PMID- 37422666
OWN - NLM
STAT- MEDLINE
DCOM- 20230710
LR  - 20230718
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 24
IP  - 1
DP  - 2023 Jul 8
TI  - Effects of low-dose intravenous heparin therapy in aneurysmal subarachnoid 
      hemorrhage: a randomized controlled clinical trial protocol.
PG  - 447
LID - 10.1186/s13063-023-07493-9 [doi]
LID - 447
AB  - BACKGROUND: Heparin anticoagulation therapy is a widely used method to prevent 
      cerebral vasospasm (CV) and venous thrombosis in patients with subarachnoid 
      hemorrhage caused by ruptured cerebral aneurysms. Subcutaneous heparin injection 
      is considered safe and effective, whereas continuous intravenous heparin infusion 
      is still being debated due to the risk of bleeding. Although most retrospective 
      studies have confirmed the safety and effectiveness of unfractionated heparin 
      (UFH) after aneurysm embolization therapy and its ability to reduce CV, there is 
      still no randomized clinical trial comparing UFH and subcutaneous 
      low-molecular-weight heparin (LMWH) injection in this population. Therefore, this 
      study aims to compare the clinical outcomes associated with these two treatment 
      approaches. METHODS: The study is an open-label, single-center, randomized 
      controlled trial and aims to recruit 456 patients, with 228 patients in each 
      group. The primary outcome was CV; the second outcomes measures are occurrence of 
      bleeding events, ischemic events, heparin-induced thrombocytopenia, deep vein 
      thrombosis, cerebral venous circulation time, brain edema score, and 
      hydrocephalus incidence. ETHICS AND DISSEMINATION: This study protocol obtained 
      ethical approval from the Ethics Committee of Baoan People's Hospital, Shenzhen, 
      Guangdong (approval number: BYL20220805). This work will be published in 
      peer-reviewed international medical journals and presented at medical 
      conferences. TRIAL REGISTRATION: ClinicalTrials ID: NCT05696639. Registered on 
      March 30, 2023.
CI  - (c) 2023. The Author(s).
FAU - Zhang, Yifan
AU  - Zhang Y
AD  - Department of Neurology, ShenZhen BaoAn People's Hospital, ShenZhen, China.
FAU - Hu, Jiangang
AU  - Hu J
AD  - Department of Neurosurgery, ShenZhen BaoAn People's Hospital, ShenZhen, China. 
      baoanhjg@outlook.com.
LA  - eng
SI  - ClinicalTrials.gov/NCT05696639
GR  - 202214/Youth Scientific Research Foundation of Shenzhen Baon People's Hospital./
PT  - Clinical Trial Protocol
PT  - Journal Article
DEP - 20230708
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
RN  - 9005-49-6 (Heparin)
RN  - 0 (Heparin, Low-Molecular-Weight)
RN  - 0 (Anticoagulants)
SB  - IM
MH  - Humans
MH  - *Heparin/adverse effects
MH  - Heparin, Low-Molecular-Weight/therapeutic use
MH  - *Subarachnoid Hemorrhage/diagnosis/drug therapy
MH  - Retrospective Studies
MH  - Anticoagulants/therapeutic use
MH  - Randomized Controlled Trials as Topic
PMC - PMC10329784
OTO - NOTNLM
OT  - Aneurysmal subarachnoid hemorrhage
OT  - RCT protocol
OT  - Randomized controlled trial
COIS- The author declare no competing interests.
EDAT- 2023/07/09 01:07
MHDA- 2023/07/10 06:42
PMCR- 2023/07/08
CRDT- 2023/07/08 23:29
PHST- 2023/06/03 00:00 [received]
PHST- 2023/07/03 00:00 [accepted]
PHST- 2023/07/10 06:42 [medline]
PHST- 2023/07/09 01:07 [pubmed]
PHST- 2023/07/08 23:29 [entrez]
PHST- 2023/07/08 00:00 [pmc-release]
AID - 10.1186/s13063-023-07493-9 [pii]
AID - 7493 [pii]
AID - 10.1186/s13063-023-07493-9 [doi]
PST - epublish
SO  - Trials. 2023 Jul 8;24(1):447. doi: 10.1186/s13063-023-07493-9.