A Phase 2 interventional study of DDAVP in Postoperative Ecchymosis, sponsored by University Hospitals Cleveland Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-08-16.
Sponsored by University Hospitals Cleveland Medical Center · Phase 2, Interventional, and Treatment
This is study looking at the use of a medication, Desmopressin acetate (DDAVP), to reduce bleeding, swelling, and bruising in patients undergoing cosmetic nose surgery. DDAVP is a drug used in patients with bleeding disorders. It works by activating molecules in the blood stream called platelets that promote clotting. In the study, participants who are have cosmetic nose surgery (rhinoplasty) will be randomly assigned to receive or not receive medication. Photographs taken before and shortly after surgery will be evaluated for the amount of bruising and swelling. Patients with heart, lung, kidney, or liver problems are not eligible to participate.
38 studies on the registry are indexed under Ecchymosis; 6 are open to participants now.
This study's enrollment of 14 is below the median of 66 across 34 interventional studies indexed under Ecchymosis.
Browse Ecchymosis studies →University Hospitals Cleveland Medical Center is the lead sponsor of 295 studies on the registry; 45 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 30 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Arm receiving DDAVP prior to the operation. Drug is administered intravenously at .3mcg per kg, over 30 minutes prior to the operation.
Drug: DDAVP
Patients Will not receive DDAVP prior to Rhinoplasty
Patients Receiving DDAVP prior to operation
Also known as: Desmopressin
Reduction in Ecchymosis and Swelling
Photographs taken preoperatively at 1 day and 8 days post-operatively will be analyzed for bruising
Time frame: surgery to 8 days post-operatively
Patient Behavior Factors
Looking at the time it takes for patients to feel comfortable wearing makeup, going out in public, and returning to work
Time frame: Surgery to 3 weeks post-operatively
| Milestone | DDAVP | No DDAVP |
|---|---|---|
| Started | 14 | 0 |
| Completed | 13 | 0 |
| Not completed | 1 | 0 |
| Withdrew: Physician decision | 1 | 0 |
Photographs taken preoperatively at 1 day and 8 days post-operatively will be analyzed for bruising
No measurements were reported for this outcome.
Looking at the time it takes for patients to feel comfortable wearing makeup, going out in public, and returning to work
No measurements were reported for this outcome.
Collected over AE data not collected. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| DDAVP | — | — | — |
| No DDAVP | — | — | — |
No patients were enrolled in the control arm as the study was terminated.
| Age, Categorical(Participants) | DDAVP | No DDAVP | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 14 | 0 | 14 |
| >=65 years | 0 | 0 | 0 |
| Sex: Female, Male(Participants) | DDAVP | No DDAVP | Total |
|---|---|---|---|
| Female | 9 | 0 | 9 |
| Male | 5 | 0 | 5 |
This study is terminated, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Deamino Arginine Vasopressin
University Hospitals Cleveland Medical Center →