Trial Outcomes & Findings for Study Comparing Bivalirudin Versus Heparin in Neonatal and Pediatric ECMO (NCT NCT03318393)

NCT ID: NCT03318393

Last Updated: 2023-01-31

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 30 participants
• Primary outcome timeframe: through study completion, an average of 1-2 weeks
• Results posted on: 2023-01-31

Participant Flow

Participant milestones

Measure	Unfractionated Heparin Group Patients randomized to this arm will undergo usual care using unfractionated heparin as the primary anticoagulant. Unfractionated heparin: Continuous infusion	Bivalirudin Group Patients randomized to this arm will receive anticoagulation with bivalirudin Bivalirudin: Continuous infusion
Overall Study STARTED	14	16
Overall Study COMPLETED	14	16
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Unfractionated Heparin Group n=14 Participants Patients randomized to this arm will undergo usual care using unfractionated heparin as the primary anticoagulant. Unfractionated heparin: Continuous infusion	Bivalirudin Group n=16 Participants Patients randomized to this arm will receive anticoagulation with bivalirudin Bivalirudin: Continuous infusion	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	14 Participants n=14 Participants	16 Participants n=16 Participants	30 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=14 Participants	0 Participants n=16 Participants	0 Participants n=30 Participants
Age, Categorical >=65 years	0 Participants n=14 Participants	0 Participants n=16 Participants	0 Participants n=30 Participants
Sex: Female, Male Female	7 Participants n=14 Participants	11 Participants n=16 Participants	18 Participants n=30 Participants
Sex: Female, Male Male	7 Participants n=14 Participants	5 Participants n=16 Participants	12 Participants n=30 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	14 participants n=14 Participants	16 participants n=16 Participants	30 participants n=30 Participants

PRIMARY outcome

Timeframe: through study completion, an average of 1-2 weeks

Outcome measures

Measure	Unfractionated Heparin Group n=14 Participants Patients randomized to this arm will undergo usual care using unfractionated heparin as the primary anticoagulant. Unfractionated heparin: Continuous infusion	Bivalirudin Group n=16 Participants Patients randomized to this arm will receive anticoagulation with bivalirudin Bivalirudin: Continuous infusion
Percentage of Time Spent at Goal Anticoagulation	0.63 percentage of time Interval 0.5 to 0.82	0.49 percentage of time Interval 0.31 to 0.54

SECONDARY outcome

Timeframe: through study completion, an average of 1-2 weeks

Bleeding events will include drop in hemoglobin, surgical site bleeding, intracranial hemorrhage, fatal bleeding, extra surgical or unexpected surgical site bleeding

Outcome measures

Measure	Unfractionated Heparin Group n=14 Participants Patients randomized to this arm will undergo usual care using unfractionated heparin as the primary anticoagulant. Unfractionated heparin: Continuous infusion	Bivalirudin Group n=16 Participants Patients randomized to this arm will receive anticoagulation with bivalirudin Bivalirudin: Continuous infusion
Number of Participants With One or More Major Bleeding Events	7 participants	7 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: through study completion, an average of 1-2 weeks

Will include fresh frozen plasma (FFP), packed red blood cells (pRBCs), platelets and cryoprecipitate

Outcome measures

Measure	Unfractionated Heparin Group n=14 Participants Patients randomized to this arm will undergo usual care using unfractionated heparin as the primary anticoagulant. Unfractionated heparin: Continuous infusion	Bivalirudin Group n=16 Participants Patients randomized to this arm will receive anticoagulation with bivalirudin Bivalirudin: Continuous infusion
Number of Blood Products Transfused FFP	0.16 mls/kg/day Interval 0.0 to 2.84	1.15 mls/kg/day Interval 0.24 to 2.79
Number of Blood Products Transfused pRBCs	12.2 mls/kg/day Interval 5.52 to 14.46	6.29 mls/kg/day Interval 2.49 to 8.41
Number of Blood Products Transfused Platelets	13.58 mls/kg/day Interval 2.43 to 23.94	4.55 mls/kg/day Interval 0.55 to 11.51
Number of Blood Products Transfused Cryoprecipitate	0 mls/kg/day Interval 0.0 to 0.19	0.1 mls/kg/day Interval 0.0 to 1.14

Adverse Events

Unfractionated Heparin Group

Serious events: 7 serious events

Other events: 0 other events

Deaths: 2 deaths

Bivalirudin Group

Serious events: 7 serious events

Other events: 0 other events

Deaths: 3 deaths

Serious adverse events

Measure	Unfractionated Heparin Group n=14 participants at risk Patients randomized to this arm will undergo usual care using unfractionated heparin as the primary anticoagulant. Unfractionated heparin: Continuous infusion	Bivalirudin Group n=16 participants at risk Patients randomized to this arm will receive anticoagulation with bivalirudin Bivalirudin: Continuous infusion
Blood and lymphatic system disorders Major bleeding event	50.0% 7/14 • From Baseline, daily until the end of study, an average of up to 0.1 year	43.8% 7/16 • From Baseline, daily until the end of study, an average of up to 0.1 year

Other adverse events

Adverse event data not reported

Additional Information

Lakshmi Raman

UT Southwestern Medical Center

Phone: 214-456-6222

Email: lakshmi.raman@utsw.edu

Results disclosure agreements

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