---
title: A Clinical Prospective Observational Study of Near Infrared Spectroscopy to Detect Subcranial Hematoma
nct_id: NCT06404645
overall_status: RECRUITING
sponsor: RenJi Hospital
study_type: OBSERVATIONAL
primary_condition: Intracranial Hemorrhages
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06404645.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06404645"
ct_last_update_post_date: 2024-05-08
last_seen_at: "2026-05-12T07:12:29.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Clinical Prospective Observational Study of Near Infrared Spectroscopy to Detect Subcranial Hematoma

**NCT ID:** [NCT06404645](https://clinicaltrials.gov/study/NCT06404645)

## Key Facts

- **Status:** RECRUITING
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 20
- **Lead Sponsor:** RenJi Hospital
- **Conditions:** Intracranial Hemorrhages
- **Start Date:** 2024-05-01
- **Completion Date:** 2024-12-31
- **CT.gov Last Update:** 2024-05-08

## Brief Summary

This trial is a clinical prospective observational study. Cases meeting the entry criteria undergo near-infrared spectroscopy(NIRS）detection. Data collection mainly includes hematoma thickness on cranial CT, and bilateral NIRS data.This trial tries to explore the reliability and accuracy of NIRS detection of subcranial hematoma.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

1. Age above 18 years old
2. Unilateral subcranial hemorrhage confirmed by cranial CT

Exclusion Criteria:

1. Bilateral subcranial hemorrhage
2. Intracranial pneumoperitoneum in the location of the hemorrhage on cranial CT
3. Obvious skull fracture in the location of hemorrhage on cranial CT
```

## Interventions

- **Near-infrared spectroscopy detection** (DEVICE) — Cranial CT confirm intracranial haematoma. Then the near-infrared spectroscopy device to collect date by red sensor probe in the corresponding position on the scalp and blue sensor probe on the opposite side of the hematoma. Collect data for 10 minutes.

## Primary Outcomes

- **NIRS data1** _(time frame: 3 months)_ — NIRS data of bleeding side and the opposite side

## Secondary Outcomes

- **NIRS data2** _(time frame: 3 months)_

## Locations (1)

- Brain Injury Center, Renji Hospital, School of Medicine, Shanghai Jiao Tong University, Shanghai, Shanghai Municipality, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.brain injury center, renji hospital, school of medicine, shanghai jiao tong university|shanghai|shanghai municipality|china` — added _(2026-05-12)_

---

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