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

Eligibility Criteria

Sex

ALL

Age

18 Years - 85 Years

Healthy Volunteers

Not accepted

Interventions

• Human plasma derived antithrombin — DRUG
  A solvent/detergent and heat-treated antithrombin concentrate derived from human plasma
• Placebo — DRUG
  Half of the patients in the placebo group will be randomised to receive a volume of placebo corresponding to the low dose of Atenativ and the other half to receive a volume of placebo corresponding to a high dose of Atenativ

Study Details

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)

Key Dates

Start date

Aug 21, 2024

Status verified

Jan 2026

Primary completion

Mar 31, 2028

Completion

Mar 31, 2028

Study Design

Enrollment

120 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Low-dose Atenativ
  Patients will receive a single bolus of 30 international units (IU)/kg body weight (BW) Atenativ.
• Experimental: High-dose Atenativ
  Patients will receive a single bolus of 60 international units (IU)/kg body weight (BW) Atenativ.
• Placebo Comparator: Placebo
  Patients will receive a saline bolus dose

Primary Outcome Measure

Restoring heparin responsiveness [ Time Frame: During surgery (from the time of the first surgical incision to the time at which the final suture or staple is placed) ]

Central Contacts

• Cristina Solomon, MD
  +41 79 585 90 42
  [email protected]

Locations (9)

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