Trial Outcomes & Findings for Study of the Effect of Differing Platelet Transfusion Times in Neonates (NCT NCT00948792)

Results Overview

The difference between the baseline platelet count and the platelet count taken 30 minutes after completion of the transfusion.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

Baseline-30 minutes after transfusion

Results posted on

2011-07-12

Participant Flow

Participant milestones

Participant milestones
Measure	Short and Long Transfusion Group This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes (short) or 2 hours (long).
Overall Study STARTED	21
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of the Effect of Differing Platelet Transfusion Times in Neonates

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Short and Long Transfusion Group n=21 Participants This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes (short) or two hours (long).
Age, Categorical <=18 years	21 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	26 Days FULL_RANGE .09 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	21 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline-30 minutes after transfusion

Population: Transfusions were randomized, not babies. Therefore, each baby could provide transfusions falling into either arm of randomization. The 21 long transfusions were provided by 14 infants; the 22 short transfusions by 15. This explains the perceived discrepancy.

The difference between the baseline platelet count and the platelet count taken 30 minutes after completion of the transfusion.

Outcome measures

Outcome measures
Measure	Long Transfusion Group n=21 transfusions This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of two hours.	Short Transfusion Group n=22 transfusions This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes.
Change in Post-transfusion Platelet Counts	99 Platelets (*10^3/mm^3) Interval -19.0 to 442.0	97.5 Platelets (*10^3/mm^3) Interval 19.0 to 260.0

PRIMARY outcome

Timeframe: Baseline - 6 hours after transfusion

Population: Transfusions were randomized, not babies. Therefore, each baby could provide transfusions falling into either arm of randomization. The 21 long transfusions were provided by 14 infants; the 22 short transfusions by 15. This explains the perceived discrepancy.

The difference between the baseline platelet count and the platelet count taken 6 hours after completion of the transfusion.

Outcome measures

Outcome measures
Measure	Long Transfusion Group n=21 Transfusions This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of two hours.	Short Transfusion Group n=22 Transfusions This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes.
Change in Post-transfusion Platelet Counts	75 Platelets (*10^3/mm^3) Interval -17.0 to 316.0	104 Platelets (*10^3/mm^3) Interval 4.0 to 294.0

PRIMARY outcome

Timeframe: 30 minutes - 6 hours after transfusion

Population: Transfusions were randomized, not babies. Therefore, each baby could provide transfusions falling into either arm of randomization. The 21 long transfusions were provided by 14 infants; the 22 short transfusions by 15. This explains the perceived discrepancy.

Outcome measures

Outcome measures
Measure	Long Transfusion Group n=21 Transfusions This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of two hours.	Short Transfusion Group n=22 Transfusions This group of thrombocytopenic neonates who (as determined by the attending physician) are in need of a platelet transfusion will receive the transfusion over a period of 30 minutes.
30 Minute-6 Hour Difference in Platelet Counts	-17.5 Platelets (*10^3/mm^3) Interval -110.0 to 29.0	-3 Platelets (*10^3/mm^3) Interval -84.0 to 81.0

Adverse Events

Long Transfusion Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Short Transfusion Group

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

Doug Dannaway

University of Oklahoma Health Sciences Center

Phone: 4052715215

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place