PrimingNCT01247051
Comparison of Two Different Heart-lung Machine Filling Methods: Precoating Versus Colloidal Fluids
A study testing Precoating and Standard priming in people with Priming and Cardiac Surgery, run by Johann Wolfgang Goethe University Hospital at 1 site in Germany.
Trial summary
The study is a single-center, randomized, un-blinded treatment study in which patients (>78 years) with the use off a heart-lung machine were provided into two study arms. Patient wit "precoating" have a filling of the machine with their own blood. In the comparator arm, a standard priming is used. Read more about this study
- Who is it for?
- Ages 78 to 95 years
- Conditions the study is for
- Priming, Cardiac Surgery, Cardio Pulmonary Bypass
- What is being tested?
- Precoating and Standard priming
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2011to Aug 2011
- 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 78 to 95 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age > 78 years
- CPB
Who cannot join
- Hb <12 mg/dl
- Off pump surgery
Trial locations and contacts
1 site in 1 country.
About this study
The study is a single-center, randomized, un-blinded treatment study in which patients (>78 years) with the use off a heart-lung machine were provided into two study arms.
Patient wit "precoating" have a filling of the machine with their own blood. In the comparator arm, a standard priming is used.
- Conditions
- Priming, Cardiac Surgery, Cardio Pulmonary Bypass
- Being tested
- Precoating, Standard priming
- Keywords
- priming, cardiac surgery, cardio pulmonary bypass, precoating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrecoatingProcedure or surgery
preoperative filling of heart lung machine with patients blood
Standard primingProcedure or surgery
preoperative filling of heart lung machine with colloids
| Study group | Role | What they receive |
|---|---|---|
| Precoating | Experimental | Not described Receives: Procedure: Precoating |
| Standard priming | Active comparator | Not described Receives: Procedure: Standard priming |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood loss
Measured: 24 hours
Secondary outcomes (1)
Inflammatory response
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrimingStudies 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
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arndt-H. Kiessling, Johann Wolfgang Goethe University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01247051
- Sponsor's protocol ID
- PRE001AHK
- Status last verified
- Aug 2011
- First submitted
- 23 Nov 2010
- Last updated
- 29 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Heart-lung Machine Filling Methods: Precoating Versus Colloidal Fluids
- ClinicalTrials.gov ID
- NCT01247051
- Acronym / sponsor ID
- PRE001AHK
- Conditions
- Priming, Cardiac Surgery, Cardio Pulmonary Bypass
- Keywords
- priming, cardiac surgery, cardio pulmonary bypass, precoating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 24 Nov 2010 (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 is a single-center, randomized, un-blinded treatment study in which patients (>78 years) with the use off a heart-lung machine were provided into two study arms.
Patient wit "precoating" have a filling of the machine with their own blood. In the comparator arm, a standard priming is used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Precoating | Experimental | Procedure: Precoating |
| Standard priming | Active comparator | Procedure: Standard priming |
Who may qualify
- Ages
- 78 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age > 78 years
- CPB
Key exclusion criteria (2 listed)
- Hb <12 mg/dl
- Off pump surgery
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 |
|---|---|---|
| Precoatingpreoperative filling of heart lung machine with patients blood | Procedure or surgery | Precoating |
| Standard primingpreoperative filling of heart lung machine with colloids | Procedure or surgery | Standard priming |
Primary outcome
blood loss
Time frame: 24 hours
1 secondary outcome
Inflammatory response
Time frame: one week
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 29 Aug 2011.
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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 Precoating and Standard priming in people with Priming and Cardiac Surgery, run by Johann Wolfgang Goethe University Hospital 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 2 inclusion and 2 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 29 Aug 2011. 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 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?
blood loss (time frame: 24 hours). 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 29 Aug 2011; AzTrials last refreshed its copy on 1 Nov 2026.