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Multi-center, randomized, open, clinical study of hemocoagulase Atrox for injection (baquting) for Selective patients with meningioma and gliomas during Preoperative

Multi-center, randomized, open, clinical study of hemocoagulase Atrox for injection (baquting) for Selective patients with meningioma and gliomas during Preoperative

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-11001322
Enrollment
Unknown
Registered
2011-03-10
Start date
2011-04-01
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

Meningioma and gliomas

Interventions

A:Iv a dose of 1U hemocoagulase before operation 30min ago, local use with Gelfoam (2U hemocoagulase +10 ml saline) by infiltration, a dose of 1U hemocoagulase after
B:Iv a dose of 2U hemocoagulase before operation 30min ago, local use with Gelfoam (4U hemocoagulase +10 ml saline) by infiltration, a dose of 2U hemocoagulase after
C:None Hemostatic drug

Sponsors

China Nuokang Bio-pharmaceutical INC.
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 65 years old , sex is not limited; 2. Neurosurgery elective patients with meningioma or glioma patient, (ASA) score I-II level; 3. 2-6cm convexity meningioma or single supratentorial gliomas; 4. Agree to Surgical indications of Heart & lung and without the coagulation system disease; 5. Hb, PLT, PT, INR, APTT agree to Surgical indications; 6. Able and willing to provide signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Irritable the physique or allergy to hemocoagulase Atrox; 2. Had use drug about coagulation system in two weeks, such as Aspirin, clopidogrel, Ticlopidine, Dipyridamole, Ginkgo Bi loba Leaf, heparin, Warfarin, citrate, hemocoagulase Atrox, Vk, Anti- fibrinolytics, Etamsvlatum, Vc; 3. Metastatic Tumors; 4. Systemic disease such as un-controlled hypertension, TB, un-controlled diabetes, un-controlled Hepatology, other diseases may interfere with study participation or evaluation; 5. Anaemia or disturbance of blood coagulation; 6. History of thrombosis or thrombophilia by checked or serious blood disorders; 7. Pregnant or lactating women; 8. Have join in other clinical study in four weeks; 9. Poor compliance; 10. Researcher think who can't complete the study.

Design outcomes

Primary

MeasureTime frame
hemorrhage volume in operation;

Countries

China

Contacts

Public ContactBin Zhou
zhoubin@nkbp.com+86 10 65330052

Outcome results

None listed

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