Aprotinin

Overview

Aprotinin is a protein-based drug that is also known as bovine pancreatic trypsin inhibitor (BPTI). Since it demonstrates the capacity to slow fibrinolysis, it has been employed to reduce bleeding during complex surgery such as heart and liver surgery. For this use, it is typically administered by injection. The goal of using of aprotinin was subsequently to minimize end-organ damage resulting from hypotension due to blood loss in surgery and to reduce the necessity for blood transfusions during surgery. Nevertheless, the drug was formally withdrawn worldwide in May of 2008 after studies confirmed that its use enhanced the risk of complications or death. The substance is consequently made available only for very restricted research use.

Indication

For prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery who are at an increased risk for blood loss and blood transfusion.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
An Open Non-comparative Study of the Efficacy and Safety of Aprotinin in Patients Hospitalized With COVID-19	2020/08/26	NCT04527133	Not Applicable	UNKNOWN	Aviron LLC
Effect of Aprotinin on Transfusion Requirements and Blood Loss in Patients Undergoing Elective Primary Total Hip Replacement	2008/04/28	NCT00668031	Phase 3	Completed	Bayer
Effects of Aprotinin During Cardiac Surgery/Long Term Death Rates	2008/02/18	NCT00617955	N/A	Completed	State University of New York - Upstate Medical University
Aprotinin US Special Access Protocol	2008/02/11	NCT00611845	N/A	NO_LONGER_AVAILABLE	Bayer
Comparison of Aprotinin and Tranexamic Acid in Routine Cardiac Surgery	2006/11/07	NCT00396760	Phase 3	UNKNOWN	German Heart Center
Effect of Intraoperative Aprotinin Administration on Post Cardiac Surgery Optic Nerve and Retinal Thickness.	2006/11/02	NCT00395369	Not Applicable	UNKNOWN	Soroka University Medical Center
Can Aprotinin Reduce Pancreatitis After Scoliosis Surgery	2006/07/28	NCT00357851	Phase 1	Completed	Nemours Children's Clinic
Phase I Study of Aprotinin in Advanced Breast Cancer	2006/07/20	NCT00354900	Phase 1	Terminated	Dartmouth-Hitchcock Medical Center
Effect of Aprotinin on Transfusion Requirements in Patients Undergoing Elective Spinal Fusion Surgery	2006/05/18	NCT00327379	Phase 3	Terminated	Bayer
Efficacy and Safety of Aprotinin on Transfusion Requirements in Patients Undergoing Radical or Total Cystectomy	2006/03/23	NCT00306150	Phase 3	Terminated	Bayer

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
TRASYLOL INJECTION 500,000 kiu/50 ml	BAYER PHARMA AG	SIN07805P	INJECTION	500000 kiu/50 ml	7/26/1994
TISSEEL FIBRIN SEALANT VH S/D (FROZEN)	Takeda Manufacturing Austria AG (Site: Industriestrasse 72), Takeda Manufacturing Austria AG (Site: Lange Allee 24F) (Primary Packager)	SIN14707P	SOLUTION	2250-3750 KIU/ml	12/22/2014
ARTISS SOLUTIONS FOR SEALANT, DEEP FROZEN	Takeda Manufacturing Austria AG (Site: Industriestrasse 72), Takeda Manufacturing Austria AG (Site: Lange Allee 24B), Takeda Manufacturing Austria AG (Site: Lange Allee 24A) (Primary and Secondary Packager)	SIN14719P	SOLUTION	2250 – 3750 KIU/ml	1/6/2015
BERIPLAST P COMBI-SET 3ML POWDERS AND SOLVENTS FOR SEALANT	CSL Behring GmbH	SIN16776P	OTHER	3000KIU	5/10/2023
BERIPLAST P COMBI-SET 1ML POWDERS AND SOLVENTS FOR SEALANT	CSL Behring GmbH	SIN16775P	OTHER	1000KIU	5/10/2023

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
TRASYLOL 2,000,000 KIU/200mL	58867	Link Medical Products Pty Ltd T/A Link Pharmaceuticals	Medicine	A	6/3/1997
ARTISS fibrin sealant VH S/D 4 IU (frozen) solution for sealant syringe	163515	Baxter Healthcare Pty Ltd	Medicine	A	8/19/2010
TISSEEL VH S/D fibrin sealant syringe	147141	Baxter Healthcare Pty Ltd	Medicine	A	3/13/2009
TRASYLOL 500,000KIU/50mL injection vial	43530	Link Medical Products Pty Ltd T/A Link Pharmaceuticals	Medicine	A	8/2/1993
TRASYLOL Aprotinin 1,000,000 KIU/100mL	58869	Link Medical Products Pty Ltd T/A Link Pharmaceuticals	Medicine	A	6/3/1997

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
TISSEEL KIT VH 5.0	osterreichisches institut fur haemoderivate ges m.b.h.	01974327	Powder For Solution - Topical	3000 UNIT / ML	12/31/1992
TISSEEL KIT VH 2.0	osterreichisches institut fur haemoderivate ges m.b.h.	01949012	Powder For Solution - Topical	3000 UNIT / ML	12/31/1992
TISSEEL KIT VH	osterreichisches institut fur haemoderivate ges m.b.h.	00677558	Jelly - Topical	3000000 UNIT / PCK	12/31/1986
TISSEEL KIT VH 5.0	Baxter AG	02233275	Liquid , Kit , Powder For Solution - Topical	15000 KIU / 5 ML	10/13/1998
TISSEEL KIT VH 1.0	Baxter AG	02233273	Kit , Liquid , Powder For Solution - Topical	3000 KIU / 1 ML	10/13/1998
TISSEEL KIT VH 1.0	osterreichisches institut fur haemoderivate ges m.b.h.	01949020	Powder For Solution , Liquid - Topical	300 UNIT / ML	12/31/1992
TISSEEL KIT VH 0.5	osterreichisches institut fur haemoderivate ges m.b.h.	02017229	Powder For Solution , Liquid - Topical	3000 UNIT / ML	12/31/1992
TRASYLOL	Nordic Group BV	02186845	Solution - Intravenous	10000 UNIT / ML	12/15/1997
TISSEEL KIT VH 0.5	Baxter AG	02233272	Powder For Solution , Liquid , Kit - Topical	0.5 ML / VIAL	1/20/1998
TISSEEL KIT VH 2.0	Baxter AG	02233274	Liquid , Kit , Powder For Solution - Topical	6000 KIU / 2 ML	10/13/1998

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
TISSEEL SOLUCIONES PARA ADHESIVO TISULAR	Baxter S.L.	78896	SOLUCIÓN PARA ADHESIVO TISULAR	Uso Hospitalario	Commercialized
ARTISS SOLUCIONES PARA ADHESIVO TISULAR, ULTRACONGELADAS	Baxter S.L.	70914	SOLUCIÓN PARA ADHESIVO TISULAR	Uso Hospitalario	Commercialized

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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