Trial Outcomes & Findings for Does An Abnormal PFA 100 Predict Bleeding After Renal Biopsy? (NCT NCT00334204)

NCT ID: NCT00334204

Last Updated: 2013-08-01

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE4
• Target enrollment: 58 participants
• Primary outcome timeframe: 12 hours
• Results posted on: 2013-08-01

Participant Flow

58 parcicipant recruited, 2 excluded due to missing data from analysis

Participant milestones

Measure	Measure PFA-100 measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
Overall Study STARTED	58
Overall Study COMPLETED	56
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Does An Abnormal PFA 100 Predict Bleeding After Renal Biopsy?

Baseline characteristics by cohort

Measure	Measure PFA-100 n=56 Participants measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
Age Continuous	43.68 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 hours

Outcome measures

Measure	Measure PFA-100 n=56 Participants measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
Bleeding After Kidney Biopsy on Renal Ultrasound 12 Hours After Biopsy	11 participants with hematoma

PRIMARY outcome

Timeframe: 12 hours

Outcome measures

Measure	Measure PFA-100 n=56 Participants measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
Hemoglobin/Hematocrit After Biopsy	5 participants with hematuria

PRIMARY outcome

Timeframe: 12

Outcome measures

Measure	Measure PFA-100 n=56 Participants measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
Need for Blood Transfusion	4 participants requiring PRBC Transfusion

Adverse Events

Measure PFA-100

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Tibor Fulop, M.D./Associate Professor of Medicine

University of Mississippi

Phone: 601 984-5670

Email: tfulop@umc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place