Open Fracture of FootNCT01848431
Randomized Study on the Effects of Moderate Anaemia in Free Microvascular Tissue Transfer
An observational study of Open Fracture of Foot and Tumor, run by University of Zurich at 1 site in Switzerland.
Trial summary
The evaluation of Perfusion of free flaps in patients with moderate anaemia and possible reduction of the transfusion threshold. Trial with surgical intervention Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Fracture of Foot, Tumor
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2013to Jan 2018
- Phase
- Observational
- 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
Study population: patients scheduled for defect reconstruction with free flaps and a preoperative hematocrit of 28 % or below
Who may be able to join
- planned defect reconstruction with free flap and preoperative hematocrit of 28% or below
Who cannot join
- coagulation disorder
- Jehovah's witness
- iodine allergy
- renal or hepatic insufficiency
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Center for Reconstructive Surgery
Zurich, Canton of Zurich, 8091
About this study
The evaluation of Perfusion of free flaps in patients with moderate anaemia and possible reduction of the transfusion threshold.
- Trial with surgical intervention
Read the detailed description
In study group 1 patients will be kept at a hematocrit level below 28% and only receive transfusions if symptomatic or the fall below 25%. Patients in group 2 will receive transfusions to reach a hematocrit always above 30%.
Tissue perfusion in free flaps will be measured with indocyanine green fluorescence angiography, confocal microscopy and oxygen partial pressure measurement probes.
- Conditions
- Open Fracture of Foot, Tumor
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| anaemia group | no blood transfusions will be given until hct falls under 25% | |
| normal hct group | patients in group 2 will receive transfusions as is currently standard protocol outside the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Blood transfusions peri- and postoperative
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2013 (estimated)
- Study startMay 2013 (estimated)
- Primary completionJan 2018
- Study completionJan 2018
Why it stopped: staff change and lack of ressources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Fracture of FootStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maurizio Calcagni, MD, Principal investigator, University Hospital Zurich, Clinic of Reconstructive Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01848431
- Sponsor's protocol ID
- FF-HTC Verson 1-3
- Status last verified
- Dec 2014
- First submitted
- 22 Apr 2013
- Last updated
- 10 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study on the Effects of Moderate Anaemia in Free Microvascular Tissue Transfer
- ClinicalTrials.gov ID
- NCT01848431
- Acronym / sponsor ID
- FF-HTC Verson 1-3
- Conditions
- Open Fracture of Foot, Tumor
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: staff change and lack of ressources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- May 2013 (estimated)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 7 May 2013 (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 evaluation of Perfusion of free flaps in patients with moderate anaemia and possible reduction of the transfusion threshold.
- Trial with surgical intervention
Detailed description
In study group 1 patients will be kept at a hematocrit level below 28% and only receive transfusions if symptomatic or the fall below 25%. Patients in group 2 will receive transfusions to reach a hematocrit always above 30%.
Tissue perfusion in free flaps will be measured with indocyanine green fluorescence angiography, confocal microscopy and oxygen partial pressure measurement probes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anaemia group | – | –no blood transfusions will be given until hct falls under 25% |
| normal hct group | – | –patients in group 2 will receive transfusions as is currently standard protocol outside the study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients scheduled for defect reconstruction with free flaps and a preoperative hematocrit of 28 % or below
Key inclusion criteria (1 listed)
- planned defect reconstruction with free flap and preoperative hematocrit of 28% or below
Key exclusion criteria (4 listed)
- coagulation disorder
- Jehovah's witness
- iodine allergy
- renal or hepatic insufficiency
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of Blood transfusions peri- and postoperative
Time frame: 10 days
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 10 Nov 2020.
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.
Maurizio Calcagni, MD principal investigator
University Hospital Zurich, Clinic of Reconstructive Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Open Fracture of Foot and Tumor, run by University of Zurich at 1 site in Switzerland.
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 4 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 10 Nov 2020. 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 Switzerland. 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 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?
Number of Blood transfusions peri- and postoperative (time frame: 10 days). 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 10 Nov 2020.