Aortic AneurysmPhase 2NCT00701142
Haemocomplettan® P During Aortic Replacement
A Phase 2 study testing Haemocomplettan® P and Saline solution in people with Aortic Aneurysm, run by CSL Behring at 1 site in Germany.
Trial summary
The primary purpose is to show that administration of Haemocomplettan® P significantly reduces the amount of blood products needed during aortic surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm
- What is being tested?
- Haemocomplettan® P and Saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2008to Apr 2010
- Phase
- Phase 2
- 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
- Eighteen years of age or older
- Undergoing elective thoracoabdominal aortic replacement surgery (TAAA) or thoracic aortic replacement surgery (TAA)
- Understood and willingly given written informed consent (German language) to participate following an explanation of study background, restrictions, and procedures
- Experience clinically relevant bleeding of the microvasculature following removal of CPB during surgery
Who cannot join
- Positive pregnancy test, pregnancy or lactation
- Women of child bearing age not using a medically approved method of contraception during the study
- Previous aortic replacement at the same aortic site (redo surgeries)
- Undergoing an emergency operation
- Proof or suspicion of a congenital or acquired coagulation disorder (e.g. VWD or via severe liver disease)
- Myocardial Infarction (MI) or apoplexy in the 2 months preceding study surgery
Show all 15Show fewer
- ASA administration in the 3 days preceding study surgery, and a pathological (<74.5 U) ASPI Multiplate® test immediately preceding surgery begin
- Clopidogrel administration in the 5 days preceding study surgery, and a pathological (<31.1 U) ADP/PG Multiplate® test immediately preceding surgery begin
- Tirofiban administration in the 2 days preceding study surgery, and a pathological (<94.1 U) TRAP Multiplate® test immediately preceding surgery begin
- Phenprocoumon administration in the 5 days preceding study surgery, and an INR > 1.28 immediately preceding surgery begin
- Participation in another clinical study in the 4 weeks preceding aortic replacement
- Sensitivity to any of the components of study medication, or to MPs with a similar chemical structure to any of the components of study medication
- Any indication that the restrictions or procedures of the study may not be adhered to (e.g. an uncooperative attitude)
- Any indication that the study restrictions, procedures, or consequences therein have not been considered or understood, such that informed consent cannot be convincingly given
- Multiple morbidities, with a notably constrained remaining length of life
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Haemocomplettan® P in Patients Experiencing Acute Bleeding While Undergoing Aortic Replacement Surgery
The primary purpose is to show that administration of Haemocomplettan® P significantly reduces the amount of blood products needed during aortic surgery.
- Conditions
- Aortic Aneurysm
- Being tested
- Haemocomplettan® P, Saline solution
- Medical subject headings
- Aortic Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haemocomplettan® PBiological
Also called RiaSTAP
Single intravenous infusion
Saline solutionBiological
Single intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| Haemocomplettan® P | Active comparator | Intravenous infusion during aortic surgery Receives: Biological: Haemocomplettan® P |
| Saline solution | Placebo comparator | Not described Receives: Biological: Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined number of units of allogeneic blood products (platelets + FFP + RBCs) administered to subjects.
Measured: From administration of Haemocomplettan® P until 24 hours later
Secondary outcomes (4)
Proportion of subjects that receive no allogeneic blood products (neither platelets, FFP, nor RBCs)
Measured: From administration of Haemocomplettan® P until 24 hours later
Duration of stay in ICU
Measured: Last suture of initial surgery to end of ICU stay
Duration of hospital stay
Measured: Last suture of initial surgery to end of hospital stay
Mortality
Measured: 45 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionMar 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Aortic AneurysmStudies of the same condition, open and under way.
- More trials run by CSL BehringThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- CSL Behring
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Niels Rahe-Meyer, Dr. Dr., Principal investigator, Abteilung Anästhesiologie, Carl-Neuberg-Strasse 1 / K5, 30177 Hannover
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00701142
- Sponsor's protocol ID
- 1470
- Other IDs
- BI3023_2002, 2007-004612-31
- Status last verified
- Feb 2011
- First submitted
- 16 Jun 2008
- Last updated
- 20 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Rahe-Meyer N, Solomon C, Hanke A, Schmidt DS, Knoerzer D, Hochleitner G, Sorensen B, Hagl C, Pichlmaier M. Effects of fibrinogen concentrate as first-line therapy during major aortic replacement surgery: a randomized, placebo-controlled trial. Anesthesiology. 2013 Jan;118(1):40-50. doi: 10.1097/ALN.0b013e3182715d4d.
