagulation monitoring guided transfusion algorithm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2011to Jun 2015
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective cardiac surgery patient requiring cardiopulmonary bypass
- moderate or high transfusion risk
- signed informed consent
Who cannot join
- age <18 or >80 years
- known hemophilia
- known thrombophilia
- known thrombocytopathy
- hereditary or acquired coagulation disorder
- active endocarditis
Show all 20Show fewer
- ejection fraction <30%
- BSA < 1.8 sqm
- planned aortic arch surgery
- preoperative thrombocytopenia <150/nl
- underlying hemostaseological disease
- preoperative anemia
- liver cirrhosis Child B or higher
- preoperative creatinine > 2mg/dl
- terminal renal insufficiency requiring dialysis
- vitamin k antagonists during 5 days prior to surgery
- pregnant or breast-feeding women
- known allergy against allogeneic blood products or coagulation factors
- refusal of blood transfusions
- any concomitant investigational agent or participation in another trial
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology CCM/CVK Charité Universitätsmedizin Berlin
Berlin, State of Berlin, 10117
About this study
Official title: Monocentric Pilot Study of Algorithm-Guided Transfusions in Cardiac Surgery Patients for Reduction of Drainage Blood Losses
Cardiac surgery patients have a risk to need allogeneic blood transfusions that depends on several risk factors, e.g. the type of surgery, concomitant medication with anticoagulants, and postoperative chest tube output. Allogeneic blood transfusion is associated with transfusion reactions, infection transmission, and postoperative morbidity and mortality. The aim of this study is to investigate, whether cardiac surgery patients have a reduced postoperative chest tube output and transfusion need when using a point-of-care guided transfusion algorithm compared to standard of care transfusion protocols.
Read the detailed description
Cardiac surgery patients have a risk to need allogeneic blood transfusions that depends on several risk factors, e.g. the type of surgery, concomitant medication with anticoagulants, and postoperative chest tube output. Allogeneic blood transfusion is associated with transfusion reactions, infection transmission, and postoperative morbidity and mortality. The aim of this study is to investigate, whether cardiac surgery patients have a reduced postoperative chest tube output and transfusion need when using a point-of-care guided transfusion algorithm compared to standard of care transfusion protocols .
- Conditions
- Chest Tube Output, Allogeneic Blood Transfusions
- Being tested
- Point of Care Coagulation Monitoring Guided Transfusion Algorithm, standard coagulation monitoring guided transfusion algorithm
- Keywords
- PoC, ROTEM, Multiplate, transfusion, cardiac surgery, drainage blood loss, chest tube output
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point of Care Coagulation Monitoring Guided Transfusion AlgorithmOther
Also called ROTEM delta, Multiplate, ABL 725
(thromboelastometry, aggregometry, blood gas analysis)
standard coagulation monitoring guided transfusion algorithmOther
aPTT, ACT, platelet count, hemoglobin, fibrinogen
| Study group | Role | What they receive |
|---|---|---|
| PoC algorithm guided transfusions | Experimental | experimental arm Receives: Other: Point of Care Coagulation Monitoring Guided Transfusion Algorithm |
| standard of care transfusions | Active comparator | control arm Receives: Other: standard coagulation monitoring guided transfusion algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
chest tube output
Measured: 24 hours
Secondary outcomes (4)
need of allogeneic blood transfusions
Measured: 24 hours
course of conventional coagulation parameters (aPTT, TPZ, fibrinogen, FXIII, ACT)
Measured: 24 hours
duration of mechanical ventilation
Measured: hours (average)
incidence of RRT
or until hospital discharge, whatever is earlier
Measured: during 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2011 (estimated)
- Study startAug 2011
- Primary completionJun 2015
- Study completionJun 2015
Why it stopped: Study terminated prematurely due to futility
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 Chest Tube OutputStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael Sander
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Michael Sander, Charite University, Berlin, Germany
- Investigators
- Michael Sander, MD, Principal investigator, Dept. of Anesthesiology CCM/CVK Charité Universitätsmedizin BerlinClaudia D Spies, MD, Study chair, Dept. of Anesthesiology CCM/CVK Charité Universitätsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01402739
- Sponsor's protocol ID
- HEART-PoC
- Acronym
- HEART-PoC
- Status last verified
- Jun 2015
- First submitted
- 25 Jul 2011
- Last updated
- 15 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kvisselgaard AD, Wolthers SA, Wikkelso AJ, Holst LB, Drivenes B, Afshari A. Thromboelastography (TEG) or thromboelastometry (ROTEM) to monitor haemostatic treatment versus usual care in adults or children with bleeding. Cochrane Database Syst Rev. 2026 May 18;5(5):CD007871. doi: 10.1002/14651858.CD007871.pub4.
