A Randomized Controlled Trial of the Preventive Effect of Haptoglobin Administration on Hemolysis-Related Organ Damage in Patients undergoing Cardiovascular Surgery

Phase 3

Recruiting

• Conditions: D006349,D001014,D000784,D003324; Cardiovascular surgery ,cardiopulmonary bypass,hemolysis; Valvular heart disease,aortic aneurysm,aortic dissection,coronary artery disease

• Registration Number: JPRN-jRCT1051210147
• Lead Sponsor: Hokka Mai

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-05
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

1.Patients who undergo cardiovascular surgery required cardiopulmpnary bypass
2.Patients aged 20 years or older
3.Patients who have given written consent to participate in this study
4.Patients with a free hemoglobin concentration of more than 50 mg/dL within 2 hours of starting cardiopulmonary bypass

Exclusion Criteria

1.Patients who had already had renal replacemt therapy
2.Patients with a preoperative serum creatinine level of 2 mg/dl or higher
3.Patients scheduled for surgery involving the descending aorta
4.Patients who undergoing MICS (Minimum Invasive Cardiac Surgery)
5.Patients with haptoglobin deficiency
6.Patients with IgA deficiency
7.Patients with hepatic impairment(Bil>2.0mg/dL)
8.Patients with hemolytic diseases(Autoimmune haemolytic anaemia, paroxysmal nocturnal haemoglobinuria, hereditary spherocytosis, etc.)
9.Immunocompromised and immunosuppressed patients(e.g. patients on immunosuppressive drugs or who have used chemotherapeutic drugs for malignancy within the last year)
10.Patients who are deemed inappropriate by the study investigators

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The difference between a preoperative creatinine level and a maximum creatinine level within 48 hours after surgery

Secondary Outcome Measures

Name	Time	Method
(Efficacy Outcomes)<br>1.Perioperative free hemoglobin concentration at each measurement point<br>2.Perioperative serum haptoglobin concentration at each measurement point<br>3.Postoperative creatinine level at each measurement point and Incidence of postoperative renal failure(AKIN classification)<br>4.Perioperative renal function markers at each measurement point<br>5.Perioperative methemoglobin concentration at each measurement point<br>6.Presence and extent of postoperative organ injury<br>(Safety Outcomes)<br>Disease during the observation period<br>Incidence of complications<br>(Expolatory Outcome)<br>Perioperative NO concentration at each measurement point