PubMed 23249928Rahe-Meyer N, Hanke A, Schmidt DS, Hagl C, Pichlmaier M. Fibrinogen concentrate reduces intraoperative bleeding when used as first-line hemostatic therapy during major aortic replacement surgery: results from a randomized, placebo-controlled trial. J Thorac Cardiovasc Surg. 2013 Mar;145(3 Suppl):S178-85. doi: 10.1016/j.jtcvs.2012.12.083.
PubMed 23410777Schochl H, Posch A, Hanke A, Voelckel W, Solomon C. High-dose fibrinogen concentrate for haemostatic therapy of a major trauma patient with recent clopidogrel and aspirin intake. Scand J Clin Lab Invest. 2010 Oct;70(6):453-7. doi: 10.3109/00365513.2010.500396.
PubMed 20624109
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haemocomplettan® P in Patients Experiencing Acute Bleeding While Undergoing Aortic Replacement Surgery
- ClinicalTrials.gov ID
- NCT00701142
- Acronym / sponsor ID
- 1470
- Conditions
- Aortic Aneurysm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- CSL BehringIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 19 Jun 2008 (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 primary purpose is to show that administration of Haemocomplettan® P significantly reduces the amount of blood products needed during aortic surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Haemocomplettan® P | Active comparator | Biological: Haemocomplettan® PIntravenous infusion during aortic surgery |
| Saline solution | Placebo comparator | Biological: Saline solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Eighteen years of age or older
- Undergoing elective thoracoabdominal aortic replacement surgery (TAAA) or thoracic aortic replacement surgery (TAA)
- Understood and willingly given written informed consent (German language) to participate following an explanation of study background, restrictions, and procedures
- Experience clinically relevant bleeding of the microvasculature following removal of CPB during surgery
Key exclusion criteria (15 listed)
- Positive pregnancy test, pregnancy or lactation
- Women of child bearing age not using a medically approved method of contraception during the study
- Previous aortic replacement at the same aortic site (redo surgeries)
- Undergoing an emergency operation
- Proof or suspicion of a congenital or acquired coagulation disorder (e.g. VWD or via severe liver disease)
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 |
|---|---|---|
| Haemocomplettan® PAlso: RiaSTAPSingle intravenous infusion | Biological | Haemocomplettan® P |
| Saline solutionSingle intravenous infusion | Biological | Saline solution |
Primary outcome
Combined number of units of allogeneic blood products (platelets + FFP + RBCs) administered to subjects.
Time frame: From administration of Haemocomplettan® P until 24 hours later
4 secondary outcomes
Proportion of subjects that receive no allogeneic blood products (neither platelets, FFP, nor RBCs)
Time frame: From administration of Haemocomplettan® P until 24 hours later
Duration of stay in ICU
Time frame: Last suture of initial surgery to end of ICU stay
Duration of hospital stay
Time frame: Last suture of initial surgery to end of hospital stay
Mortality
Time frame: 45 days post surgery
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 20 Sep 2013.
- Results publication: PubMed 23249928Rahe-Meyer N, Solomon C, Hanke A, Schmidt DS, Knoerzer D, Hochleitner G, Sorensen B, Hagl C, Pichlmaier M. Effects of fibrinogen concentrate as first-line therapy during major aortic replacement surgery: a randomized, placebo-controlled trial. Anesthesiology. 2013 Jan;118(1):40-50. doi: 10.1097/ALN.0b013e3182715d4d.
- Derived from this study: PubMed 23410777Rahe-Meyer N, Hanke A, Schmidt DS, Hagl C, Pichlmaier M. Fibrinogen concentrate reduces intraoperative bleeding when used as first-line hemostatic therapy during major aortic replacement surgery: results from a randomized, placebo-controlled trial. J Thorac Cardiovasc Surg. 2013 Mar;145(3 Suppl):S178-85. doi: 10.1016/j.jtcvs.2012.12.083.
- Derived from this study: PubMed 20624109Schochl H, Posch A, Hanke A, Voelckel W, Solomon C. High-dose fibrinogen concentrate for haemostatic therapy of a major trauma patient with recent clopidogrel and aspirin intake. Scand J Clin Lab Invest. 2010 Oct;70(6):453-7. doi: 10.3109/00365513.2010.500396.
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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.
Niels Rahe-Meyer, Dr. Dr. principal investigator
Abteilung Anästhesiologie, Carl-Neuberg-Strasse 1 / K5, 30177 Hannover
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Haemocomplettan® P and Saline solution in people with Aortic Aneurysm, run by CSL Behring 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 4 inclusion and 15 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 20 Sep 2013. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Combined number of units of allogeneic blood products (platelets + FFP + RBCs) administered to subjects. (time frame: From administration of Haemocomplettan® P until 24 hours later). 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 NCT00701142, which also lists 3 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 20 Sep 2013.