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

JRCT ID: jRCT1051210147

Registered date:05/01/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Valvular heart disease,aortic aneurysm,aortic dissection,coronary artery disease
• Date of first enrollment: 30/03/2022
• Target sample size: 140
• Study type: Interventional
• Intervention(s): Haptoglobin should be administered if the free hemoglobin level measured perioperatively more than 50 mg/dL.

Outcome(s)

• Primary Outcome: The difference between a preoperative creatinine level and a maximum creatinine level within 48 hours after surgery

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Hokka Mai
• Source(s) of Monetary Support: Grants-in-Aid for Scientific Research