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Study on the mechanism and safety evaluation of hyperhemopoiesis in human

Trial to validate the apheresis blood donation protocol (draft)

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076538
Enrollment
Unknown
Registered
2023-10-11
Start date
2022-10-25
Completion date
Unknown
Last updated
2023-10-16

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

Conditions

Healthy volunteers

Interventions

Group 1:4U (500ml±50ml) concentrated red blood cells plus 1 therapeutic amount (150ml±15ml) of platelets
Group 2:6U (500ml±50ml) concentrated red blood cells

Sponsors

The Fourth Medical Center of Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Age 18-55, male, weight =70kg;Peripheral blood erythrocyte (Hb) level =150g/L, hematocrit (Hct) =45%, platelet count =150'109/L;Blood pressure: 90mmHg= systolic blood pressure < 140mmHg, 60mmHg= diastolic blood pressure < 90mmHg, pulse pressure difference: =30mmHg;Pulse: 60 times /min ~ 100 times /min (high endurance athletes =50 times /min, rhythm is orderly);Normal body temperature;Normal cardiopulmonary function;The tests of alanine aminotransferase (ALT), hepatitis B virus (HBV), hepatitis C virus (HCV), HIV and Syphilis, which were all in line with the national standards for blood donation [Requirements for Health Examination of Blood Donors GB18467-2011].The results of blood donation health consultation, MMSE questionnaire, SF-36 brief health questionnaire, Hamilton Depression Scale and Hamilton Anxiety Scale were not abnormal.Physical examination is basically normal.

Exclusion criteria

Exclusion criteria: Abnormal or inhibited hematopoietic function of bone marrow ;cardiopulmonary insufficiency; fever or infectious diseases;taking drugs to inhibit compensatory cardiovascular response;taking drugs that promote or inhibit hematopoietic function;the history of whole blood donation within half a year does not meet the national standards for blood donation.

Design outcomes

Primary

MeasureTime frame
RBC;Hb;Hct;RET%;RET;IS;SF;PLT;Recovery time;

Countries

China

Contacts

Public ContactOuYang Xilin

The Fourth Medical Center of Chinese PLA General Hospital

ouy70304@163.com13381361899

Outcome results

None listed

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