Trial intelligence / Profile preview

Bovine vs Porcine Heparin in Cardiovascular Surgery

NCT01072747Phase 3

Key facts

Status: Unknown
Start: Apr 2010
Primary completion: Aug 2011
Countries: 1
Sponsor: Azidus Laboratories Limited
Modality: Biologic

Drugs: Actiparin
Conditions: cardiovascular disease (CVD)

Overview

Phase 3, randomised, double-blind trial of Actiparin in cardiovascular disease (CVD) (2 arms), sponsored by Azidus Laboratories Limited. Primary endpoints: Activated Clotting Time, Activated Partial Thromboplastin Time and 2 more. Status: unknown.

Design

2 arms

Study design: RandomizedDouble-blind

Bovine Heparin
Actiparin (Bovine Heparin)
Porcine Heparin
Porcine Heparin (APP Pharmaceuticals)

Who it enrols

Adult patients undergoing cardiac surgery requiring cardiopulmonary bypass, excluding those with hematological disorders, renal or liver impairment, or recent use of antiplatelets/anticoagulants.

Endpoints

Primary

Activated Clotting TimePostoperative
Activated Partial Thromboplastin TimePostoperative
Anti-Xa heparin levelsPostoperative
Excessive blood loss (hemorrhage)Postoperative

Secondary

Value of the total dose of heparin usedIntraoperative period
Adequate reversal with the use of protaminePostoperative

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