A Multicenter, Open label, Parallel Controlled trial of recombinant human thrombopoietin (rhTPO) for patients with severe sepsis and thrombocytopenia

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IPR-15006986

Enrollment

Unknown

Registered

2015-07-27

Start date

2011-09-15

Completion date

Unknown

Last updated

2017-04-18

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

Conditions

thrombocytopenia

Interventions

rhTPO:rhTPO 300 U/kg, subcutaneous injection once daily, period of treatment is equal to or less than 5 days. If the platelet count >100*10^9 / L or the platelet count increased absolute value is more

Intravenous immune globulin (IVIg):IVIg 400mg/kg/d, *5d

Eligibility

Sex/Gender

All

Age

14 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Male and female aged 14 to 75 years old; (2)The criteria for severe sepsis were a modification of those defined by surviving sepsis campaign. Detailedly, SIRS was defined by 2 or more of the following conditions: temperature higher than 38 degree C or lower than 36 degree C, heart rate more than 90 beats/min, respiratory rate more than 20 breaths/min or PaCO2 less than 4.26 kPa, or white blood cell (WBC) count greater than 12*10^9/L or less than 4*10^9/L. Also, sepsis was defined as a systemic response to infection including the criteria of SIRS plus microbiological evidence of a focal infection and/or a positive blood culture; (3) All hospitalized septic patients whose PCs were less than 50*10^9/L at their admission were eligible for inclusion.

Exclusion criteria

Exclusion criteria: (1) Patients who were prescribed chemotherapeutic before or in our study; (2) Patients who were prescribed immunomodulators in last 6 months; (3) After cardiopulmonary resuscitation; (4) Death or rransferred cases admitted into hospital within 24 hours; (5) End-stage liver or renal failure (Cr>442umol/L); (6) Thrombocytopenia in blood diseases; (7) Serious cardiovascular and cerebrovascular diseases; (8) History of thromboembolic disease in last 2 months; (9) Bleeding; (10) Patients atients who were prescribed antiplatelet drugs in last 2 weeks (GPIIb/IIIa antagonists); (11) Patients atients who were prescribed heparin in last 2 weeks.

Design outcomes

Primary

Measure	Time frame
Tertiary A Hospital;blood biochemistry;	—

Countries

China

Contacts

Public ContactYongqiang Wang

egenbing@163.com+86 022-23626048

Outcome results

None listed

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