Trial Outcomes & Findings for Study Comparing Desirudin With Heparin to Prevent Vein Clots After Heart and Lung Surgery (NCT NCT00329433)

Results Overview

Blood samples were collected and tested in singlet for the presence of PF4/heparin antibodies. Samples were collected for each participant on PDD (Post-study Drug initiation Day) 2, PDD 7 or at hospital discharge, and at 30 days post surgery.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

120 participants

Primary outcome timeframe

30 days after surgery

Results posted on

2019-03-05

Participant Flow

Participant milestones

Participant milestones
Measure	Desirudin Patients randomized to the desirudin group received desirudin 15mg via subcutaneous administration twice daily (0900 and 2100), with saline placebo given once daily at 1300.	Heparin Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).
Overall Study STARTED	61	59
Overall Study COMPLETED	61	59
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study Comparing Desirudin With Heparin to Prevent Vein Clots After Heart and Lung Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Desirudin n=61 Participants Patients randomized to the desirudin group received desirudin 15mg via subcutaneous administration twice daily (0900 and 2100), with saline placebo given once daily at 1300.	Heparin n=59 Participants Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).	Total n=120 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=5 Participants	39 Participants n=7 Participants	77 Participants n=5 Participants
Age, Categorical >=65 years	23 Participants n=5 Participants	20 Participants n=7 Participants	43 Participants n=5 Participants
Age, Continuous	62 years STANDARD_DEVIATION 11 • n=5 Participants	61 years STANDARD_DEVIATION 12 • n=7 Participants	61 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants	22 Participants n=7 Participants	48 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants	37 Participants n=7 Participants	72 Participants n=5 Participants
Region of Enrollment United States	61 participants n=5 Participants	59 participants n=7 Participants	120 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days after surgery

Population: Intent-to-treat analysis was performed according to initial group assignment.

Blood samples were collected and tested in singlet for the presence of PF4/heparin antibodies. Samples were collected for each participant on PDD (Post-study Drug initiation Day) 2, PDD 7 or at hospital discharge, and at 30 days post surgery.

Outcome measures

Outcome measures
Measure	Desirudin n=61 Participants Patients randomized to the desirudin group received desirudin 15mg via subcutaneous administration twice daily (0900 and 2100), with saline placebo given once daily at 1300.	Heparin n=59 Participants Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).
The Primary Outcome Measure Was the Number of Participants With New Heparin Platelet Factor 4 (HIT Positive) Antibodies in Each Group Within 30 Days Following Surgery.	6 participants	8 participants

SECONDARY outcome

Timeframe: 7 days after surgery

Population: 61 in Desirudin group and 59 in heparin group.

Outcome measures

Outcome measures
Measure	Desirudin n=61 Participants Patients randomized to the desirudin group received desirudin 15mg via subcutaneous administration twice daily (0900 and 2100), with saline placebo given once daily at 1300.	Heparin n=59 Participants Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).
The Incidence of DVTs in Each Group.	3 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to 30 days after surgery

Population: Intention to treat.

Outcome measures

Outcome measures
Measure	Desirudin n=61 Participants Patients randomized to the desirudin group received desirudin 15mg via subcutaneous administration twice daily (0900 and 2100), with saline placebo given once daily at 1300.	Heparin n=59 Participants Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).
The Incidence of Bleeding in Each Group.	2 Participants	2 Participants

Adverse Events

Desirudin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Heparin

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

Michael S. Avidan, MBBCh

Washington University School of Medicine

Phone: 314-747-4155

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60