Early Blood Pressure Intervention After Coiling or Clipping for Subarachnoid Hemorrhage
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorBeijing Tiantan Hospital
About this trial
The goal of this clinical trial is to learn if elevating postoperative blood pressure works to improve prognosis in aneurysmal subarachnoid hemorrhage (aSAH) patients. The main questions it aims to answer are:
Does elevating postoperative blood pressure can improve the prognosis of aSAH ? What safety problems do participants have when received elevating blood pressure measurement?
Participants will:
Receive elevating or lowering blood pressure therapy in 72 hours after randomization, in order to maintain blood pressure within predefined target ranges Receive follow-up at 30 days, 90 days, and 180 days after randomization
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
1) Aged 18-75 years;
Disqualifiers
1) Presence of untreated intracranial aneurysms with rupture risk;
Trial design
Design model
Parallel
Treatments tested in this trial
Blood pressure was regulated within the normal target management range
Other interventionBlood pressure monitoring was initiated immediately upon the patient's return to the intensive care unit (ICU) postoperatively, followed by randomization. Blood pressure management was guided by systolic blood pressure (SBP) measurements, with physicians encouraged to adjust therapy based on institutional protocols and clinical judgment. For SBP \<120 mmHg, intravenous crystalloid or colloid fluid resuscitation was prioritized. If the target blood pressure was not achieved, norepinephrine infusion was initiated at a minimum dose of 0.1 µg/kg/min and titrated up to a maximum of 0.5 µg/kg/min to maintain SBP between 120-160 mmHg (\<160 mmHg and \>120 mmHg). For SBP \>160 mmHg, intravenous or oral antihypertensive drugs were administered to reduce and maintain SBP within the 120-160 mmHg range. For SBP within the range of 120-160 mmHg, standard supportive care was provided.
Blood pressure was regulated within the elevated target management range
Other interventionBlood pressure monitoring was initiated immediately upon the patient's return to the intensive care unit (ICU) postoperatively, followed by randomization. Blood pressure management was guided by systolic blood pressure (SBP) measurements, with physicians encouraged to adjust therapy based on institutional protocols and clinical judgment. For SBP \<160 mmHg, intravenous crystalloid or colloid fluid resuscitation was prioritized. If the target blood pressure was not achieved, norepinephrine infusion was initiated at a minimum dose of 0.1 µg/kg/min and titrated up to a maximum of 0.5 µg/kg/min to maintain SBP between 160-180 mmHg ( ≥160 mmHg and ≤120 mmHg). For SBP \>180 mmHg, intravenous or oral antihypertensive drugs were administered to reduce and maintain SBP within the 120-160 mmHg range. For SBP within the range of 160-180 mmHg, standard supportive care was provided.
Treatment groups
750 Participants
are divided into 2 treatment groupsGroup A: Normal Target Blood PressureActive comparator 1 intervention
Group B: Elevated Target Blood PressureExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Functional outcome
The modified Rankin Scale (mRS), a scale ranging from 0 (no symptoms) to 6 (death), is a precise and effective tool to assess the functional outcome of patients.
Time frame
Patients received follow-up through telephone consultations or outpatient appointments in the 180 days after randomization. The functional outcome was assessed by the mRS at 90 days post-discharge. mRS 0-2 was considered as favorable clinical outcome.Sponsors and contacts
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Beijing Tiantan Hospital
Lead sponsor
Development Center for Medical Science & Technology National Health Commission of the People's Republic of China
Collaborator
Tianjin Medical University General Hospital
Collaborator
Source ClinicalTrials.gov
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