Trial Outcomes & Findings for Safety Study of Quickclot for Bleeding Control After Adenotonsillectomy (NCT NCT01863563)
NCT ID: NCT01863563
Last Updated: 2019-03-26
Results Overview
After removal of the adenoids, a tonsil pack wrapped in QuikClot will be placed in the nasopharynx. The investigators will then perform tonsillectomy with the Microdebrider. A QuikClot roll will be placed in the tonsil fossa, and pressure applied via tonsil sponge for one minute. The contralateral tonsil will then be addressed with the same technique. The QuikClot adenoid pack is then removed and residual adenoidal bleeding is addressed with suction electrocautery, followed by placement of a second QuikClot adenoid pack. The tonsil rolls are sequentially removed, followed by control of residual hemostasis with suction electrocautery. A second set of tonsil rolls are placed. After adenoid pack is removed from nasopharynx and bleeding controlled, tonsil rolls are removed, followed by suction electrocautery for any residual hemostasis is performed.
COMPLETED
NA
100 participants
at the time of surgery, 1 hour
2019-03-26
Participant Flow
Tertiary children's hospital enrolled 100 consectutive children
Participant milestones
| Measure |
QuickClot
single dose
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
100
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety Study of Quickclot for Bleeding Control After Adenotonsillectomy
Baseline characteristics by cohort
| Measure |
Quickclot
n=100 Participants
QuickClot sponge will be applied for one minute each site of tonsillectomy and Adenoidectomy
|
|---|---|
|
Age, Categorical
<=18 years
|
100 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
4.8 years
STANDARD_DEVIATION 3.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at the time of surgery, 1 hourAfter removal of the adenoids, a tonsil pack wrapped in QuikClot will be placed in the nasopharynx. The investigators will then perform tonsillectomy with the Microdebrider. A QuikClot roll will be placed in the tonsil fossa, and pressure applied via tonsil sponge for one minute. The contralateral tonsil will then be addressed with the same technique. The QuikClot adenoid pack is then removed and residual adenoidal bleeding is addressed with suction electrocautery, followed by placement of a second QuikClot adenoid pack. The tonsil rolls are sequentially removed, followed by control of residual hemostasis with suction electrocautery. A second set of tonsil rolls are placed. After adenoid pack is removed from nasopharynx and bleeding controlled, tonsil rolls are removed, followed by suction electrocautery for any residual hemostasis is performed.
Outcome measures
| Measure |
Cauterization Time
n=100 Participants
single dose
|
|---|---|
|
Total Suction Electrocautery Time Required for Hemostasis Will be Recorded as Seconds
tonsil cauterization time
|
94.5 seconds
Standard Deviation 41.9
|
|
Total Suction Electrocautery Time Required for Hemostasis Will be Recorded as Seconds
total cauterization time
|
155.3 seconds
Standard Deviation 59.7
|
|
Total Suction Electrocautery Time Required for Hemostasis Will be Recorded as Seconds
adenoid cauterization time
|
60.9 seconds
Standard Deviation 31.5
|
Adverse Events
Adverse Events
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Craig Derkay, MD
Children's Hospital of the Kings Daughters
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place