PubMed 42145275Lehmann F, Rau J, Malcolm B, Sander M, von Heymann C, Moormann T, Geyer T, Balzer F, Wernecke KD, Kaufner L. Why does a point of care guided transfusion algorithm not improve blood loss and transfusion practice in patients undergoing high-risk cardiac surgery? A prospective randomized controlled pilot study. BMC Anesthesiol. 2019 Feb 18;19(1):24. doi: 10.1186/s12871-019-0689-7.
PubMed 30777015
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric Pilot Study of Algorithm-Guided Transfusions in Cardiac Surgery Patients for Reduction of Drainage Blood Losses
- ClinicalTrials.gov ID
- NCT01402739
- Acronym / sponsor ID
- HEART-PoC / HEART-PoC
- Conditions
- Chest Tube Output, Allogeneic Blood Transfusions
- Keywords
- PoC, ROTEM, Multiplate, transfusion, cardiac surgery, drainage blood loss, chest tube output
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated prematurely due to futility
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Michael SanderUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 26 Jul 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.
Cardiac surgery patients have a risk to need allogeneic blood transfusions that depends on several risk factors, e.g. the type of surgery, concomitant medication with anticoagulants, and postoperative chest tube output. Allogeneic blood transfusion is associated with transfusion reactions, infection transmission, and postoperative morbidity and mortality. The aim of this study is to investigate, whether cardiac surgery patients have a reduced postoperative chest tube output and transfusion need when using a point-of-care guided transfusion algorithm compared to standard of care transfusion protocols.
Detailed description
Cardiac surgery patients have a risk to need allogeneic blood transfusions that depends on several risk factors, e.g. the type of surgery, concomitant medication with anticoagulants, and postoperative chest tube output. Allogeneic blood transfusion is associated with transfusion reactions, infection transmission, and postoperative morbidity and mortality. The aim of this study is to investigate, whether cardiac surgery patients have a reduced postoperative chest tube output and transfusion need when using a point-of-care guided transfusion algorithm compared to standard of care transfusion protocols .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PoC algorithm guided transfusions | Experimental | Other: Point of Care Coagulation Monitoring Guided Transfusion Algorithmexperimental arm |
| standard of care transfusions | Active comparator | Other: standard coagulation monitoring guided transfusion algorithmcontrol arm |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- elective cardiac surgery patient requiring cardiopulmonary bypass
- moderate or high transfusion risk
- signed informed consent
Key exclusion criteria (20 listed)
- age <18 or >80 years
- known hemophilia
- known thrombophilia
- known thrombocytopathy
- hereditary or acquired coagulation disorder
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 |
|---|---|---|
| Point of Care Coagulation Monitoring Guided Transfusion AlgorithmAlso: ROTEM delta, Multiplate, ABL 725(thromboelastometry, aggregometry, blood gas analysis) | Other | PoC algorithm guided transfusions |
| standard coagulation monitoring guided transfusion algorithmaPTT, ACT, platelet count, hemoglobin, fibrinogen | Other | standard of care transfusions |
Primary outcome
chest tube output
Time frame: 24 hours
4 secondary outcomes
need of allogeneic blood transfusions
Time frame: 24 hours
course of conventional coagulation parameters (aPTT, TPZ, fibrinogen, FXIII, ACT)
Time frame: 24 hours
duration of mechanical ventilation
Time frame: hours (average)
incidence of RRT
Time frame: during 30 days
Results and safety
The study was stopped early (reason given: Study terminated prematurely due to futility). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2015.
- Derived from this study: PubMed 42145275Kvisselgaard AD, Wolthers SA, Wikkelso AJ, Holst LB, Drivenes B, Afshari A. Thromboelastography (TEG) or thromboelastometry (ROTEM) to monitor haemostatic treatment versus usual care in adults or children with bleeding. Cochrane Database Syst Rev. 2026 May 18;5(5):CD007871. doi: 10.1002/14651858.CD007871.pub4.
- Derived from this study: PubMed 30777015Lehmann F, Rau J, Malcolm B, Sander M, von Heymann C, Moormann T, Geyer T, Balzer F, Wernecke KD, Kaufner L. Why does a point of care guided transfusion algorithm not improve blood loss and transfusion practice in patients undergoing high-risk cardiac surgery? A prospective randomized controlled pilot study. BMC Anesthesiol. 2019 Feb 18;19(1):24. doi: 10.1186/s12871-019-0689-7.
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.
Michael Sander, MD principal investigator
Dept. of Anesthesiology CCM/CVK Charité Universitätsmedizin Berlin
Claudia D Spies, MD study chair
Dept. of Anesthesiology CCM/CVK Charité Universitätsmedizin Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point of Care Coagulation Monitoring Guided Transfusion Algorithm and standard coagulation monitoring guided transfusion algorithm in people with Chest Tube Output and Allogeneic Blood Transfusions, run by Michael Sander 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 3 inclusion and 20 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: stopped early, as of the sponsor's last update on 15 Jun 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 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 was stopped early (reason given: Study terminated prematurely due to futility). 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?
chest tube output (time frame: 24 hours). 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 NCT01402739, 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 15 Jun 2015.