Hemolysis in Patients With Hereditary Spherocytosis (HS)

NCT01201174 | Unknown

• 1 other identifier: SH-01CTIL
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

In the present study the investigators are going to explore the oxidative status of HS-RBC and its contribution to hemolysis

Conditions

Hereditary; Hemolysis

Keywords

Hemolysis in Patients with Hereditary Spherocytosis; with documented family history of HS.; spherocyte morphology,; splenomegaly and non-immune mediated hemolysis.

Outcome Measures

Primary Outcomes (1)

• ROS, reduced glutathione (GSH) and lipid peroxides will be measured in RBC

  ROS, reduced glutathione (GSH) and lipid peroxides will be measured in RBC following incubation with with 100 μM 2'-7'-dichlorofluorescin diacetate, 40 μM \[1-(4-chloromercuryphenyl-azo-2-naphthol)\] and fluor-DHPE, respectively for ROS \[8\] and with mercury orange for GSH \[9\]. After being washed twice, the cells will be resuspended in PBS and analyzed by flow cytometry .

  year

Secondary Outcomes (1)

• Hemolysis

  year

Study Arms (1)

Patients with Hereditary Spherocytosis

NO INTERVENTION

All patients should have clinical and laboratory findings, consistent with mild to severe HS, diagnosed on the basis of spherocyte morphology, elevated MCHC (33-38 g/dl), with a mean value of (35.47 g/dl), increased osmotic fragility , splenomegaly and non-immune mediated hemolysis.

Other: fermented papaya preparation (FPP)

Interventions

fermented papaya preparation (FPP) OTHER

Hemolysis will be assayed by suspending 3 ml of packed RBC in PBS or in the autologous plasma and overnight incubation in the presence of various concentrations of antioxidants such as fermented papaya preparation (FPP) at 37oC in humidified atmosphere of 5% CO2 in air (10). Following 5 min centrifugation at 800 rpm, the supernatants will collected for Hb determination by measuring the absorbance at 540 nm.

Patients with Hereditary Spherocytosis

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• patients \> 5 years
• with documented family history of HS
• patients should have clinical and laboratory findings, consistent with mild to severe HS, diagnosed on the basis of spherocyte morphology, elevated MCHC (33-38 g/dl), with a mean value of (35.47 g/dl), increased osmotic fragility , splenomegaly and non-immune mediated hemolysis.

You may not qualify if:

• non

Sponsors & Collaborators

• Wolfson Medical Center: lead

Study Sites (1)

Wolfsson Medical Center

Holon, Israel,, Israel

Location

MeSH Terms

Conditions

Hemolysis; Splenomegaly

Interventions

fermented papaya preparation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hypertrophy; Pathological Conditions, Anatomical

Study Officials

• GHOTI HOSSAM, doctor

  HEMATOLOGY DEPARTMENT ON WOLFSSON MEDICAL CENTER

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ghoti Hossam, doctor

CONTACT

035028110; drghoti123@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 12, 2010
• First Posted: September 14, 2010
• Study Start: September 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: September 14, 2010

Record last verified: 2010-09

Locations

IL (1)