HemostasisNCT01008436
Blood Sparing Strategies: Omni-stat Routinary Use in Cardiac Surgery. A Prospective Randomized Study.
A study testing Omni-stat Celox in people with Hemostasis, run by Cardiochirurgia E.H. at 1 site in Italy.
Trial summary
The study enrolles all consecutive patients undergoing cardiac surgery at the European Hospital, Rome. The population undergoes randomization to receive usual surgical hemostasis or added topical application of Omni-stat Celox. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemostasis
- What is being tested?
- Omni-stat Celox
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- Jan 2010to Sep 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients undergoing heart surgery
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
The study enrolles all consecutive patients undergoing cardiac surgery at the European Hospital, Rome. The population undergoes randomization to receive usual surgical hemostasis or added topical application of Omni-stat Celox.
The two populations are followed up prospectively as regarding blood loss and need for blood transfusions, as well as adverse events at 30 days after surgery.
- Conditions
- Hemostasis
- Being tested
- Omni-stat Celox, Control
- Keywords
- Ability of topical drug to reduce acute and overall bleeding as well as blood transfusions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omni-stat CeloxDrug
Topical administration of 6 gr of Omnistat Celox
ControlDrug
Traditional surgical Hemostasis
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Traditional best-practice surgical hemostasis Receives: Drug: Control |
| Omni-stat Celox | Experimental | Administration of 6 gr of Omni-stat Celox intraoperatively at the time of Hemostasis Receives: Drug: Omni-stat Celox |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of blood units transfused to the patients after surgery till discharge
Measured: 30 days
Percentage of acute bleeding controlled by Hemostasis Tool (surgical technique or Omnistat application) in the defined time frame of 10 minutes
Measured: 10 minutes
Secondary outcomes (2)
Blood volume collected in chest drains expressed in milliliters, with partial totals 3, 6 and 12 hours after surgery and final total 24 hours after surgery.
Measured: 3, 6, 12, 24 hours
Time needed to achieve Hemostasis using Omnistat as regarding to defined time frames of 1,2,3,5,7,10 minutes
Measured: 1,2,3,5,7,10 minutes after application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2009 (estimated)
- Study startJan 2010
- Primary completionAug 2010
- Study completionSep 2010
Why it stopped: Lack of product due to industrial changes in the manufacturing process altering the final product.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HemostasisStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardiochirurgia E.H.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luca Weltert, Cardiochirurgia E.H.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01008436
- Sponsor's protocol ID
- 00-03
- Status last verified
- Feb 2012
- First submitted
- 3 Nov 2009
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Sparing Strategies: Omni-stat Routinary Use in Cardiac Surgery. A Prospective Randomized Study.
- ClinicalTrials.gov ID
- NCT01008436
- Acronym / sponsor ID
- 00-03
- Conditions
- Hemostasis
- Keywords
- Ability of topical drug to reduce acute and overall bleeding as well as blood transfusions
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of product due to industrial changes in the manufacturing process altering the final product.
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Cardiochirurgia E.H.University, hospital or other
- Study start
- Jan 2010
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 5 Nov 2009 (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 study enrolles all consecutive patients undergoing cardiac surgery at the European Hospital, Rome. The population undergoes randomization to receive usual surgical hemostasis or added topical application of Omni-stat Celox.
The two populations are followed up prospectively as regarding blood loss and need for blood transfusions, as well as adverse events at 30 days after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: ControlTraditional best-practice surgical hemostasis |
| Omni-stat Celox | Experimental | Drug: Omni-stat CeloxAdministration of 6 gr of Omni-stat Celox intraoperatively at the time of Hemostasis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing heart surgery
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Omni-stat CeloxTopical administration of 6 gr of Omnistat Celox | Drug | Omni-stat Celox |
| ControlTraditional surgical Hemostasis | Drug | Control |
Primary outcome
Number of blood units transfused to the patients after surgery till discharge
Time frame: 30 days
Percentage of acute bleeding controlled by Hemostasis Tool (surgical technique or Omnistat application) in the defined time frame of 10 minutes
Time frame: 10 minutes
2 secondary outcomes
Blood volume collected in chest drains expressed in milliliters, with partial totals 3, 6 and 12 hours after surgery and final total 24 hours after surgery.
Time frame: 3, 6, 12, 24 hours
Time needed to achieve Hemostasis using Omnistat as regarding to defined time frames of 1,2,3,5,7,10 minutes
Time frame: 1,2,3,5,7,10 minutes after application
Results and safety
The study was stopped early (reason given: Lack of product due to industrial changes in the manufacturing process altering the final product.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omni-stat Celox in people with Hemostasis, run by Cardiochirurgia E.H. at 1 site in Italy.
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 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: stopped early, as of the sponsor's last update on 22 Feb 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 Italy. 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: Lack of product due to industrial changes in the manufacturing process altering the final product.). 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?
Number of blood units transfused to the patients after surgery till discharge (time frame: 30 days). The study lists 2 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 22 Feb 2012.