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Early complementary acupuncture improves the clinical prognosis of traumatic brain edema:a randomized controlled trial

Phase 1
Conditions
traumatic brain injury traumatic brain edema
Registration Number
ITMCTR2100005353
Lead Sponsor
Qionghai People's Hospital, Hainan Province, China
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
All
Target Recruitment
Not specified
Inclusion Criteria

Adults with TBI who fulfill the following inclusion criteria are eligible:
(1)Initial GCS score between 6 and 12 points on admission.
(2)Patients who have one or more brain contusions with visible pericontusional
edema in the CT scan.
(3)Age 16 or over and under 75.
(4)Agree to acupuncture treatment that can start within 72?h after injury or
post-craniotomy.
(5)Signing of informed consent by his legal representative.

Exclusion Criteria

The exclusion criteria are the following:
(1)Patients whose vital signs are unstable within 72 hours of admission, or
(2)a severe medical disease, e.g.,heart, liver, renal failure or an autoimmune
disorder.
(3)Patients who have required a craniotomy before randomization for any
reason other than TBI.
(4)Patients with unsuitable for acupuncture, including pregnant , frequent
seizures, psychotic disorders, afraid of acupuncture, particularly weak, and skin infections at the acupuncture site, etc.
(5)Medication that need to treat coexisting diseases may affect the results of
the study.

Study & Design

Study Type
Interventional study
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Glasgow outcome score;
Secondary Outcome Measures
NameTimeMethod
Volume of traumatic brain edema;Glasgow Coma Scale (GCS);
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