ClinicalTrials.gg
TerminatedNCT01547728Updated Jul 15, 2015Results posted

Response of Recombinant Antithrombin in Heparin Resistant Patients Undergoing Cardiac Surgery

A Phase 4 interventional study of Recombinant antithrombin (rhAT) in Thrombophilia Due to Acquired Antithrombin III Deficiency, sponsored by Mayo Clinic. Terminated at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2015-07-15.

Sponsored by Mayo Clinic · Phase 4, Interventional, and Treatment

Why this study was terminated
Too many barriers to enroll participants.
Phase
Phase 4
Study type
Interventional
Enrollment
42
Allocation
Not applicable
Ages
18 Years to 90 Years
Sex
All
01

Study summary

The objective of this study is to prospectively evaluate the response of recombinant antithrombin (rAT) (ATRYN) in patients who are heparin resistant and are scheduled to undergo cardiac surgery.

Read the detailed description

AT is an α2-globulin that is produced primarily in the liver. It binds thrombin, as well as other serine proteases, factors IX, X, XI, and XII, kallikrein, and plasmin irreversibly, which neutralizes their activity. However, only inhibition of thrombin and factor Xa by AT has physiologic and clinical significance.1 AT deficiency may occur as a congenital or acquired deficiency. Acquired deficiencies are secondary to increased AT consumption, loss of AT from the intravascular compartment (renal failure, nephrotic syndrome) or liver disease (cirrhosis). A normal AT level is 80% to 120% with activity below 50% considered clinically important based on the risk of venous thrombosis in patients with congenital deficiency of AT.2 However, the risk of thrombosis is higher in congenital forms than acquired forms of AT deficiency.3, 4 Unfortunately, the only abnormal coagulation test associated with this condition is the assay for AT activity, which is diagnostic but not readily available.

Acquired deficiencies of AT are commonly encountered in cardiac surgical patients. Anticoagulation with heparin for CPB depends on AT to inhibit clotting as heparin alone has no effect on coagulation. Heparin catalyzes AT inhibition of thrombin over a 1000 fold by binding to a lysine residue on AT and altering its conformation. Thrombin actually attacks AT, disabling it, but in the process attaches AT to thrombin, forming a complex that can be detected and used to assess thrombin formation but has no activity. Thirty percent of AT is consumed during this process so AT levels are reduced temporarily. If AT levels are not restored, then a condition may arise called heparin resistance. There are other less frequent causes of heparin resistance besides AT deficiency such as platelets, fibrin, vascular surfaces and plasma proteins.5 There is no universally accepted definition of heparin resistance. It is broadly defined as the failure of a specific heparin dose (300 - 400 u/kg) to prolong an ACT beyond 400 - 480 seconds in preparation for initiation of CPB. Because the definition of heparin resistance may differ according to both heparin dose and target ACT, the incidence of heparin resistance in the literature is very variable. A recent randomized prospective study analyzing 2270 cardiac cases, identified 3.7% of the patients to be heparin resistant but the incidence has been reported as high as 18% - 30% The incidence of heparin resistance is likely to further increase as the use of heparin infusions prior to cardiac surgery becomes more prevalent.

02

Conditions studied

  • Thrombophilia Due to Acquired Antithrombin III Deficiency

Keywords

  • antithrombin
  • Heparin Resistant
  • Cardiac Surgery
03

In context

Lead sponsor

Mayo Clinic is the lead sponsor of 3,264 studies on the registry; 670 are open to participants now.

Of its 450 completed or terminated interventional studies of FDA-regulated products, 318 (71%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients undergoing cardiac surgery requiring cardiopulmonary bypass (CPB)
  • Heparin resistant according to this definition: initial activated clotting time (ACT) after an intravenous loading dose of heparin (300 u/kg) is less than 480 seconds

Exclusion criteria

Exclusion criteria:

  • current use of one or more of these medications:

    • warfarin (within 3 days of surgery);
    • streptokinase;
    • tissue plasminogen activator;
    • abciximab,
    • eptifibatide,
    • tirofiban or
    • clopidogrel.
  • known hypersensitivity to goat or goat milk proteins,
  • patients with pre-existing coagulopathy defined as a history of bleeding or laboratory bleeding disorder (e.g., von Willebrand disease, platelet disorder) and
  • patients receiving direct thrombin inhibitors
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    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.

    Drug: Recombinant antithrombin (rhAT)

Interventions

  • 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.

    Also known as: ATryn®

06

What researchers measure

Primary outcomes

  1. Percentage of Patients Whose Activated Clotting Time (ACT) is Prolonged Beyond 480 Seconds With Recombinant Human Antithrombin Concentrate (rhAT) Administration

    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.

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

07

Results

Posted Jul 15, 2015
Limitations and caveats
The study was terminated because there were too many barriers to enroll participants.

Participant flow

Subjects were recruited from Mayo Clinic in Rochester, Minnesota.

Participant flow — Overall Study
MilestoneRecombinant Antithrombin (rhAT)
Started42
Completed1
Not completed41
Withdrew: Change in procedure and equipment1
Withdrew: Drug not ready for subject1
Withdrew: Screen failure39

Outcome measures

PrimaryPercentage of Patients Whose Activated Clotting Time (ACT) is Prolonged Beyond 480 Seconds With Recombinant Human Antithrombin Concentrate (rhAT) Administration

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.

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

No measurements were reported for this outcome.

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Recombinant Antithrombin (rhAT)—0/1 (0%)0/1 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Recombinant Antithrombin (rhAT)
Mean64 (19 to 83)
Sex: Female, Male
Sex: Female, Male(Participants)Recombinant Antithrombin (rhAT)
Female15
Male27
Region of Enrollment
Region of Enrollment(participants)Recombinant Antithrombin (rhAT)
United States42
08

Study locations

1 site
  • Mayo Clinic in Rochester
    Rochester, Minnesota 55905, United States
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2012, a primary completion of Feb 2014 and a completion of Feb 2014. It does not say whether these dates are actual or estimated.

Results were first posted in Jul 2015, 1 year 5 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 7, 2012
First posted
Mar 8, 2012
Start
Feb 2012
Primary completionActual
Feb 2014
CompletionActual
Feb 2014
Results first posted
Jul 15, 2015
Last update
Jul 15, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01547728
Lead sponsor
Mayo Clinic
Collaborators
rEVO Biologics
Responsible party
William C. Oliver (Consulatant Cardio/Thoracic Anesthesia, Mayo Clinic) — Principal investigator
First posted
Mar 8, 2012
Start date
Feb 2012
Primary completion
Feb 2014
Completion
Feb 2014
Results posted
Jul 15, 2015
Last update
Jul 15, 2015

Study contacts

William Oliver, MD
principal investigator · Mayo Clinic

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Antithrombin alfa

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