sCD163 in HELLP Syndrome

Not yet recruiting

• Conditions: HELLP Syndrome Complicating Pregnancy

• Registration Number: NCT07209748
• Lead Sponsor: Assiut University

Brief Summary

Primary Aim:

\_To investigate the diagnostic potential of soluble CD163 (sCD163)as a novel biomarker for the early detection of HELLP syndrome, assessing its sensitivity and specificity compared to current diagnostic markers.

Secondary Aims:

1. To evaluate the correlation between sCD163 levels and the clinical severity of HELLP syndrome, including complications such as liver dysfunction, thrombocytopenia, and hemolysis.

2. To compare sCD163 levels across different stages of HELLP syndrome (partial vs. complete and other hypertensive disorders of pregnancy (e.g., preeclampsia).

Detailed Description

\_HELLP syndrome, also known as the syndrome of hemolysis, elevated liver enzymes, and low platelets, represents a sever pregnancy complication typically associated with hypertension. HELLP occurs in 0.2-0.8% of pregnancies and in 70-80% of cases, it coexists with preeclampsia (PE) with a 0-24% mortality rate .Both conditions are classified as hypertensive diseases of pregnancy (HDP), and their pathogenesis has been linked to an excessive maternal inflammatory response, accompanied by enhanced endothelial activation. Erythrocytes are damaged as they pass through blood vessels with impaired endothelium and fibrin strands, resulting in microangiopathic hemolytic anemia (MAHA). Lactate dehydrogenase (LDH) concentration may rise as a consequence of hemolysis. Free hemoglobin binds to unconjugated bilirubin in the spleen or haptoglobin in plasma. Low serum haptoglobin is a characteristic in HELLP women. Patients whose pregnancies are complicated by HELLP syndrome are at a higher risk for renal failure, consumptive coagulopathy, placental abruption, pulmonary and cerebral edema, subcapsular liver hematoma, and hypovolemic shock. Maternal-fetal inflammatory responses were another critical theme , demonstrating that maternal inflammation extends to the fetal compartment, as evidenced by elevated uric acid and CRP in neonates of PE mothers predisposing offspring to long-term metabolic and cardiovascular risks. Soluble clusters of differentiation (sCD163) is a marker of activated macrophages, and its role is to modulate inflammatory reactions. sCD163 stands out as a valuable biomarker, commonly correlates the progression or the severity of several pathological conditions with its levels in tissue fluids, serum, or plasma. It's derived from enzymatic cleavage of cd163 enhanced by inflammatory response or oxidative stress. The primary function attributed to sCD163, similar to CD163, is the absorption and elimination of unbound hemoglobin, thereby reducing oxidative damage caused by heme radicals, since free hemoglobin in the blood stream can contribute to oxidative stress and tissue damage. The scavenging function of sCD163 helps to mitigate these effects. It has been demonstrated that sCD163 and immunoglobulin G interact with the free HB in plasma, leading to monocytic endocytosis of the sCD163-Hb-IgG complex via the Fcγ receptor (FcγR).

Several studies reported significant associations between inflammatory biomarkers and the risk of PE correlating with disease severity, systolic blood pressure, and proteinuria. In our study, we will test levels of sCD163 in pregnant women at different degrees of HELLP syndrome to discover their relationship\& its role in early detection of the syndrome.

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-09-30
• Study First Submitted QC: 2025-09-30
• Last Update Submitted: 2025-09-30
• Study First Posted: 2025-10-07
• Last Update Posted: 2025-10-07
• Study Start: 2025-12-01
• Primary Completion: 2026-12
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 70

Inclusion Criteria

• HELLP Syndrome Group:

  1. Pregnant women meeting complete HELLP criteria:

     • Hemolysis (LDH >600 U/L + abnormal smear or bilirubin ≥1.2 mg/dL)
     • AST/ALT ≥70 U/L
     • Platelets <100,000/μL

  2. Gestational age (20-42) weeks

• Control Group:

  1. Normotensive pregnant women (BP <140/90 mmHg, no proteinuria).
  2. Gestational age-matched

Exclusion Criteria

1. Chronic medical conditionsaffecting sCD163 levels:

   • Autoimmune diseases (e.g., lupus, rheumatoid arthritis)
   • Chronic kidney/liver disease
   • Active infections (e.g., HIV, hepatitis)

2. Fetal anomalies or intrauterine fetal demise at diagnosis.

3. Use of immunosuppressive therapies (e.g., corticosteroids beyond standard HELLP management).

4. Incomplete clinical/laboratory data for HELLP classification.

5. Other gestational disease such as gestational DM

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of sCD163 level in the 2 study groups	baseline	To investigate the diagnostic potential of soluble CD163 (sCD163)as a novel biomarker for the early detection of HELLP syndrome, assessing its sensitivity and specificity compared to current diagnostic markers and evaluate the correlation between sCD163 levels and the clinical severity of HELLP syndrome