Trial Outcomes & Findings for Response of Recombinant Antithrombin in Heparin Resistant Patients Undergoing Cardiac Surgery (NCT NCT01547728)

Results Overview

Restored antithrombin level is defined as an activated clotting time \> 480 seconds 3 minutes after the initial dose of 500 units of rhAT is administered. The percentage of patients who meet this criterion will be summarized using a point estimate and a 95% confidence interval.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

42 participants

Primary outcome timeframe

3 minutes after the initial dose of rhAT, Day 1 of the study

Results posted on

2015-07-15

Participant Flow

Subjects were recruited from Mayo Clinic in Rochester, Minnesota.

Participant milestones

Participant milestones
Measure	Recombinant Antithrombin (rhAT) Subjects will receive an intravenous bolus of 500 units of recombinant, human antithrombin (rhAT, ATRYN ®). If the subject remains heparin-resistant, one more IV bolus of 500 units rhAT is given.
Overall Study STARTED	42
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	41

Reasons for withdrawal

Reasons for withdrawal
Measure	Recombinant Antithrombin (rhAT) Subjects will receive an intravenous bolus of 500 units of recombinant, human antithrombin (rhAT, ATRYN ®). If the subject remains heparin-resistant, one more IV bolus of 500 units rhAT is given.
Overall Study Change in procedure and equipment	1
Overall Study Drug not ready for subject	1
Overall Study Screen failure	39

Baseline Characteristics

Response of Recombinant Antithrombin in Heparin Resistant Patients Undergoing Cardiac Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Recombinant Antithrombin (rhAT) n=42 Participants Subjects will receive an intravenous bolus of 500 units of recombinant, human antithrombin (rhAT, ATRYN ®). If the subject remains heparin-resistant, one more IV bolus of 500 units rhAT is given.
Age, Continuous	64 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Region of Enrollment United States	42 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 minutes after the initial dose of rhAT, Day 1 of the study

Population: The study was terminated because there were too many barriers to enroll participants.

Restored antithrombin level is defined as an activated clotting time \> 480 seconds 3 minutes after the initial dose of 500 units of rhAT is administered. The percentage of patients who meet this criterion will be summarized using a point estimate and a 95% confidence interval.

Outcome measures

Outcome data not reported

Adverse Events

Recombinant Antithrombin (rhAT)

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

Dr. William Oliver

Mayo Clinic Rochester

Phone: 507-255-4240

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60