Aprotinin Clinical Trials

Size	Price	Qty
10mg	USD 147
50mg	USD 347

Clinical Trials

Numerous clinical trials evaluate aprotinin from Phase 1 through Phase 4 across diverse indications, including surgical blood loss, ischemic heart disease, thrombosis during coronary artery bypass, metastatic breast cancer, COVID-19, and pancreatitis. Sponsored by both academic institutions and commercial entities, these studies reflect recruitment statuses spanning completed, recruiting, terminated, and unknown.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07317050	RECRUITING	Acute Respiratory Distress Syndrome (ARDS)	Fundacion del Hospital Nacional de Paraplejicos para la Investigacion y la Integracion	2026-06-18	PHASE3
NCT04527133	UNKNOWN	COVID-19	Aviron LLC	2020-06-11
NCT02545153	UNKNOWN	Common Bile Duct Gall Stones; Infection; Bile Leak	Lasarettet i Enköping	2009-01	PHASE2
NCT01436734	COMPLETED	Hyperglucagonemia	University Hospital, Gentofte, Copenhagen	2011-07
NCT00892957	COMPLETED	Hemostasis in Participants Receiving Peripheral Vascular Expanded Polytetrafluoroethylene (ePTFE) Graft Prostheses	Baxter Healthcare Corporation	2009-07	PHASE3
NCT00681824	COMPLETED	Pathological Processes in the Posterior Fossa; Dura Defects	Baxter Healthcare Corporation	2008-05	PHASE2
NCT00708071	COMPLETED	Facial Rhytidectomy (Face-lift)	Baxter Healthcare Corporation	2008-06	PHASE2
NCT00257751	COMPLETED	Coronary Artery Disease	Oslo University Hospital	2004-03
NCT00327379	TERMINATED	Blood Loss, Surgical; Postoperative Hemorrhage	Bayer	2006-02-27	PHASE3
NCT00481806	Unknown status	Coronary Artery Bypass\|Thrombosis	University of Arizona\|University of Maryland Baltimore County	2007-02	--
NCT00354900	Terminated	Metastatic Breast Cancer	Dartmouth-Hitchcock Medical Center	2006-07	Phase 1
NCT00668031	COMPLETED	Blood Loss, Surgical	Bayer	2005-02	PHASE3
NCT00131040	Completed	Ischemic Heart Disease\|Angina Pectoris	Imperial College London\|British Heart Foundation	2003-01	Not Applicable
NCT00354900	TERMINATED	Metastatic Breast Cancer	Dartmouth-Hitchcock Medical Center	2006-07	PHASE1
NCT00131040	COMPLETED	Ischemic Heart Disease; Angina Pectoris	Imperial College London	2003-01
NCT00306137	TERMINATED	Blood Loss, Surgical	Bayer	2005-12	PHASE3
NCT00357851	COMPLETED	Pancreatitis	Nemours Children's Clinic	2005-03	PHASE1
NCT00396760	UNKNOWN	Bleeding and Cardiac Surgery; Allogeneic Blood Transfusion; Aortic Valve Replacement; Coronary Artery Bypass Graft Surgery	German Heart Center	2005-01	PHASE3
NCT00395369	UNKNOWN	Cardiac Surgery	Soroka University Medical Center	2007-12
NCT00306150	TERMINATED	Blood Loss, Surgical; Postoperative Hemorrhage	Bayer	2005-12	PHASE3
NCT00290836	COMPLETED	Control of Local Bleeding in Patients Undergoing Prostatectomy.	Nycomed	2004-05	PHASE4

(data from https://clinicaltrials.gov, updated on 2026-07-15)

Check the Aprotinin product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Aprotinin acts as a potent serine protease inhibitor that binds directly to active enzyme sites, preventing the downstream proteolytic cleavage of protein substrates and inhibiting systemic fibrinolysis. This enzymatic blockade preserves fibrin clot integrity and attenuates inflammatory cascades, thereby reducing perioperative blood loss and improving surgical hemostasis in cardiovascular procedures.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).