Effect of hematopoietic growth factors therapy on brain injury

Establishment of clinical basis for hematopoietic growth factors therapy in brain injury

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0008633

Enrollment

Registered

2023-07-18

Start date

2018-07-09

Completion date

Unknown

Last updated

2023-08-01

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

Conditions

None listed

Interventions

Drug : The intervention group will receive a medication consisting of EPO (300 U/kg) + G-CSF (10 µg/kg), administered once a day for 5 consecutive days as a single intervention cycle. The control grou

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: In terms of subject selection criteria, the following conditions apply: 1) Adults aged 19 and above who are capable of providing voluntary consent, 2) Individuals with brain injuries occurring after the acute phase (one week after brain injury) such as ischemic brain injury, hypoxic-ischemic brain injury, hemorrhagic brain injury 3) Individuals who, according to the attending physician, are clinically eligible for re-enrollment in the study at least 6 months after the last hematopoietic growth factor injection.

Exclusion criteria

Exclusion criteria: The exclusion criteria for the subjects are as follows: 1) Individuals under the age of 19 who are incapable of providing voluntary consent, 2) Presence of cerebral lesions such as tumors or infections, 3) Use of anticoagulant warfarin (coumadin) (excluding medications from the antiplatelet drug class), 4) Leukopenia, thrombocytopenia, polycythemia, 5) History of malignant disease or myeloproliferative disorders, 6) Septic embolism, malignant hypertension, hyperkalemia, 7) Hepatic or renal dysfunction; serum creatinine > 3 mg/dl, 8) Allergy to erythropoietin or G-CSF medications, 9) Exclusion criteria for MRI examination, 10) Pregnant or breastfeeding women, 11) Body temperature above 38 degrees Celsius, presence of pneumonia on chest radiography, 12) Recurrent pneumonia symptoms, 13) Blood pressure exceeding 140/90 mmHg despite the use of antihypertensive medications, 14) Hemoglobin levels exceeding 15 g/dL. Individuals meeting any of these criteria will be excluded from the target group.

Design outcomes

Primary

Measure	Time frame
Systolic Blood Pressure;Diastolic Blood Pressure;Pulse Rate;Complete Blood Test;Erythropoietin;CD34+	—

Secondary

Measure	Time frame
Manual Muscle Testing;Rang of Motion;Modified Ashworth Scale;Modified Barthel index;Functional independence measure;Grip and Pinch Power;Box and Block Test;Jebsen Taylor Hand Function Test	—

Countries

Korea, Republic of

Contacts

Public ContactJihye Hwang

Yonsei University Health System, Severance Hospital

elysehwang.62@gmail.com+82-2-2228-0745

Outcome results