- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00657228
Intravenous Heparin as an Adjunct for the Treatment of Anaphylactic Reactions in an Emergency Department
Intravenous Heparin as an Adjunct for the Treatment of Anaphylactic/Anaphylactoid Reactions in the Emergency Department
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Missouri
-
Kansas City, Missouri, Forenede Stater, 64108
- Truman Medical Center ED
-
Kansas City, Missouri, Forenede Stater
- St. Luke's Hospital ED
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 18 years and older
- English speaking
- Meets one of the above definitions of anaphylaxis
- Signs/symptoms onset <12 hours will get epinephrine or will not get epinephrine because of contraindication to epinephrine administration.
Exclusion Criteria:
- History of Intracranial Hemorrhage at anytime
- Known Cerebral Vascular Lesion (i.e. Aneurysm, Arteriovenous malformation)
- Ischemic CVA within the last 3 months
- Suspected Aortic Dissection
- Active Bleeding
- Known Bleeding/Clotting Disorder
- Closed Head Trauma within the past 3 months
- Major Surgery (Abdominal/Thoracic) within the last 3 weeks
- Active GI Bleeding
- Currently taking Warfarin
- Allergy to Heparins
- History of Heparin-induced Thrombocytopenia (AHA contraindications to fibrinolytic therapy 2005, Micromedix 2007)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Placebo komparator: 2
Standard treatment (epinephrine, corticosteroids, diphenhydramine, and H2 blockers) plus an equal volume bolus of normal saline after the first doses are administered.
|
Standard treatment (epinephrine, corticosteroids, diphenhydramine, and H2 blockers) and saline.
|
Eksperimentel: 1
Standard therapy plus a one-time bolus of heparin at 80 U/kg (maximum dose of 10,000 Units) given immediately after the first doses of standard treatment.
|
Intravenous heparin as an adjunct for the treatment of anaphylactic/anaphylactoid reactions in the Emergency Department. To determine if a single bolus of intravenous unfractionated heparin (in conjunction with standard therapy) given to patients with anaphylactic/anaphylactoid reactions results in a faster time to recovery when compared to standard therapy alone. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Time to improve to a severity score of 1 or complete resolution of signs/symptoms.
Tidsramme: 6 hours
|
6 hours
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Ryan Jacobsen, MD, Truman Medical Center
- Ledende efterforsker: Stefanie Ellison, MD, Truman Medical Center
Publikationer og nyttige links
Generelle publikationer
- Sampson HA, Munoz-Furlong A, Campbell RL, Adkinson NF Jr, Bock SA, Branum A, Brown SG, Camargo CA Jr, Cydulka R, Galli SJ, Gidudu J, Gruchalla RS, Harlor AD Jr, Hepner DL, Lewis LM, Lieberman PL, Metcalfe DD, O'Connor R, Muraro A, Rudman A, Schmitt C, Scherrer D, Simons FE, Thomas S, Wood JP, Decker WW. Second symposium on the definition and management of anaphylaxis: summary report--Second National Institute of Allergy and Infectious Disease/Food Allergy and Anaphylaxis Network symposium. J Allergy Clin Immunol. 2006 Feb;117(2):391-7. doi: 10.1016/j.jaci.2005.12.1303.
- Greenberg MR. Response to: Heparin reverses anaphylactoid shock in a porcine model. Ann Emerg Med. 2007 Apr;49(4):541-2; author reply 542. doi: 10.1016/j.annemergmed.2006.09.033. No abstract available.
- Heflin CR, Brewer KL, Hack JB, Meggs WJ. Heparin reverses anaphylactoid shock in a porcine model. Ann Emerg Med. 2006 Aug;48(2):190-3. doi: 10.1016/j.annemergmed.2006.03.029. Epub 2006 Jun 22.
- Gaeta TJ, Clark S, Pelletier AJ, Camargo CA. National study of US emergency department visits for acute allergic reactions, 1993 to 2004. Ann Allergy Asthma Immunol. 2007 Apr;98(4):360-5. doi: 10.1016/S1081-1206(10)60883-6.
- Brown SG, Mullins RJ, Gold MS. Anaphylaxis: diagnosis and management. Med J Aust. 2006 Sep 4;185(5):283-9. doi: 10.5694/j.1326-5377.2006.tb00619.x. Erratum In: Med J Aust. 2006 Oct 2;185(7):400. Dosage error in article text.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 07-58
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