Association between haptoglobin administration based on free hemoglobi n levels during cardiac surgery and postoperative renal dysfunction

The effect of haptoglobin administration based on free hemoglobin conce ntration in cardiac surgery patients on postoperative renal function: a randomized controlled trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1051250247

Enrollment

Registered

2026-03-06

Start date

2026-04-01

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 diss ection,coronary artery disease Cardiovascular surgery ,cardiopulmonary bypass,h emolysis

Interventions

In both groups, administer haptoglobin when hemolytic urine is observed. If hemolytic urine persists 30 minutes after completion of the previous administration, an addi tional dose of haptoglobin wil

Haptoglobin

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients undergoing elective cardiac surgery usi ng cardiopulmonary bypass 2.Patients aged 18 years or older at the time of co nsent 3.Patients who have given their free and informed written consent to participate in this clinical study

Exclusion criteria

Exclusion criteria: 1.Patients requiring dialysis treatment prior to sur gery 2.Patients with serum creatinine levels of 2 mg/dL or higher prior to surgery 3.Patients scheduled for surgery involving the des cending aorta 4.Patients scheduled for surgery involving cardiac arrest 5.Patients with haptoglobin deficiency 6.Patients with IgA deficiency 7.Patients with liver dysfunction (bilirubin > 2 mg /dL) 8.Patients with hemolytic disorders (such as autoi mmune hemolytic anemia, paroxysmal nocturnal h emoglobinuria, or hereditary spherocytosis) 9.Patients with immunodeficiency or immunosuppression (currently using immunosuppressive agents or who have undergon e chemotherapy within the past year) 10.Pregnant patients 11.Other patients deemed inappropriate by the cl inical research investigator

Design outcomes

Primary

Measure	Time frame
Difference between preoperative serum creatinine (Cr) level and maximum serum creatinine level wit hin 48 h postoperatively	—

Secondary

Measure	Time frame
Serum free hemoglobin concentration at each me asurement point during the perioperative period. Haptoglobin concentration at each measurement point during the perioperative period. Serum creatinine value at each measurement point. Presence and severity of postoperative organ dysfunction. incidence of dialysis initiation. The incidence proportion of investigational drug related adverse events occurring from the day of surgery through the observation period among study subjects who received protocol treatment out of all enrolled patients.	—

Measure

Time frame

Serum free hemoglobin concentration at each me asurement point during the perioperative period. Haptoglobin concentration at each measurement point during the perioperative period. Serum creatinine value at each measurement point. Presence and severity of postoperative organ dysfunction. incidence of dialysis initiation. The incidence proportion of investigational drug related adverse events occurring from the day of surgery through the observation period among study subjects who received protocol treatment out of all enrolled patients.

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Contacts

Public ContactAtsushi Miyazaki

Kobe University Hospital

atsmiya0614@gmail.com+81-78-382-5111

Outcome results

None listed

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