Prospective, Randomised Trial of Two Doses of rFVIIa (NovoSeven) in Haemophilia Patients with Inhibitors Undergoing Surgery

1998 ◽  
Vol 80 (11) ◽  
pp. 773-778 ◽  
Author(s):  
Gerald Gilchrist ◽  
W. Keith Hoots ◽  
Herbert Cooper ◽  
Dennis Gastineau ◽  
Amy Shapiro
Keyword(s):  
Factor Viia ◽  
Elective Surgery ◽  
Randomised Trial ◽  
Operative Management ◽  
High Dose ◽  
Double Blind Study ◽  
Open Label ◽  
Double Blind ◽  
Prospective Randomised Trial ◽  
Proven Efficacy

SummaryRecombinant factor VIIa (rFVIIa; NovoSeven® ; Novo Nordisk) has proven efficacy in the treatment of haemophilic patients with inhibitors. This prospective, double-blind study compared rFVIIa (35 vs. 90 μg/kg) in the initiation and maintenance of haemostasis during and after elective surgery. Patients with inhibitors (FVIII, n = 26; FIX, n = 3) received rFVIIa immediately prior to incision; intraoperatively as needed; every 2 h for the first 48 h; and every 2-6 h for the following 3 days. Haemostasis was evaluated during surgery, at 0, 8, 24 and 48 h and 3, 4 and 5 days after wound closure. After day 5, open-label rFVIIa (90 μg/kg) was available for maintenance. Intraoperative haemostasis was achieved in 28/29 patients. All high-dose patients and 12/15 low dose patients had satisfactory haemostasis during the first 48 h. Twenty-three patients (13/14 high dose) successfully completed the study. Although the 35 μg/kg dose is probably sub-optimal for post-operative management, at least in major procedures, rFVIIa 90 μg/kg is an effective first-line option in surgery for patients with inhibitors.

scholarly journals The effects of maternal and infant vitamin A supplementation on vitamin A status: a randomised trial in Kenya

2007 ◽  
Vol 98 (2) ◽  
pp. 422-430 ◽  
Author(s):  
R. A. Ayah ◽  
D. L. Mwaniki ◽  
P. Magnussen ◽  
A. E. Tedstone ◽  
T. Marshall ◽  
...  
Keyword(s):  
Vitamin A ◽  
Controlled Trial ◽  
Randomised Trial ◽  
Maternal Serum ◽  
High Dose ◽  
Serum Retinol ◽  
Double Blind ◽  
Vitamin A Supplementation ◽  
Factors Affecting ◽  
Vitamin A Status

Postpartum vitamin A supplementation of mothers and infants is recommended, but the efficacy has been questioned. In this double-blind, placebo-controlled trial, Kenyan mother–infant pairs were randomised to maternal vitamin A (400 000 IU) or placebo < 24 h postpartum, and infant vitamin A (100 000 IU) or placebo at 14 weeks. Milk retinol was determined at weeks 4, 14 and 26, and maternal and infant serum retinol at weeks 14 and 26. Infant retinol stores were assessed at week 26, using a modified relative dose response (MRDR) test. Among 564 women, serum retinol at 36 weeks gestation was 0·81 (sd 0·21) μmol/l, and 33·3 % were < 0·7 μmol/l. Maternal serum retinol was not different between groups, but milk retinol was higher in the vitamin A group: (0·67 v. 0·60 μmol/l; 0·52 v. 0·44 μmol/l; 0·50 v. 0·44 μmol/l at 4, 14 and 26 weeks, respectively). When expressed per gram fat, milk retinol was higher in the vitamin A group only at 4 weeks. Infant serum retinol was not different between groups. However, although most infants had deficient vitamin A stores (MRDR>0·06 %) at 26 weeks, vitamin A to infants, but not mothers, resulted in a lower proportion of infants with deficient vitamin A stores (69 v. 78 %). High-dose postpartum vitamin A supplementation failed to increase serum retinol and infant stores, despite modest effects on milk retinol. Infant supplementation, however, increased stores. There is a need for a better understanding of factors affecting absorption and metabolism of vitamin A.

High-Dose Oral and Intravenous Metoclopramide in Doxorubicin/Cyclophosphamide-Induced Emesis A Randomized Double-Blind Study

1987 ◽  
Vol 10 (3) ◽  
pp. 257-263 ◽  
Author(s):  
Stephen B. Edge ◽  
William K. Funkhouser ◽  
Arlene Berman ◽  
Claudia Seipp ◽  
Anne Tanner ◽  
...  
Keyword(s):  
Blind Study ◽  
High Dose ◽  
Double Blind Study ◽  
Double Blind ◽  
Dose Oral

scholarly journals A Clinical Comparison of Atracurium and Vecuronium in Women Undergoing Laparoscopy

