N/A
N=100
Safety Study of Quickclot for Bleeding Control After Adenotonsillectomy
Sleep Apnea, Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT01863563 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Mar 2018
Primary outcome: Primary: Total Suction Electrocautery Time Required for Hemostasis Will be Recorded as Seconds — 155.3; 60.9; 94.5 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- QuickClot (Device)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- Eastern Virginia Medical School
- Primary completion
- Nov 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Total Suction Electrocautery Time Required for Hemostasis Will be Recorded as Seconds |
155.3; 60.9; 94.5 | — |
Summary
Hemostasis will be achieved during Pediatric Tonsillectomy/Adenoidectomy with the use of QuickClot.
Eligibility Criteria
Inclusion Criteria
- diagnosis of adenotonsillar hypertrophy causing obstructive sleep disorders
Exclusion Criteria
- Patients with signs or symptoms of obstructed breathing
- recurrent pharyngitis
- history of bleeding disorder
- history of prior adenotonsillectomy
Data sourced from ClinicalTrials.gov (NCT01863563). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.