NCT05223361 is a Phase 3 clinical trial of Six percent hydroxy ethyl starch 130/0.4 in Heart Valve Diseases, sponsored by Rajaie Cardiovascular Medical and Research Center.

Who is sponsoring NCT05223361?

NCT05223361 is sponsored by Rajaie Cardiovascular Medical and Research Center.

What drugs are being tested in NCT05223361?

Interventions in NCT05223361: Six percent hydroxy ethyl starch 130/0.4, Ringer lactate.

What condition does NCT05223361 study?

NCT05223361 studies Heart Valve Diseases.

Is NCT05223361 still recruiting?

NCT05223361 is currently completed. Last updated 23 January 2022.

Last reviewed 2022-01-23 · How we verify

NCT05223361

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Cardiopulmonary Bypass Prime Solution in Patients Undergoing Heart Valve Surgery

Completed Phase 3 Last updated 23 January 2022

What this trial tests

Phase 3 trial testing Six percent hydroxy ethyl starch 130/0.4 in Heart Valve Diseases in 120 participants. Completed in 30 November 2021.

Timeline

1 April 2016

Primary endpoint
30 April 2021

30 November 2021

Quick facts

Lead sponsor	Rajaie Cardiovascular Medical and Research Center
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	120
Start date	1 April 2016
Primary completion	30 April 2021
Estimated completion	30 November 2021
Sites	1 location across Iran

Drugs / interventions tested

Six percent hydroxy ethyl starch 130/0.4 — full drug profile →
Ringer lactate

Conditions studied

Heart Valve Diseases — all drugs for Heart Valve Diseases →

Sponsor

Rajaie Cardiovascular Medical and Research Center — full company profile →

Who can join

Adults 18 to 75, any sex, with Heart Valve Diseases. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Number of participants required blood transfusion
Time frame: Up to discharge, an average of 8 days
The volume of blood transfusion after heart valve surgery

Sponsor's own description

In this randomized clinical trial, patients with undergoing open heart valve surgery will be enrolled into the study. Participants will be divided into two groups based on the priming solution type. The first group will receive hydroxyethyl starch (HES) 130/0.4 additive to ringer lactate (RL) and the second group will be given only RL as priming solution. All patients will be observed closely during postoperative days. Through follow up, bleeding/coagulopathy, renal function, hepatic function, and cerebral oxygenation will be recorded in both groups.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Heart Valve Diseases

Currently open trials in the same condition.

NCT07390903 — GLS in Difficult CPB Weaning · recruiting
NCT07099859 — Effect of Losartan on the Neurohumoral Axis and Ventricular Remodeling of Patients With Severe Aortic Regurgitation Unde · Phase 4 · recruiting
NCT06215378 — Antagonization of Heparin With Protamine Sulfate After TAVI · Phase 3 · recruiting
NCT06445231 — Echocardiography in Nursing Home · NA · recruiting
NCT06569602 — Real World European Investigation of Safety and Clinical Efficacy of the EVOQUE System (TRISCEND III EU) · recruiting

Other Rajaie Cardiovascular Medical and Research Center trials

Trials by the same sponsor.

NCT06541691 — Coated or Chewable Aspirin and a Hybrid Strategy to Mitigate Adverse Effects of Air Pollution in Stable Atherosclerotic · NA · recruiting
NCT06124937 — Empagliflozin to Prevent Post-Operative Atrial Fibrillation · Phase 3 · unknown
NCT04486508 — Intermediate-dose vs Standard Prophylactic Anticoagulation and Statin vs Placebo in ICU Patients With COVID-19 · Phase 3 · completed
NCT05705089 — Rivaroxaban vErsus Warfarin for Antithrombotic TheRapy in Patients With LeFt Ventricular Thrombus After Acute STEMI · Phase 3 · completed
NCT04304118 — Rajaie Cardiomyopathy and Myocarditis Registry · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05223361 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Rajaie Cardiovascular Medical and Research Center
Last refreshed: 23 January 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05223361.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing