Early Discovery of Ischemia After Replantation Surgery of the Extremities (NCT05297266) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Early Discovery of Ischemia After Replantation Surgery of the Extremities
Norway60 participantsStarted 2022-11-15
Plain-language summary
Investigators will test if changes in CO2 is detected postoperatively in ischemic tissue in a replanted extremity of a traumatically amputated upper or lower extremity. IscAlert is measuring continuously CO2 in muscular and subcutaneous tissue. IscAlert is inserted distal to the operative field into normal muscle and/or subcutaneous tissue in the replanted extremity. Local tissue CO2 and temperature will be monitored continuously postoperatively for the next 10 days. If a reduced or totally obstructed blood flow appear (thrombosis), an increase in tissue CO2 and a lower local temperature will emerge rapidly as a sign of ischemia. This will be detected by the sensor which will alarm the investigators. This will lead to assessment of the replanted extremity and if restricted blood flow is diagnosed, a reoperation will be performed. After reoperation new sensors will be implanted for another ten days if applicable. Sixty patients will be enrolled to undergo the procedures. The IscAlert will be removed from the patient before the patient is discharged from the hospital or a maximum of 10 days (the event that occurs first). 500 devices is planned to be used in this clinical study.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must be in need of extremity replantation surgery
* Subject must be ≥ 18 years
* Able to give written signed informed consent
Exclusion Criteria:
* None
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is measuring tissue CO2 levels to detect ischemia early after replantation surgery — can you explain how monitoring carbon dioxide in the tissue helps catch blood circulation problems sooner than current methods, and whether that could change how my care would be managed?
2Since this study is listed as 'active but no longer recruiting,' does that mean there's any chance I could still be considered for participation, or are there similar monitoring approaches already being used in my treatment?
3The trial focuses specifically on traumatic amputation and replantation surgery — given my situation, is this type of CO2 biosensing monitoring something my surgical team already has access to, or is it only available through research settings?
4Because this is listed as a Phase NA study, what does that tell us about how much is already known about the safety and reliability of this CO2 monitoring technique, and should that affect my expectations about what it can and can't detect?
5Are there standard post-replantation monitoring approaches already in routine use that you'd recommend for me, and how do they compare to what this trial is investigating in terms of catching ischemia early?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.