RECRUITING

Phase 3 Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Patients Scheduled to Undergo Cardiac Surgery Necessitating Cardiopulmonary Bypass

Conditions

Acquired Antithrombin Deficiency heparin resistance antithrombin deficiency cardiopulmonary bypass cardiac surgery

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The primary objective of this study is to evaluate the efficacy of two different doses of Atenativ, versus placebo, in restoring and maintaining heparin responsiveness in adult patients undergoing cardiac surgery necessitating cardiopulmonary bypass (CPB)

Official Title

Phase 3, Double-blind, Placebo-controlled, Multicentre Study on the Efficacy and Safety of Human Plasma Derived Antithrombin (Atenativ) in Heparin-Resistant Patients Scheduled to Undergo Cardiac Surgery Necessitating Cardiopulmonary Bypass

Quick Facts

Study Start:2024-12

Study Completion:2026-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06096116

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Planned cardiac surgery with CPB 2. Heparin-resistant patients (pre-CPB Hemochron ACT less than 480 s in the measurement taken between 2-5 minutes following intravenous administration of 500 U/kg UFH) 3. Patients between 18 and 85 years of age, inclusive 4. Freely given written or electronic informed consent 5. In female patients of childbearing potential, a pre-existing negative pregnancy test within 14 days prior to surgery	1. Receiving, or have received within the timeframes specified, one or more of the following medications prior to the start of surgery: 1. warfarin (within 3 days) 2. direct oral anticoagulants (within 2 days) 3. ticlopidine (within 14 days) 4. prasugrel (within 7 days) 5. clopidogrel (within 5 days) 6. ticagrelor (within 5 days) 7. glycoprotein IIb/IIIa antagonist (within 1 day) 2. Pre-existing coagulopathy, a history of bleeding problems, a history of bleeding problems, or a laboratory-diagnosed bleeding disorder (e.g., von Willebrand disease, platelet disorder) 3. Renal insufficiency, defined as serum creatinine level \>1.5 mg/dL 4. Known hypersensitivity or allergic reaction to antithrombin or any of the excipients in Atenativ i.e., human albumin, sodium chloride, acetyl tryptophan, caprylic acid 5. History of anaphylactic reaction(s) to blood or blood components 6. Refusal to receive transfusion of blood or blood-derived products 7. Current participation in another interventional clinical trial or previous participation in the current trial 8. Treatment with any IMP within 30 days prior to screening visit

Inclusion Criteria

Exclusion Criteria

1. Planned cardiac surgery with CPB
2. Heparin-resistant patients (pre-CPB Hemochron ACT less than 480 s in the measurement taken between 2-5 minutes following intravenous administration of 500 U/kg UFH)
3. Patients between 18 and 85 years of age, inclusive
4. Freely given written or electronic informed consent
5. In female patients of childbearing potential, a pre-existing negative pregnancy test within 14 days prior to surgery

1. Receiving, or have received within the timeframes specified, one or more of the following medications prior to the start of surgery:
1. warfarin (within 3 days)
2. direct oral anticoagulants (within 2 days)
3. ticlopidine (within 14 days)
4. prasugrel (within 7 days)
5. clopidogrel (within 5 days)
6. ticagrelor (within 5 days)
7. glycoprotein IIb/IIIa antagonist (within 1 day)
2. Pre-existing coagulopathy, a history of bleeding problems, a history of bleeding problems, or a laboratory-diagnosed bleeding disorder (e.g., von Willebrand disease, platelet disorder)
3. Renal insufficiency, defined as serum creatinine level \>1.5 mg/dL
4. Known hypersensitivity or allergic reaction to antithrombin or any of the excipients in Atenativ i.e., human albumin, sodium chloride, acetyl tryptophan, caprylic acid
5. History of anaphylactic reaction(s) to blood or blood components
6. Refusal to receive transfusion of blood or blood-derived products
7. Current participation in another interventional clinical trial or previous participation in the current trial
8. Treatment with any IMP within 30 days prior to screening visit

Contacts and Locations

Study Contact

Sigurd Knaub, PhD

CONTACT

+41554512141

Sigurd.Knaub@octapharma.com

Study Locations (Sites)

Duke University Medical Center

Durham, North Carolina, 27710-1000

United States

Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157

United States

OU Health University of Oklahoma Medical Center

Oklahoma City, Oklahoma, 73104

United States

Collaborators and Investigators

Sponsor: Octapharma

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12

Study Completion Date2026-09

Study Record Updates

Study Start Date2024-12

Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

heparin resistance
antithrombin deficiency
cardiopulmonary bypass
cardiac surgery

Additional Relevant MeSH Terms

Acquired Antithrombin Deficiency