Health TrialsbyHealthPanel

rhTNK-tPA Thrombolytic Removal of Intraventricular Hemorrhage

ConditionIntraventricular Hemorrhage
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBeijing Tiantan Hospital

About this trial

The purpose of this pilot study is to determine the safety and optimal dose of clot lysis with rhTNK-tPA for intraventricular hemorrhage, using stereotactic guidance for extraventricular drain placement.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-80 years.

Symptom onset within 24 hours prior to diagnostic CT scan. Patients with unknown onset time should be excluded. For patients with symptoms occurring during sleep, the time of symptom onset should be considered as the last time the patient was awake and asymptomatic.

Spontaneous intracerebral hemorrhage (ICH) ≤ 30 ml，with intraventricular hemorrhage (IVH) >20 ml obstructing the third and/or fourth ventricles.

All patients must have an external ventricular drain (EVD) placed prior to enrollment: The EVD should be accurately positioned into the largest cerebrospinal fluid (CSF) pool or the least bloody site in the lateral ventricle using robotic stereotactic guidance.

Disqualifiers

Hemorrhage caused by aneurysms, arteriovenous malformations (AVM), tumors, or other identifiable causes. If the cause of ICH is unknown, CTA, DSA, or other definitive imaging must be performed during screening to rule out these causes. If imaging is negative, the patient is eligible.

Presence of choroid plexus vascular malformation or Moyamoya disease.

Hypercoagulable state or coagulopathy. Patients requiring long-term anticoagulation are excluded. Reversal of anticoagulation is permitted if long-term anticoagulation is not required.

Use of anticoagulants (e.g., dabigatran, apixaban, rivaroxaban) or antiplatelet agents (e.g., tirofiban, ticagrelor, cilostazol, clopidogrel) within one week prior to symptom onset (aspirin is allowed).

Trial design

Design model

Sequential

Treatments tested in this trial

  • Low dose group

    Drug

    The calculated injection amount of tenecteplase (tenecteplase injection amount = volume of intraventricular hematoma × 0.009 mg/ml) was diluted to 1ml with sterile injection water, and administered via the EVD.

  • Medium dose group

    Drug

    The calculated injection amount of tenecteplase (tenecteplase injection amount = volume of intraventricular hematoma × 0.018 mg/ml) was diluted to 1ml with sterile injection water, and administered via the EVD.

  • High dose group

    Drug

    The calculated injection amount of tenecteplase (tenecteplase injection amount = volume of intraventricular hematoma × 0.027 mg/ml) was diluted to 1ml with sterile injection water, and administered via the EVD.

Treatment groups

18 Participants
are divided into 3 treatment groups
Group A: Low dose rhTNK-tPA thrombolytic removal of intraventricular hemorrhageExperimental treatment 1 intervention
Group B: Medium dose rhTNK-tPA thrombolytic removal of intraventricular hemorrhageExperimental treatment 1 intervention
Group C: High dose rhTNK-tPA thrombolytic removal of intraventricular hemorrhageExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Drug-related new rebleeding events

CT examinations were performed every 24 hours after tenecteplase administration. Compared with the CT at the previous time point, a CT value of more than 72 HU and a volume of more than 5 ml were defined as newly emitted blood.

Time frame
24, 48, 72, and 96 hours after the first dose tenecteplase administration.

Secondary outcomes

1

Mortality rate

Death within 7 days of enrollment

Time frame
within 7 days of enrollment
2

Ventricular infection

fever and positive cerebrospinal fluid culture

Time frame
within 7 days of enrollment
3

Clot Removal

Change in blood volume measured between stability scan and 24 hours after the last dose.

Time frame
24 hours after the last dose.
4

Number of doses administered at the endpoint of the treatment

Record the number of doses administered at the endpoint of the treatment.

Time frame
24, 48, 72, and 96 hours after the first dose tenecteplase administration.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Tiantan Hospital

Lead sponsor

Source ClinicalTrials.gov
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