risk factors for sample hemolysis in blood collecting procedures for phase I and bioequivalence trials: a case control study

risk factors for sample hemolysis in nursing procedures for phase I and bioequivalence trials: a case control study

Status

Active, not recruiting

Phases

Phase 1

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2200063332

Enrollment

Unknown

Registered

2022-09-04

Start date

2022-09-05

Completion date

Unknown

Last updated

2023-04-17

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

Conditions

blood collecting procedures

Interventions

case group:Specimens of hemolysis

control group:Specimens without hemolysis

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: Data were obtained from five bioequivalence trials ,involving 14,707 blood specimens from 304 subjects,conducted in the Phase I ward of the First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine between January 2020 and May 2022.

Exclusion criteria

Exclusion criteria: those with missing data for more than 80% of the variables due to missing or obscured archived video were excluding.

Design outcomes

Primary

Measure	Time frame
working years of nurses;professional title of nurses;roles of nurse;Duration of indwelling needle use;Whether the indwelling needle is indwelled on the hand side;the use of tourniquet;Adjust the indwelling needle Angle;transfer of blood sample;Rate of blood withdrawal;Time between blood discarding and PK blood;technique of waving tube;	—

Countries

China

Contacts

Public ContactQiuhan Cai

The First teaching hospital of Tianjin university of traditional Chinese medicine

happyqiuhan@126.com+86 13821411339

Outcome results

None listed

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