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A pilot to determine how blood salvage can serve Nigerian patients in need of blood transfusion

A controlled real-world trial of cell salvage by microfiltration in gynaecologic and obstetric care as pilot to implementation of a national autologous blood transfusion service in Nigeria

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN13556780
Enrollment
300
Registered
2024-03-29
Start date
2024-05-01
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

High-quality cell salvage in obstetric and gyneacologic patients with moderate to high risk of blood loss. Pregnancy and Childbirth

Interventions

Autologous transfusion of blood cells salvaged by microfiltration technology Participants in the intervention group will receive an autologous blood transfusion prepared by microfiltration cell salvag

Sponsors

National Blood Service Commission
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Undergoing obstetric or gynaecologic procedures 2. Ability to provide informed consent, direct or by a relative representative 3. Procedure with estimated blood loss of at least 500mL

Exclusion criteria

Exclusion criteria: 1. Sickle cell disease 2. Active malignancy contraindicated to cell salvage e.g. abdominal cancer 3. Excessive contamination of the wound field with bacterial contamination

Design outcomes

Primary

MeasureTime frame
Adoption of the autologous blood transfusion procedure measured using (1) surveys of the health care staff involved in the provision of the autologous blood, (2) autologous blood transfusion exam outcomes as recorded by the health care staff involved in the provision of the autologous blood and (3) participant enrolment rate, directly upon implementation and three months after implementation.

Secondary

MeasureTime frame
1. Volume of autologous blood processed as read from the volume indication on the blood infusion bag upon completion of the autologous blood processing. Upon completion of delivery or surgical procedure, the total volume of autologous blood processed is calculated by adding the volumes of all autologous blood units processed. 2. Volume of autologous blood reinfused as read from the volume indication on the blood infusion bag upon start of the autologous blood reinfusion. Upon completion of delivery or surgical procedure, the total volume of autologous blood reinfused is calculated by adding the volumes of all autologous blood units reinfused. 3. Estimated volume of blood loss as read from the volume indication on the blood collection device before processing of each blood unit. Upon completion of delivery or surgical procedure, the total volume of blood loss is calculated by adding the pre-processed volumes of all autologous blood units lost. 4. Patient blood haemoglobin measured by blood gas analysis before the reinfusion of the first autologous blood unit and after the reinfusion of the last autologous blood. 5. Units of additional donor blood transfused counted after delivery or surgical procedure 6. Processed autologous blood haemoglobin level, red cell count, platelet count and white blood cell count measured by a hematology analyzer complete blood count upon completion of processing of each autologous blood unit

Countries

Nigeria

Contacts

Public ContactAdetoun Kalejaiye
Kalejaiye.a@nbsc.gov.ng+2347088370905

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026