Treatment of Sickle Cell Patients Hospitalized in Pain Crisis With Prophylactic Dose Low-molecular-weight Heparin (LMWH) Versus Placebo
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|ClinicalTrials.gov Identifier: NCT01419977|
Recruitment Status : Completed
First Posted : August 19, 2011
Results First Posted : February 16, 2015
Last Update Posted : February 16, 2015
|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Disease Vaso-occlusive Crisis||Drug: Placebo Drug: Dalteparin||Phase 2|
This is a double blind prospective randomized placebo controlled study with an enrollment target of 100 patients. All subjects with SCD that meet inclusion criteria while inpatient, will be eligible for the study and randomized to receive prophylactic LMWH or placebo. Treatment with either LMWH (dalteparin 5000 IU subcutaneously daily) or placebo will occur for the initial 7 days of hospitalization. Randomization will occur within Investigational Drug Services, which will dispense and label medications to all patients. All patients will be followed throughout their hospitalization as well as in the outpatient clinic. The initial blood sample will be obtained within 36 hours of admission.
Following randomization, blood will be drawn to perform: D-dimer, prothrombin fragment 1.2, thrombin-antithrombin complex, and Thrombin Generation Assay (TGA). Blood will be drawn as an inpatient (at admission, day 3, and day 5), as well as during a single outpatient follow-up visit two weeks post discharge. Patients with prolonged hospitalization will only have blood drawn on admission, day 3, and day 5, with a final blood draw as an outpatient (at least 14 days after discharge). Treatment by prophylactic LMWH or placebo will occur for the initial 7 days of hospitalization or until discharge.
Clinical pain scores will be performed twice daily throughout for the initial 7 days of hospitalization of all patients. The primary pain assessment tool will be a 10-cm horizontal visual analog scale (VAS), with "0" corresponding to no pain at one end and "10" indicating the worst pain at the other. The VAS test will be administered by the same blinded study coordinator or PI throughout the study, using standardized instructions. Pain will also be assessed during the follow up outpatient visit (to confirm patient's pain has returned to their baseline).
Patients will be recommended to follow up in outpatient clinic approximately 2-4 week following hospitalization. At this time, patients will be examined, have their clinical pain score determined, and have final blood draw for testing as detailed above. Should patients not return within 4 weeks, patient will be contacted by phone to determine their clinical status.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Randomized Double Blind Placebo Controlled Treatment of Sickle Cell Patients Hospitalized in Pain Crisis With Prophylactic Dose LMWH Versus Placebo|
|Study Start Date :||May 2011|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2014|
Placebo Comparator: Placebo
Normal saline solution
Normal saline solution, administered by nursing staff once daily
5000 unites subcutaneously, Other Name: Fragmin
Low molecular weight heparin (LMWH), 5000 unites subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
- Change in D-dimer [ Time Frame: Day 1 and Day 3 ]Patients will have D-dimer,for samples drawn on Day 1 and Day 3
- Change in Clinical Pain Scores [ Time Frame: Baseline to day 1 ]The primary pain assessment tool will be a 10-cm horizontal visual analog scale (VAS), with "0" corresponding to no pain at one end and "10" indicating the worst pain at the other.
- Change in Thrombin Generation Assay - Endogenous Thrombin Potential [ Time Frame: Day 1 and Day 3 ]Patients will have thrombin generation assay samples drawn on Day 1 and 3
- Change in Clinical Pain Scores [ Time Frame: Baseline to day 3 ]The primary pain assessment tool will be a 10-cm horizontal visual analog scale (VAS), with "0" corresponding to no pain at one end and "10" indicating the worst pain at the other.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01419977
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Nirmish Shah, MD||Duke University|