Blood Loss, SurgicalPhase 2HAVASNCT00618293
Haemate HS in Patients With Severe Bleeding Undergoing Valve Replacement Due to Aortic Stenosis
A Phase 2 study testing Haemate HS and NaCl-solution in people with Blood Loss, Surgical, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
Evaluation of efficacy by determination of transfusion requirements and safety by determination of adverse events in administration of Von Willebrand factor concentrate F VIII (Haemate). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blood Loss, Surgical
- What is being tested?
- Haemate HS and NaCl-solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2008to Jul 2011
- 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
- patients with isolated valvular aortic stenosis or combined aortic-valve defect with prevailing stenosis with severe bleeding during aortic-valve replacement
- Caucasian
- written informed consent (Classification of bleeding as "normal", "moderate" or "excessive" by the surgeon.Classification as excessive leads to recruitment)
Who cannot join
- active endocarditis
- history suggestive for inherited oe acquired bleeding disorder
- concomitant coronary heart disease
- agents impairing platelet function up to 14 days before surgery
- Pregnancy
- inherited platelet function
Show all 12Show fewer
- known intolerance against HAEMATE HS
- previous thromboembolic complications
- Hepatitis B, C or HIV infection
- previous chemotherapy
- emergency surgery within the last 7 days
- weight < 50 kg and > 100 kg
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Study in Evaluation of the Efficacy and Safety of Haemate HS in This Clinical Setting (Patients With Severe Bleeding Undergoing Valve Replacement Due to Aortic Stenosis)
Evaluation of efficacy by determination of transfusion requirements and safety by determination of adverse events in administration of Von Willebrand factor concentrate F VIII (Haemate).
- Conditions
- Blood Loss, Surgical
- Being tested
- Haemate HS, NaCl-solution
- Keywords
- intraoperative bleeding, aortic-valve replacement, aortic stenosis, Von Willebrand, HEAMATE
- Medical subject headings
- Blood Loss, Surgical, Aortic Valve Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Haemate HSDrug
intravenous infusion of Haemate (dosage dependent on body weight)
NaCl-solutionOther
intravenous infusion of 0.9%NaCl-Solution
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | intravenous infusion of Haemate (dosage dependent on body weight) Receives: Drug: Haemate HS |
| 2 | Placebo comparator | intravenous infusion of 0.9% NaCl solution Receives: Other: NaCl-solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
intra- and postoperative transfusion requirements of packed red cells, platelet concentrates and fresh frozen plasma according to defined transfusion thresholds
Measured: begin of surgery and 48h after administration of medication
Secondary outcomes (1)
Assessment of adverse events and viral safety
Measured: 1.perioperative 2. during hospital admission 3. within 90 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJul 2010 (estimated)
- Study completionJul 2011
Why it stopped: No patient met the criteria for inclusion in the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood Loss, SurgicalStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Collaborators
- CSL Behring
- Investigators
- Peter Feindt, Prof. Dr. med., Principal investigator, Klinik für Kardiovaskuläre Chirurgie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00618293
- Sponsor's protocol ID
- BI8021_5101
- Acronym
- HAVAS
- Status last verified
- Jan 2012
- First submitted
- 8 Feb 2008
- Last updated
- 5 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study in Evaluation of the Efficacy and Safety of Haemate HS in This Clinical Setting (Patients With Severe Bleeding Undergoing Valve Replacement Due to Aortic Stenosis)
- ClinicalTrials.gov ID
- NCT00618293
- Acronym / sponsor ID
- HAVAS / BI8021_5101
- Conditions
- Blood Loss, Surgical
- Keywords
- intraoperative bleeding, aortic-valve replacement, aortic stenosis, Von Willebrand, HEAMATE
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patient met the criteria for inclusion in the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Collaborators
- CSL Behring
- Study start
- Jan 2008
- Primary completion
- Jul 2010 (estimated)
- Study completion
- Jul 2011 (actual)
- First posted
- 20 Feb 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.
Evaluation of efficacy by determination of transfusion requirements and safety by determination of adverse events in administration of Von Willebrand factor concentrate F VIII (Haemate).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: Haemate HSintravenous infusion of Haemate (dosage dependent on body weight) |
| 2 | Placebo comparator | Other: NaCl-solutionintravenous infusion of 0.9% NaCl solution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients with isolated valvular aortic stenosis or combined aortic-valve defect with prevailing stenosis with severe bleeding during aortic-valve replacement
- Caucasian
- written informed consent (Classification of bleeding as "normal", "moderate" or "excessive" by the surgeon.Classification as excessive leads to recruitment)
Key exclusion criteria (12 listed)
- active endocarditis
- history suggestive for inherited oe acquired bleeding disorder
- concomitant coronary heart disease
- agents impairing platelet function up to 14 days before surgery
- 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 |
|---|---|---|
| Haemate HSintravenous infusion of Haemate (dosage dependent on body weight) | Drug | 1 |
| NaCl-solutionintravenous infusion of 0.9%NaCl-Solution | Other | 2 |
Primary outcome
intra- and postoperative transfusion requirements of packed red cells, platelet concentrates and fresh frozen plasma according to defined transfusion thresholds
Time frame: begin of surgery and 48h after administration of medication
1 secondary outcome
Assessment of adverse events and viral safety
Time frame: 1.perioperative 2. during hospital admission 3. within 90 days after surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2012.
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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.
Peter Feindt, Prof. Dr. med. principal investigator
Klinik für Kardiovaskuläre Chirurgie
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 Haemate HS and NaCl-solution in people with Blood Loss, Surgical, run by Heinrich-Heine University, Duesseldorf 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 12 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: withdrawn, as of the sponsor's last update on 5 Jan 2012. 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 was withdrawn before enrolling participants, so there are no results.
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?
intra- and postoperative transfusion requirements of packed red cells, platelet concentrates and fresh frozen plasma according to defined transfusion thresholds (time frame: begin of surgery and 48h after administration of medication). 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 5 Jan 2012.