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

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

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT1051210147
Enrollment
140
Registered
2022-01-05
Start date
2022-03-30
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Valvular heart disease,aortic aneurysm,aortic dissection,coronary artery disease Cardiovascular surgery ,cardiopulmonary bypass,hemolysis

Interventions

Haptoglobin should be administered if the free hemoglobin level measured perioperatively more than 50 mg/dL.

Sponsors

Hokka Mai
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
The difference between a preoperative creatinine level and a maximum creatinine level within 48 hours after surgery

Secondary

MeasureTime frame
(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

Contacts

Public ContactMai Hokka

Kobe University Hospital

smiamiam@yahoo.co.jp+81-78-382-6172

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026