1987 ◽  
Vol 15 (3) ◽  
pp. 310-316 ◽  
Author(s):  
M. A. Raynes ◽  
R. Chisholm ◽  
D. F. Woolner ◽  
J. M. Gibbs
Keyword(s):  
Sinus Bradycardia ◽  
Neuromuscular Block ◽  
Randomised Trial ◽  
Neuromuscular Monitoring ◽  
Double Blind ◽  
Duration Of Action ◽  
Prospective Randomised Trial ◽  
Clinical Comparison ◽  
Intraoperative Hypotension ◽  
Significant Difference

In a double blind, prospective, randomised trial in 30 women undergoing laparoscopy, atracurium and vecuronium were compared in equipotent (2 X ED95) doses. In the atracurium group, first twitch depression was significantly greater at one minute, and degree of fade significantly greater at one and two minutes, but thereafter neuromuscular monitoring showed no significant difference between the groups. Clinically there was no significant difference between the drugs. Mild intraoperative hypotension was equally common in both groups as was sinus bradycardia. Reversal and recovery were comparable in the two groups. Neostigmine was required in all patients and in three (one atracurium, two vecuronium) a second dose was administered on clinical grounds. Antagonism of the neuromuscular block is required with surgery of this duration despite the intermediate duration of action of the relaxant drugs.

scholarly journals High-Dose Adrenaline in Adult In-Hospital Asystolic Cardiopulmonary Resuscitation: A Double-Blind Randomised Trial

1993 ◽  
Vol 21 (2) ◽  
pp. 192-196 ◽  
Author(s):  
J. Lipman ◽  
W. Wilson ◽  
S. Kobilski ◽  
J. Scribante ◽  
C. Lee ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Cardiac Arrest ◽  
Intensive Care ◽  
Side Effects ◽  
Cardiopulmonary Resuscitation ◽  
Standard Dose ◽  
Randomised Trial ◽  
High Dose ◽  
Double Blind ◽  
To Receive

Forty intensive care unit patients requiring cardiopulmonary resuscitation were randomised to receive either the standard dose of adrenaline (1 mg every five minutes) or high-dose adrenaline (10 mg every five minutes). In the majority of patients, overwhelming sepsis was the major contributing factor leading to cardiac arrest. In this group of patients no difference could be detected in response to high-dose adrenaline compared with the standard dose. Although no side-effects were noted with this high dose of adrenaline, more investigation is required prior to its routine use in cardiopulmonary resuscitation.

scholarly journals M42. INDEPENDENT REVIEW & MONITORING IMPROVES QUALITY OF PANSS DATA IN GLOBAL CLINICAL TRIALS

2020 ◽  
Vol 46 (Supplement_1) ◽  
pp. S150-S150
Author(s):  
Barbara Echevarria ◽  
Cong Liu ◽  
Selam Negash ◽  
Mark Opler ◽  
Patricio Molero ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Data Quality ◽  
Working Group ◽  
Double Blind Study ◽  
Open Label ◽  
Rater Training ◽  
Double Blind ◽  
Open Label Extension ◽  
Expert Working Group ◽  
Independent Review

Abstract Background The Positive and Negative Syndrome Scale (PANSS) (1) is the most widely used endpoint for measuring change in schizophrenia clinical trials. A set of flags have been developed by ISCTM expert working group to identify potential scoring errors in PANSS assessments (2). Measures have been taken by sponsors (pharmaceutical industry) with the goal of increasing scoring reliability and data quality, such as the use of Independent Review (IRev). We evaluated changes in data quality when site raters stop being recorded and monitored via IRev by comparing two studies with the same cohort of raters, one with independent review and one without. Methods Data from PANSS assessments in two global multisite schizophrenia clinical trials were analyzed. We selected data from raters participating in both studies (which run concurrently for a significant period of time). Raters were rigorously trained on administration and scoring conventions and certified prior to the study through demonstration of adequate interrater reliability. In addition to these steps, raters in study A were required to audio record all PANSS assessments with a selected subset of visits being subject to IRev. PANSS assessments in study B were neither recorded nor monitored via IRev. Data quality after study completion was examined by calculating the frequency of anomalous data patterns identified as “high” (very probable or definite error) by the ISCTM Working Group in both studies. Additionally, we examined the percentage of assessments with lower than expected PANSS interview duration as captured via an eCOA platform. Results There were 9441 eCOA PANSS assessments in study A and 6178 in study B included in this analysis. The proportions of flags that represented highly probable/definite error differed significantly between the studies (9% vs 18% for Study A and B, respectively, p&lt;.01). The most significant differences in ISCTM flags were related to overly consistent scoring patterns (27 or more items scored identically to the prior visit) occurring with higher frequency in study B. Additionally, study B also had a significantly higher frequency of assessments flagged for low interview duration (&lt; 15 minutes) (1% vs 4% for Study A and B, respectively, p&lt;.01). Discussion Initial rater training is necessary but not sufficient to ensure adequate data quality in schizophrenia trials. Implementation of additional in-study oversight through Independent Review or similar methods reduces the probability of data error in PANSS assessments, including the appearance of improbable rating patterns and decreased time spent interviewing study subjects. One potential limitation is that study A is a double-blind study whereas study B is an open label extension of study A.

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