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Hemolysis after Transfusion of Packed Red Blood Cells by Peripherally Inserted Central Catheter in neonates: randomized clinical trial

Alteration of Hemolysis markers in Packed Red Blood Cell Transfusion using PICC in newborns: randomized clinical trial - PICC Peripherally Inserted Central Catheter

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-6vb9gn4
Enrollment
Unknown
Registered
2022-11-22
Start date
2023-02-01
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

hemolysis

Interventions

Newborns hospitalized in the Neonatology Service, in need of transfusion of Concentrated Red Blood Cells (pRBCs) will participate in the research. These will be included in the research when there is
E02.095.135.140.275

Sponsors

Hospital de Clínicas da Universidade Federal do Paraná
Lead Sponsor
Hospital de Clínicas da Universidade Federal do Paraná
Collaborator

Eligibility

Age
1 Days to 28 Days

Inclusion criteria

Inclusion criteria: Newborns with Peripherally Inserted Central Catheter (PICC) admitted to the Neonatology Service; both sexes with a medical prescription for transfusion of packed red blood cells (pRBCs)

Exclusion criteria

Exclusion criteria: Newborn who has not had blood collected within 24 hours after transfusion; Newborns diagnosed with hemolytic disorders; Newborns receiving vasoactive drug in a single monolumen Peripherally Inserted Central Catheter (PICC); Newborns receiving Total Parenteral Nutrition with osmolarity above 900 milliosmol(mOsm) in a single mono lumen PICC

Design outcomes

Primary

MeasureTime frame
The change in hemolysis markers after CH administration will be considered as the outcome of this research. The markers analyzed will be Hematocrit (HcT), Total Hemoglobin (Hb), Free Hemoglobin (HbL), Potassium (K) and the calculation of the degree of hemolysis will be carried out. It is worth mentioning that to obtain the results of the markers (Hematocrit, Total Hemoglobin and Potassium), the result of the control blood gas analysis performed in hospitalized neonates will be used. These analyzes will be performed by the researcher/collaborator using the Automatic Blood Gas Analyzer Model: Rapidpoint 500e®, available at the NICU, located on a bench next to the nursing station. And for the analysis of the level of free hemoglobin, absorption spectrophotometry will be performed on a laboratory bench and the remaining sample from the routine collection will be used. It is also noteworthy that the hemolysis markers will be analyzed in three samples. Sample 1 refers to the blood sample of the NB collected pre-transfusion, sample 2 will be the sample collected from the CH bag after installation in the infusion pump and filling the equipment, and before the transfusion and sample 3 refers to the sample collected from the NB 24h after the transfusion. Subsequently, based on the appropriate parameters, the degree of hemolysis (%) will be calculated using the following equation: % Hemolysis: Free hemoglobin (g/L) × (100 - hematocrit (%))/Total hemoglobin.

Secondary

MeasureTime frame
Secondary outcomes are not expected

Countries

Brazil

Contacts

Public ContactMaria de Brito Cunha

Complexo Hospital de Clínicas

goretebrito1982@gmail.com+55(41) 3360-1800

Outcome results

None listed

Source: REBEC (via WHO ICTRP)